What is Jencycla?

Jencycla is a form of progesterone, a female hormone important for regulating ovulation and menstruation.

Jencycla is used for birth control (contraception) to prevent pregnancy.

Jencycla is also used to treat menstrual disorders, endometriosis, or abnormal vaginal bleeding caused by a hormone imbalance.

Not all brands of Jencycla are for the same uses. Some brands are for use only as contraception. Others are for use in treating endometriosis or vaginal bleeding disorders. Avoid medication errors by using only the brand, form, and strength your doctor prescribes.

Jencycla may also be used for other purposes not listed in this medication guide.

Jencycla side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Jencycla may cause serious side effects. Call your doctor at once if you have:

• sudden vision loss, bulging eyes, or severe headache;
• swelling, rapid weight gain;
• unusual vaginal bleeding;
• missed menstrual periods;
• pelvic pain (especially on one side);
• a breast lump;
• a light-headed feeling, like you might pass out;
• increased thirst, increased urination;
• liver problems–loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes); or
• signs of a blood clot–sudden numbness or weakness, problems with vision or speech, chest pain, shortness of breath, swelling or redness in an arm or leg.

Common side effects of Jencycla may include:

• irregular vaginal bleeding or spotting;
• headache;
• breast pain or swelling;
• stomach pain, bloating, nausea, vomiting;
• hair loss;
• depressed mood, trouble sleeping;
• weight gain; or
• vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

You should not use Jencycla if you you have: undiagnosed vaginal bleeding, breast cancer, liver disease, or a liver tumor. You may not be able to take Jencycla if you have ever had a heart attack, a stroke, or blood clot.

Do not use if you are pregnant or trying to become pregnant.

In some cases, you should not take Jencycla if you are nursing.

Before taking this medicine

You should not use Jencycla if you are allergic to it, or if you have:

• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease or a liver tumor;
• breast cancer; or
• a history of blood clots in your brain, eyes, lungs, or legs.

Do not use Jencycla if you are pregnant or trying to become pregnant. Stop taking the medicine and tell your doctor right away if you become pregnant.

Ask your doctor about using this medicine while you are breast-feeding. In some cases, you should not take Jencycla if you are nursing.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;
• liver disease;
• depression;
• migraine headaches;
• diabetes;
• high cholesterol or triglycerides;
• uterine fibroid tumors;
• epilepsy;
• kidney disease;
• asthma; or
• if you smoke.

Do not give this medicine to a child without medical advice.

How should I take Jencycla?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Carefully follow your doctor’s dosing instructions about when to start taking Jencycla for contraception if you are switching from a combination birth control pill (estrogen and progestin).

If you take Jencycla for contraception: Take one pill every day, no more than 24 hours apart. You may get pregnant if you do not take one pill daily.

You may need to use back-up birth control (such as condoms with spermicide) if you are sick with vomiting or diarrhea, or if you are 3 or more hours late in taking your daily dose.

If you take Jencycla for menstrual disorders or abnormal vaginal bleeding: You will most likely take the medicine for only 5 to 10 days. Vaginal bleeding will occur 3 to 7 days after your last dose.

If you take Jencycla for endometriosis: This medicine is usually taken daily long-term for several months. Your doctor may occasionally change your dose.

Your doctor should check your progress on a regular basis. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms.

Report any unusual vaginal bleeding right away.

Jencycla can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.

Store this medication at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Call your doctor for instructions, or follow the patient instructions provided with your medicine.

Missing a birth control pill increases your risk of becoming pregnant. If you are more than 3 hours late for your dose, take the medicine as soon as you remember and use back-up birth control for at least 48 hours. Take your next pill at the regularly scheduled time and continue on your regular dosing schedule.

If you miss a period for two months in a row, call your doctor because you might be pregnant.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

An overdose of Jencycla is not expected to be dangerous.

What should I avoid while taking norethindrone?

Do not use estrogen medication unless your doctor tells you to.

Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while taking Jencycla for contraception.

Jencycla will not protect you from sexually transmitted diseases–including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

What other drugs will affect Jencycla?

Some drugs can make Jencycla less effective, which may result in unintended pregnancy if you use Jencycla for contraception. Tell your doctor about all your other medicines, especially:

• St. John’s wort;
• medicine to treat an infection (antibiotics or antifungal medicine);
• medicine to treat tuberculosis;
• medicine to treat HIV or AIDS; or
• seizure medication.

Oral route(Tablet)

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women older than 35 years, and with the number of cigarettes smoked. Women who use oral contraceptives should be strongly advised not to smoke .

Uses for Jolessa

Levonorgestrel and ethinyl estradiol combination is used to prevent pregnancy. It works by stopping a woman’s egg from fully developing each month. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.

This medicine will not prevent HIV infection or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

This medicine is available only with your doctor’s prescription.

Before using Jolessa

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of levonorgestrel and ethinyl estradiol combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.

Geriatric

No information is available on the relationship of age to the effects of levonorgestrel and ethinyl estradiol combination in geriatric patients. This medicine is not indicated for use in elderly women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amifampridine
• Amobarbital
• Amoxicillin
• Ampicillin
• Amprenavir
• Anagrelide
• Apalutamide
• Aprepitant
• Armodafinil
• Artemether
• Bacampicillin
• Belzutifan
• Betamethasone
• Bexarotene
• Boceprevir
• Bosentan
• Bupropion
• Butabarbital
• Butalbital
• Carbamazepine
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixime
• Cefpodoxime
• Cefprozil
• Ceftazidime
• Ceftibuten
• Cefuroxime
• Cenobamate
• Ceritinib
• Clobazam
• Cloxacillin
• Cobicistat
• Colesevelam
• Cyclacillin
• Cyclosporine
• Dabrafenib
• Darunavir
• Dexamethasone
• Dicloxacillin
• Dipyrone
• Donepezil
• Doxycycline
• Efavirenz
• Elagolix
• Elvitegravir
• Encorafenib
• Enzalutamide
• Eslicarbazepine Acetate
• Etravirine
• Felbamate
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Fostemsavir
• Glecaprevir
• Grazoprevir
• Griseofulvin
• Guar Gum
• Indinavir
• Iron
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lixisenatide
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mephobarbital
• Meropenem
• Methohexital
• Minocycline
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafcillin
• Nelfinavir
• Nevirapine
• Nirmatrelvir
• Octreotide
• Oxacillin
• Oxcarbazepine
• Oxytetracycline
• Paclitaxel
• Paclitaxel Protein-Bound
• Penicillin G
• Penicillin G Procaine
• Penicillin V
• Pentobarbital
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pibrentasvir
• Piperaquine
• Pitolisant
• Prednisolone
• Prednisone
• Primidone
• Red Clover
• Rifabutin
• Rifampin
• Rifapentine
• Rilpivirine
• Ritonavir
• Rufinamide
• Saquinavir
• Secobarbital
• Simeprevir
• Somatrogon-ghla
• St John’s Wort
• Sugammadex
• Sultamicillin
• Tazemetostat
• Telaprevir
• Telotristat Ethyl
• Tetracycline
• Theophylline
• Thiopental
• Thioridazine
• Ticarcillin
• Tigecycline
• Tirzepatide
• Tizanidine
• Topiramate
• Troglitazone
• Ulipristal
• Valproic Acid
• Voxilaprevir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acitretin
• Amitriptyline
• Atazanavir
• Atorvastatin
• Clomipramine
• Diazepam
• Doxepin
• Etoricoxib
• Ginseng
• Imipramine
• Lamotrigine
• Levothyroxine
• Licorice
• Liothyronine
• Lorazepam
• Parecoxib
• Perampanel
• Roflumilast
• Selegiline
• Tacrine
• Temazepam
• Tipranavir
• Triazolam
• Troleandomycin
• Valdecoxib
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (eg, deep vein thrombosis, pulmonary embolism), or history of or
• Breast cancer, known or suspected or
• Diabetes with kidney, eye, nerve, or blood vessel damage or
• Heart attack, history of or
• Heart or blood vessel disease (eg, coronary artery disease, heart valve problems), or history of or
• Hypertension (high blood pressure), uncontrolled or
• Jaundice during pregnancy or from using hormonal treatment in the past or
• Liver disease, including tumors or cancer or
• Stroke, history of or
• Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.

• Depression, history of or
• Epilepsy, history of or
• Gallbladder disease, history of or
• Hereditary angioedema (swelling of the face, tongue, or throat) or
• Hyperlipidemia (high cholesterol or fats in the blood) or
• Kidney disease or
• Migraine headache—May make these conditions worse.

• Diarrhea or
• Vomiting—May decrease the absorption of levonorgestrel and ethinyl estradiol combination in the body.

Proper use of Jolessa

It is very important that you use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

When you begin using this medicine, your body will require at least 7 days to adjust before a pregnancy will be prevented. Use a second form of birth control, such as a condom, spermicide, or diaphragm, for the first 7 days of your first cycle of pills.

Take this medicine at the same time each day. Birth control pills work best when no more than 24 hours pass between doses.

Do not skip or delay taking your pill by more than 24 hours. If you miss a dose, you could get pregnant. Ask your doctor for ways to help you remember to take your pills or about using another method of birth control.

You may feel sick or nauseated, especially during the first few months that you take this medicine. If your nausea is continuous and does not go away, call your doctor.

Use another form of birth control if you vomit or have diarrhea after taking the pills until you check with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 start) or on the first Sunday after your menstrual period starts (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even if you miss a dose. Do not change your schedule on your own. If the schedule that you use is not convenient, talk with your doctor about changing it. For a Sunday start, you need to use another form of birth control (eg, condom, diaphragm, spermicide) for the first 7 days.

• For oral dosage form (tablets):
  • For contraception (to prevent pregnancy):
    • Chateal®:
      • Adults—One white to off-white tablet (active) taken at the same time each day for 21 consecutive days followed by one green (inert) tablet daily for 7 days per menstrual cycle.
      • Children—Use and dose must be determined by your doctor.
    • Triphasil®-28:
      • Adults—One brown, white, light-yellow (in order) (active) tablet taken at the same time each day for 21 consecutive days followed by one light-green (inert) tablet daily for 7 days per menstrual cycle.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

This medicine has specific patient instructions on what to do if you miss a dose. Read and follow these instructions carefully and call your doctor if you have any questions.

• If you miss one active pill: Take it as soon as you can, then take your next pill at your regular schedule. This means you may take 2 pills in 1 day.
• If you miss two active pills in week 1 or 2: Take two pills as soon as you can and two more pills the next day. Continue taking one pill a day until you finish the pack. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose.
• If you miss two active pills in week 3, or you miss three or more active pills in a row in weeks 1, 2, or 3:
  • Day 1 start: Throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose.
  • Sunday start: Continue taking one pill a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy.
• You could have light bleeding or spotting if you do not take a pill on time. The more pills you miss, the more likely you are to have bleeding.
• Make sure your doctor knows if you miss your period 2 months in a row, because this could mean that you are pregnant.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions while using Jolessa

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may also be needed to check for unwanted effects. Your doctor may also want to check your blood pressure while taking this medicine.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Make sure your doctor knows if you had given birth within 4 weeks before you start using this medicine.

If you suspect that you may be pregnant, check with your doctor right away.

Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).

You might have some light bleeding or spotting when you first start using this medicine. This is usually normal and should not last long. However, if you have heavy bleeding or the bleeding lasts more than a few days in a row, call your doctor.

Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using ethinyl estradiol and norgestrel combination, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Using this medicine may increase your risk of having blood clotting problems. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, a sudden loss of coordination, or vision changes while using this medicine.

Using this medicine may increase your risk of having cancer of the breast or your reproductive organs (eg, endometrium, ovaries, cervix). Talk with your doctor about this risk. Check with your doctor right away if you experience abnormal vaginal bleeding.

Check with your doctor right away if you have pain or tenderness in the stomach, dark urine, pale stools, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want an eye doctor (ophthalmologist) to check your eyes.

This medicine may increase your risk of having gallbladder disease. Check with your doctor if you start to have stomach pains, nausea, and vomiting.

Make sure any doctor or dentist who treats you knows that you are using this medicine. The results of some medical tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John’s wort) or vitamin supplements.

Side Effects of Jolessa

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Absent, missed, or irregular menstrual periods
• anxiety
• bloody stools
• blurred vision
• breast tenderness, enlargement, discharge
• changes in skin color, pain, tenderness, or swelling of the foot or leg
• chest pain or discomfort
• chills
• clay-colored stools
• confusion
• cough
• dark or cloudy urine
• decrease in urine output or decrease in urine-concentrating ability
• diarrhea
• difficult, burning, or painful urination
• difficulty in speaking
• dizziness or lightheadedness
• double vision
• dull ache or feeling of pressure or heaviness in the legs
• fainting
• fast heartbeat
• fever
• fluid-filled skin blisters
• frequent urge to urinate
• headache, severe and throbbing
• inability to move the arms, legs, or facial muscles
• inability to speak
• itching of the vagina or outside the genitals
• itching skin near damaged veins
• light vaginal bleeding between regular menstrual periods
• loss of appetite
• nausea
• nervousness
• pain during sexual intercourse
• pain or discomfort in the arms, jaw, back or neck
• pelvic pain
• pounding in the ears
• sensitivity to the sun
• skin thinness
• slow or fast heartbeat
• slow speech
• stomach bloating and cramping
• stomach pain and tenderness
• stopping of menstrual bleeding
• sweating
• swelling, pain, or tenderness in the upper abdominal area
• swollen feet and ankles
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
• thick, white curd-like vaginal discharge without odor or with mild odor
• troubled breathing
• twitching, uncontrolled movements of the tongue, lips, face, arms, or legs
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting
• vomiting of blood
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Acne
• changes in appetite
• changes in weight
• decreased interest in sexual intercourse
• decreased milk production
• loss in sexual ability, desire, drive, or performance
• mental depression
• patchy brown or dark brown discoloration of the skin

What is Jolivette?

Jolivette is a form of progesterone, a female hormone important for regulating ovulation and menstruation.

Jolivette is used for birth control (contraception) to prevent pregnancy.

Jolivette is also used to treat menstrual disorders, endometriosis, or abnormal vaginal bleeding caused by a hormone imbalance.

Not all brands of Jolivette are for the same uses. Some brands are for use only as contraception. Others are for use in treating endometriosis or vaginal bleeding disorders. Avoid medication errors by using only the brand, form, and strength your doctor prescribes.

Jolivette may also be used for other purposes not listed in this medication guide.

Jolivette side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Jolivette may cause serious side effects. Call your doctor at once if you have:

• sudden vision loss, bulging eyes, or severe headache;
• swelling, rapid weight gain;
• unusual vaginal bleeding;
• missed menstrual periods;
• pelvic pain (especially on one side);
• a breast lump;
• a light-headed feeling, like you might pass out;
• increased thirst, increased urination;
• liver problems–loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes); or
• signs of a blood clot–sudden numbness or weakness, problems with vision or speech, chest pain, shortness of breath, swelling or redness in an arm or leg.

Common side effects of Jolivette may include:

• irregular vaginal bleeding or spotting;
• headache;
• breast pain or swelling;
• stomach pain, bloating, nausea, vomiting;
• hair loss;
• depressed mood, trouble sleeping;
• weight gain; or
• vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

You should not use Jolivette if you you have: undiagnosed vaginal bleeding, breast cancer, liver disease, or a liver tumor. You may not be able to take Jolivette if you have ever had a heart attack, a stroke, or blood clot.

Do not use if you are pregnant or trying to become pregnant.

In some cases, you should not take Jolivette if you are nursing.

Before taking this medicine

You should not use Jolivette if you are allergic to it, or if you have:

• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease or a liver tumor;
• breast cancer; or
• a history of blood clots in your brain, eyes, lungs, or legs.

Do not use Jolivette if you are pregnant or trying to become pregnant. Stop taking the medicine and tell your doctor right away if you become pregnant.

Ask your doctor about using this medicine while you are breast-feeding. In some cases, you should not take Jolivette if you are nursing.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;
• liver disease;
• depression;
• migraine headaches;
• diabetes;
• high cholesterol or triglycerides;
• uterine fibroid tumors;
• epilepsy;
• kidney disease;
• asthma; or
• if you smoke.

Do not give this medicine to a child without medical advice.

How should I take Jolivette?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Carefully follow your doctor’s dosing instructions about when to start taking Jolivette for contraception if you are switching from a combination birth control pill (estrogen and progestin).

If you take Jolivette for contraception: Take one pill every day, no more than 24 hours apart. You may get pregnant if you do not take one pill daily.

You may need to use back-up birth control (such as condoms with spermicide) if you are sick with vomiting or diarrhea, or if you are 3 or more hours late in taking your daily dose.

If you take Jolivette for menstrual disorders or abnormal vaginal bleeding: You will most likely take the medicine for only 5 to 10 days. Vaginal bleeding will occur 3 to 7 days after your last dose.

If you take Jolivette for endometriosis: This medicine is usually taken daily long-term for several months. Your doctor may occasionally change your dose.

Your doctor should check your progress on a regular basis. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms.

Report any unusual vaginal bleeding right away.

Jolivette can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.

Store this medication at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Call your doctor for instructions, or follow the patient instructions provided with your medicine.

Missing a birth control pill increases your risk of becoming pregnant. If you are more than 3 hours late for your dose, take the medicine as soon as you remember and use back-up birth control for at least 48 hours. Take your next pill at the regularly scheduled time and continue on your regular dosing schedule.

If you miss a period for two months in a row, call your doctor because you might be pregnant.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

An overdose of Jolivette is not expected to be dangerous.

What should I avoid while taking norethindrone?

Do not use estrogen medication unless your doctor tells you to.

Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while taking Jolivette for contraception.

Jolivette will not protect you from sexually transmitted diseases–including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

What other drugs will affect Jolivette?

Some drugs can make Jolivette less effective, which may result in unintended pregnancy if you use Jolivette for contraception. Tell your doctor about all your other medicines, especially:

• St. John’s wort;
• medicine to treat an infection (antibiotics or antifungal medicine);
• medicine to treat tuberculosis;
• medicine to treat HIV or AIDS; or
• seizure medication.

Oral route(Tablet)

Junel(R): Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including Junel, are contraindicated in women who are over 35 years of age and smoke .Microgestin(R): Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

Uses for Junel 1.5/30

Ethinyl estradiol and norethindrone combination is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, ethinyl estradiol and norethindrone, and when taken properly, prevents pregnancy. It works by stopping a woman’s egg from fully developing each month. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented.

No contraceptive method is 100 percent effective. Birth control methods, such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.

This medicine does not prevent HIV infection or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

This medicine is available only with your doctor’s prescription.

Before using Junel 1.5/30

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of ethinyl estradiol and norethindrone combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.

Geriatric

No information is available on the relationship of age to the effects of ethinyl estradiol and norethindrone combination in the geriatric patients.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amifampridine
• Amobarbital
• Amoxicillin
• Ampicillin
• Amprenavir
• Anagrelide
• Apalutamide
• Aprepitant
• Armodafinil
• Artemether
• Bacampicillin
• Belzutifan
• Betamethasone
• Bexarotene
• Boceprevir
• Bosentan
• Bupropion
• Butabarbital
• Butalbital
• Carbamazepine
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixime
• Cefpodoxime
• Cefprozil
• Ceftazidime
• Ceftibuten
• Cefuroxime
• Cenobamate
• Ceritinib
• Clobazam
• Cloxacillin
• Cobicistat
• Colesevelam
• Cyclacillin
• Cyclosporine
• Dabrafenib
• Darunavir
• Dexamethasone
• Dicloxacillin
• Dipyrone
• Donepezil
• Doxycycline
• Efavirenz
• Elagolix
• Elvitegravir
• Encorafenib
• Enzalutamide
• Eslicarbazepine Acetate
• Etravirine
• Felbamate
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Fostemsavir
• Glecaprevir
• Grazoprevir
• Griseofulvin
• Guar Gum
• Indinavir
• Iron
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lixisenatide
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mephobarbital
• Meropenem
• Methohexital
• Minocycline
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafcillin
• Nelfinavir
• Nevirapine
• Nirmatrelvir
• Octreotide
• Oxacillin
• Oxcarbazepine
• Oxytetracycline
• Paclitaxel
• Paclitaxel Protein-Bound
• Penicillin G
• Penicillin G Procaine
• Penicillin V
• Pentobarbital
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pibrentasvir
• Piperaquine
• Pitolisant
• Prednisolone
• Prednisone
• Primidone
• Red Clover
• Rifabutin
• Rifampin
• Rifapentine
• Rilpivirine
• Ritonavir
• Rufinamide
• Saquinavir
• Secobarbital
• Simeprevir
• Somatrogon-ghla
• St John’s Wort
• Sugammadex
• Sultamicillin
• Tazemetostat
• Telaprevir
• Telotristat Ethyl
• Tetracycline
• Theophylline
• Thiopental
• Thioridazine
• Ticarcillin
• Tigecycline
• Tipranavir
• Tirzepatide
• Tizanidine
• Topiramate
• Troglitazone
• Ulipristal
• Valproic Acid
• Voxilaprevir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amitriptyline
• Atazanavir
• Atorvastatin
• Clomipramine
• Diazepam
• Doxepin
• Etoricoxib
• Ginseng
• Imipramine
• Lamotrigine
• Levothyroxine
• Licorice
• Liothyronine
• Lorazepam
• Parecoxib
• Roflumilast
• Selegiline
• Temazepam
• Tipranavir
• Triazolam
• Troleandomycin
• Valdecoxib
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (eg, deep vein thrombosis, pulmonary embolism), or history of or
• Breast cancer, known or suspected or
• Diabetes with kidney, eye, nerve, or blood vessel damage or
• Endometrial cancer or
• Heart attack, history of or
• Heart or blood vessel disease (eg, coronary artery disease, heart valve problems), or history of or
• Hypertension (high blood pressure) that is not under good control, or
• Jaundice during pregnancy or from using hormonal therapy in the past or
• Liver disease, including tumors or cancer or
• Major surgery with prolonged periods of immobilization or
• Migraine headache or
• Stroke, history of or
• Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.

• Breast cancer, family history of or
• Cervical cancer or
• Depression, history of or
• Edema (fluid retention or body swelling) or
• Epilepsy (seizures) or
• Gallbladder disease or
• Hypertension (high blood pressure)—Use with caution. May make these conditions worse.

• Diabetes or
• Hyperlipidemia (high cholesterol or fats in the blood) or
• Kidney disease or
• Obesity, or history of—Use with caution. These conditions may increase risk for more serious side effects.

Proper use of Junel 1.5/30

It is very important that you use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

To make using oral contraceptives as safe and reliable as possible, you should understand how and when to take them and what effects may be expected.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine is available in blister packs with a Dialpak® tablet dispenser. Each blister pack contains 28 tablets with different colors that need to be taken in the same order as directed on the blister pack.

When you begin using this medicine, your body will require at least 7 days to adjust before a pregnancy will be prevented. Use a second form of contraception, such as a condom, spermicide, or diaphragm, for the first 7 days of your first cycle of pills.

Take this medicine at the same time each day (with meals or at bedtime). Birth control pills work best when no more than 24 hours pass between doses.

Do not skip or delay taking your pill by more than 24 hours. If you miss a dose, you could get pregnant. Ask your doctor for ways to help you remember to take your pills or about using another method of birth control.

You may feel sick or nauseated, especially during the first few months that you take this medicine. If your nausea is continuous and does not go away, call your doctor.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 start) or on the first Sunday after your menstrual period starts (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even if you miss a dose. Do not change your schedule on your own. If the schedule that you use is not convenient, check with your doctor about changing it. For a Sunday start, you need to use another form of birth control (eg, condom, diaphragm, spermicide) for the first 7 days.

You should begin your next and all subsequent 28-day regimens of therapy on the same day of the week as the first regimen began and follow the same schedule.

• For oral dosage form (tablets):
  • For contraception (to prevent pregnancy):
    • Adults and teenagers—
      • Loestrin® 21: One white or green tablet (active) taken at the same time each day for 21 consecutive days followed by one week without the tablets.
      • Loestrin® Fe: One white or green tablet (active) taken at the same time each day for 21 consecutive days followed by one brown (inert) tablet daily for 7 days per menstrual cycle.
      • Modicon®: One white tablet (active) taken at the same time each day for 21 consecutive days followed by one green (inert) tablet daily for 7 days per menstrual cycle.
      • Ortho-novum®: One white or peach tablet (active) taken at the same time each day for 21 consecutive days followed by one green (inert) tablet daily for 7 days per menstrual cycle.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

This medicine has specific patient instructions on what to do if you miss a dose. Read and follow these instructions carefully and call your doctor if you have any questions.

• If you miss one active pill: Take it as soon as you can, then take your next pill at your regular schedule.
• If you miss two active pills in week 1 or 2: Take two pills as soon as you can and two more pills the next day. Continue taking one pill a day until you finish the pack. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose.
• If you miss two active pills in week 3, or you miss three or more active pills in a row in weeks 1, 2, or 3:
  • Day 1 start: Throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose.
  • Sunday start: Continue taking one pill a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy.

You may not have a period for that month if you miss more than one dose or change your schedule.

You could have light bleeding or spotting if you do not take a pill on time. The more pills you miss, the more likely you are to have bleeding.

Make sure your doctor knows if you miss your period 2 months in a row, because this could mean that you are pregnant.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions while using Junel 1.5/30

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often. Your doctor may also want to check your blood pressure while taking this medicine.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Make sure your doctor knows if you had given birth within 4 weeks before you start using this medicine.

Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier.

• If this should occur, continue with your regular dosing schedule.
• The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week.
• If the bleeding continues after you have been taking hormonal contraceptives on schedule and for more than 3 months, check with your doctor.

Check with your doctor right away if you missed a menstrual period. Missed periods may occur if you skip one or more tablets and have not taken your pills exactly as directed. If you miss two periods in a row, call your doctor for a pregnancy test before you take any more pills.

If you suspect that you may be pregnant, check with your doctor right away.

Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using norethindrone and ethinyl estradiol combination, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Using this medicine may increase your risk of having blood clotting problems. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, unexplained shortness of breath, a sudden loss of coordination, or vision changes while using this medicine.

Using this medicine may increase your risk of having cancer of the breast or your reproductive organs (eg, endometrium, ovaries, cervix). Talk with your doctor about this risk. Check with your doctor immediately if your experience abnormal vaginal bleeding.

Check with your doctor immediately if you wear contact lenses or if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want an eye doctor (ophthalmologist) to check your eyes.

Check with your doctor right away if you have pain or tenderness in the upper stomach, dark urine or pale stools, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may increase your risk of having gallbladder disease. Check with your doctor if you start to have stomach pains, nausea, and vomiting.

Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.

Make sure any doctor or dentist who treats you knows that you are using this medicine. The results of some medical tests may be affected by this medicine. You may also need to stop using this medicine at least 4 weeks before and 2 weeks after having major surgery.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John’s wort) or vitamin supplements.

Side Effects of Junel 1.5/30

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Absent, missed, or irregular menstrual periods
• anxiety
• change in vision
• changes in skin color
• chest pain or discomfort
• chills
• clay-colored stools
• constipation
• cough
• dark urine
• diarrhea
• dizziness or lightheadedness
• fainting
• fast heartbeat
• fever
• headache
• hives or welts
• itching skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• medium to heavy, irregular vaginal bleeding between regular monthly periods, which may require the use of a pad or a tampon
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• pain, tenderness, or swelling of the foot or leg
• pains in the chest, groin, or legs, especially in the calves of the legs
• pounding in the ears
• rash
• redness of the skin
• severe headaches of sudden onset
• slow or fast heartbeat
• stomach pain
• sudden loss of coordination or slurred speech
• sweating
• troubled breathing
• unusual tiredness or weakness
• vomiting
• vomiting of blood

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Bloating
• blotchy spots on the exposed skin
• breast enlargement or tenderness
• discouragement
• feeling sad or empty
• irritability
• itching of the vagina or outside genitals
• loss of interest or pleasure
• pain during sexual intercourse
• stomach cramps
• thick, white curd-like vaginal discharge without odor or with mild odor
• tiredness
• trouble concentrating
• trouble sleeping
• trouble wearing contact lenses

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA .

Commonly used brand name(s)

In the U.S.

• Femhrt 1/5
• Femhrt Lo
• Gildess 1.5/30
• Jevantique
• Jinteli
• Junel 1/20
• Junel 1.5/30
• Larin 1/20
• Loestrin 1/20
• Loestrin 1.5/30
• Microgestin 1/20
• Microgestin 1.5/30

Available Dosage Forms:

• Tablet, Chewable
• Tablet
• Capsule, Liquid Filled

Oral route(Tablet)

Junel(R): Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including Junel, are contraindicated in women who are over 35 years of age and smoke .Microgestin(R): Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

Uses for Junel 1/20

Ethinyl estradiol and norethindrone combination is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, ethinyl estradiol and norethindrone, and when taken properly, prevents pregnancy. It works by stopping a woman’s egg from fully developing each month. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented.

No contraceptive method is 100 percent effective. Birth control methods, such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.

This medicine does not prevent HIV infection or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

This medicine is available only with your doctor’s prescription.

Before using Junel 1/20

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of ethinyl estradiol and norethindrone combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.

Geriatric

No information is available on the relationship of age to the effects of ethinyl estradiol and norethindrone combination in the geriatric patients.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amifampridine
• Amobarbital
• Amoxicillin
• Ampicillin
• Amprenavir
• Anagrelide
• Apalutamide
• Aprepitant
• Armodafinil
• Artemether
• Bacampicillin
• Belzutifan
• Betamethasone
• Bexarotene
• Boceprevir
• Bosentan
• Bupropion
• Butabarbital
• Butalbital
• Carbamazepine
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixime
• Cefpodoxime
• Cefprozil
• Ceftazidime
• Ceftibuten
• Cefuroxime
• Cenobamate
• Ceritinib
• Clobazam
• Cloxacillin
• Cobicistat
• Colesevelam
• Cyclacillin
• Cyclosporine
• Dabrafenib
• Darunavir
• Dexamethasone
• Dicloxacillin
• Dipyrone
• Donepezil
• Doxycycline
• Efavirenz
• Elagolix
• Elvitegravir
• Encorafenib
• Enzalutamide
• Eslicarbazepine Acetate
• Etravirine
• Felbamate
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Fostemsavir
• Glecaprevir
• Grazoprevir
• Griseofulvin
• Guar Gum
• Indinavir
• Iron
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lixisenatide
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mephobarbital
• Meropenem
• Methohexital
• Minocycline
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafcillin
• Nelfinavir
• Nevirapine
• Nirmatrelvir
• Octreotide
• Oxacillin
• Oxcarbazepine
• Oxytetracycline
• Paclitaxel
• Paclitaxel Protein-Bound
• Penicillin G
• Penicillin G Procaine
• Penicillin V
• Pentobarbital
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pibrentasvir
• Piperaquine
• Pitolisant
• Prednisolone
• Prednisone
• Primidone
• Red Clover
• Rifabutin
• Rifampin
• Rifapentine
• Rilpivirine
• Ritonavir
• Rufinamide
• Saquinavir
• Secobarbital
• Simeprevir
• Somatrogon-ghla
• St John’s Wort
• Sugammadex
• Sultamicillin
• Tazemetostat
• Telaprevir
• Telotristat Ethyl
• Tetracycline
• Theophylline
• Thiopental
• Thioridazine
• Ticarcillin
• Tigecycline
• Tipranavir
• Tirzepatide
• Tizanidine
• Topiramate
• Troglitazone
• Ulipristal
• Valproic Acid
• Voxilaprevir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amitriptyline
• Atazanavir
• Atorvastatin
• Clomipramine
• Diazepam
• Doxepin
• Etoricoxib
• Ginseng
• Imipramine
• Lamotrigine
• Levothyroxine
• Licorice
• Liothyronine
• Lorazepam
• Parecoxib
• Roflumilast
• Selegiline
• Temazepam
• Tipranavir
• Triazolam
• Troleandomycin
• Valdecoxib
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (eg, deep vein thrombosis, pulmonary embolism), or history of or
• Breast cancer, known or suspected or
• Diabetes with kidney, eye, nerve, or blood vessel damage or
• Endometrial cancer or
• Heart attack, history of or
• Heart or blood vessel disease (eg, coronary artery disease, heart valve problems), or history of or
• Hypertension (high blood pressure) that is not under good control, or
• Jaundice during pregnancy or from using hormonal therapy in the past or
• Liver disease, including tumors or cancer or
• Major surgery with prolonged periods of immobilization or
• Migraine headache or
• Stroke, history of or
• Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.

• Breast cancer, family history of or
• Cervical cancer or
• Depression, history of or
• Edema (fluid retention or body swelling) or
• Epilepsy (seizures) or
• Gallbladder disease or
• Hypertension (high blood pressure)—Use with caution. May make these conditions worse.

• Diabetes or
• Hyperlipidemia (high cholesterol or fats in the blood) or
• Kidney disease or
• Obesity, or history of—Use with caution. These conditions may increase risk for more serious side effects.

Proper use of Junel 1/20

It is very important that you use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

To make using oral contraceptives as safe and reliable as possible, you should understand how and when to take them and what effects may be expected.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine is available in blister packs with a Dialpak® tablet dispenser. Each blister pack contains 28 tablets with different colors that need to be taken in the same order as directed on the blister pack.

When you begin using this medicine, your body will require at least 7 days to adjust before a pregnancy will be prevented. Use a second form of contraception, such as a condom, spermicide, or diaphragm, for the first 7 days of your first cycle of pills.

Take this medicine at the same time each day (with meals or at bedtime). Birth control pills work best when no more than 24 hours pass between doses.

Do not skip or delay taking your pill by more than 24 hours. If you miss a dose, you could get pregnant. Ask your doctor for ways to help you remember to take your pills or about using another method of birth control.

You may feel sick or nauseated, especially during the first few months that you take this medicine. If your nausea is continuous and does not go away, call your doctor.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 start) or on the first Sunday after your menstrual period starts (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even if you miss a dose. Do not change your schedule on your own. If the schedule that you use is not convenient, check with your doctor about changing it. For a Sunday start, you need to use another form of birth control (eg, condom, diaphragm, spermicide) for the first 7 days.

You should begin your next and all subsequent 28-day regimens of therapy on the same day of the week as the first regimen began and follow the same schedule.

• For oral dosage form (tablets):
  • For contraception (to prevent pregnancy):
    • Adults and teenagers—
      • Loestrin® 21: One white or green tablet (active) taken at the same time each day for 21 consecutive days followed by one week without the tablets.
      • Loestrin® Fe: One white or green tablet (active) taken at the same time each day for 21 consecutive days followed by one brown (inert) tablet daily for 7 days per menstrual cycle.
      • Modicon®: One white tablet (active) taken at the same time each day for 21 consecutive days followed by one green (inert) tablet daily for 7 days per menstrual cycle.
      • Ortho-novum®: One white or peach tablet (active) taken at the same time each day for 21 consecutive days followed by one green (inert) tablet daily for 7 days per menstrual cycle.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

This medicine has specific patient instructions on what to do if you miss a dose. Read and follow these instructions carefully and call your doctor if you have any questions.

• If you miss one active pill: Take it as soon as you can, then take your next pill at your regular schedule.
• If you miss two active pills in week 1 or 2: Take two pills as soon as you can and two more pills the next day. Continue taking one pill a day until you finish the pack. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose.
• If you miss two active pills in week 3, or you miss three or more active pills in a row in weeks 1, 2, or 3:
  • Day 1 start: Throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose.
  • Sunday start: Continue taking one pill a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy.

You may not have a period for that month if you miss more than one dose or change your schedule.

You could have light bleeding or spotting if you do not take a pill on time. The more pills you miss, the more likely you are to have bleeding.

Make sure your doctor knows if you miss your period 2 months in a row, because this could mean that you are pregnant.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions while using Junel 1/20

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often. Your doctor may also want to check your blood pressure while taking this medicine.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Make sure your doctor knows if you had given birth within 4 weeks before you start using this medicine.

Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier.

• If this should occur, continue with your regular dosing schedule.
• The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week.
• If the bleeding continues after you have been taking hormonal contraceptives on schedule and for more than 3 months, check with your doctor.

Check with your doctor right away if you missed a menstrual period. Missed periods may occur if you skip one or more tablets and have not taken your pills exactly as directed. If you miss two periods in a row, call your doctor for a pregnancy test before you take any more pills.

If you suspect that you may be pregnant, check with your doctor right away.

Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using norethindrone and ethinyl estradiol combination, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Using this medicine may increase your risk of having blood clotting problems. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, unexplained shortness of breath, a sudden loss of coordination, or vision changes while using this medicine.

Using this medicine may increase your risk of having cancer of the breast or your reproductive organs (eg, endometrium, ovaries, cervix). Talk with your doctor about this risk. Check with your doctor immediately if your experience abnormal vaginal bleeding.

Check with your doctor immediately if you wear contact lenses or if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want an eye doctor (ophthalmologist) to check your eyes.

Check with your doctor right away if you have pain or tenderness in the upper stomach, dark urine or pale stools, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may increase your risk of having gallbladder disease. Check with your doctor if you start to have stomach pains, nausea, and vomiting.

Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.

Make sure any doctor or dentist who treats you knows that you are using this medicine. The results of some medical tests may be affected by this medicine. You may also need to stop using this medicine at least 4 weeks before and 2 weeks after having major surgery.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John’s wort) or vitamin supplements.

Side Effects of Junel 1/20

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Absent, missed, or irregular menstrual periods
• anxiety
• change in vision
• changes in skin color
• chest pain or discomfort
• chills
• clay-colored stools
• constipation
• cough
• dark urine
• diarrhea
• dizziness or lightheadedness
• fainting
• fast heartbeat
• fever
• headache
• hives or welts
• itching skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• medium to heavy, irregular vaginal bleeding between regular monthly periods, which may require the use of a pad or a tampon
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• pain, tenderness, or swelling of the foot or leg
• pains in the chest, groin, or legs, especially in the calves of the legs
• pounding in the ears
• rash
• redness of the skin
• severe headaches of sudden onset
• slow or fast heartbeat
• stomach pain
• sudden loss of coordination or slurred speech
• sweating
• troubled breathing
• unusual tiredness or weakness
• vomiting
• vomiting of blood

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Bloating
• blotchy spots on the exposed skin
• breast enlargement or tenderness
• discouragement
• feeling sad or empty
• irritability
• itching of the vagina or outside genitals
• loss of interest or pleasure
• pain during sexual intercourse
• stomach cramps
• thick, white curd-like vaginal discharge without odor or with mild odor
• tiredness
• trouble concentrating
• trouble sleeping
• trouble wearing contact lenses

What is Kariva?

Kariva is a combination birth control pill containing female hormones that prevent ovulation (the release of an egg from an ovary). Kariva also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Kariva is used to prevent pregnancy. There are many brands of this medicine available. Not all brands are listed on this leaflet.

Kariva may also be used for purposes not listed in this medication guide.

Birth control pills side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Birth control pills may cause serious side effects. Stop using birth control pills and call your doctor at once if you have:

• signs of a stroke–sudden numbness or weakness, severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot in the lung–chest pain, sudden cough or shortness of breath, dizziness, coughing up blood;
• signs of a blood clot deep in the body–pain, swelling, or warmth in one leg;
• heart attack symptoms–chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems–swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• increased blood pressure–severe headache, blurred vision, pounding in your neck or ears;
• depression–mood changes, feelings of low self-worth, loss of interest in things you once enjoyed, new sleep problems, thoughts about hurting yourself;
• swelling in your hands, ankles, or feet, or a breast lump; or
• changes in the pattern or severity of migraine headaches.

Common side effects of Kariva may include:

• weight gain, nausea, vomiting, breast tenderness, or breakthrough bleeding;
• acne, darkening of facial skin; or
• problems with contact lenses.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Do not take birth control pills if you are pregnant or if you have recently had a baby.

You should not use birth control pills if you have: heart problems, circulation problems, undiagnosed vaginal bleeding, liver problems, severe migraine headaches, if you also take certain hepatitis C medication, if you will have major surgery, if you smoke and are over 35, or if you have ever had a heart attack, a stroke, a blood clot, jaundice caused by pregnancy or birth control pills, or cancer of the breast, uterus/cervix, or vagina.

Before taking this medicine

Taking birth control pills can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of taking birth control pills. Your risk is also high when you restart birth control pills after not taking them for 4 weeks or longer.

Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills, especially if you are older than 35.

Do not use if you are pregnant. Stop using Kariva and tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills.

You should not take birth control pills if you have:

• untreated or uncontrolled high blood pressure, or heart disease (chest pain, coronary artery disease, history of heart attack, stroke, circulation problems, or blood clot) or an increased risk of having blood clots due to a heart problem or a hereditary blood disorder;
• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina;
• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease or liver cancer, if you take any hepatitis C medication containing ombitasvir/paritaprevir/ritonavir with or without dasabuvir or if you have a history of jaundice caused by pregnancy or birth control pills; or
• severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35 or if you smoke and are over 35 years old.

Tell your doctor if you have ever had:

• heart disease, high blood pressure, varicose veins, if you are prone to having blood clots, high cholesterol or triglycerides, or if you are overweight;
• depression, migraine headaches, diabetes, gallbladder disease;
• liver or kidney disease; or
• irregular menstrual cycles, fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

Ask a doctor if it is safe to breastfeed while using this medicine.

How should I take birth control pills?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You will take your first pill on the first day of your period or on the first Sunday after your period begins. You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medicine. Follow your doctor’s instructions.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not take one pill daily. Get your prescription refilled before you run out of pills completely.

Some birth control packs contain seven “reminder” pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding. Tell your doctor if it continues or is very heavy.

Use a back-up birth control if you are sick with severe vomiting or diarrhea.

Any doctor or surgeon who treats you should know that you are using birth control pills.

While taking birth control pills, you will need to visit your doctor regularly.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Follow the directions on your prescription label and read all medication guides or instruction sheets. Missing a pill increases your risk of becoming pregnant.

If you miss 1 active pill, take two pills on the day you remember. Then take one pill per day for the rest of the pack.

If you miss 2 active pills in a row in Week 1 or 2, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss 2 active pills in a row in Week 3, throw out the rest of the pack and start a new pack the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day.

If you miss 3 active pills in a row in Week 1, 2, or 3, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss a reminder pill, throw it away and keep taking one reminder pill per day until the pack is empty.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking birth control pills?

Do not smoke while taking birth control pills, especially if you are older than 35 years of age.

Using birth control pills will not prevent your disease from spreading. Ask your doctor how to prevent HIV transmission during sex.

What is Kurvelo?

Kurvelo is used as contraception to prevent pregnancy. There are many brands and forms of this medicine available. Not all brands are listed on this leaflet.

Kurvelo may also be used for purposes not listed in this medication guide.

Kurvelo side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Birth control pills may cause serious side effects. Stop using birth control pills and call your doctor at once if you have:

• signs of a stroke–sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems;
• signs of a blood clot–sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, swelling or redness in an arm or leg;
• heart attack symptoms–chest pain or pressure, pain spreading to your jaw or shoulder, sweating;
• liver problems–loss of appetite, upper stomach pain, tiredness, fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• increased blood pressure–severe headache, blurred vision, pounding in your neck or ears;
• gallbladder problem–chalky-colored stools, stomach pain after eating, nausea, heartburn, bloating, and severe upper stomach pain that may spread to your back;
• swelling in your hands, ankles, or feet;
• changes in the pattern or severity of migraine headaches;
• a breast lump; or
• symptoms of depression–sleep problems, weakness, tired feeling, mood changes.

Common side effects of Kurvelo may include:

• nausea, vomiting (especially when you first start taking this medicine);
• breast tenderness;
• breakthrough bleeding;
• acne, darkening of facial skin;
• weight gain; or
• problems with contact lenses.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Do not use birth control pills if you are pregnant or if you have recently had a baby.

You should not use birth control pills if you have: uncontrolled high blood pressure, heart disease, coronary artery disease, circulation problems (especially with diabetes), undiagnosed vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you also take certain hepatitis C medication, if you will have major surgery, if you smoke and are over 35, or if you have ever had a heart attack, a stroke, a blood clot, jaundice caused by pregnancy or birth control pills, or cancer of the breast, uterus/cervix, or vagina.

Taking birth control pills can increase your risk of blood clots, stroke, or heart attack.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not take this medicine if you smoke and are over 35 years old.

Before taking this medicine

Taking this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of taking birth control pills. Your risk is also high when you restart this medicine after not taking it for 4 weeks or longer.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not take combination birth control pills if you smoke and are over 35 years old.

Do not use if you are pregnant. Stop using this medicine and tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills.

You should not take birth control pills if you have:

• untreated or uncontrolled high blood pressure;
• heart disease (chest pain, coronary artery disease, history of heart attack, stroke, or blood clot);
• an increased risk of having blood clots due to a heart problem or a hereditary blood disorder;
• circulation problems (especially if caused by diabetes);
• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina;
• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease or liver cancer;
• severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35;
• a history of jaundice caused by pregnancy or birth control pills; or
• if you take any hepatitis C medication containing ombitasvir/paritaprevir/ritonavir (Technivie).

Tell your doctor if you have ever had:

• heart disease, high blood pressure, or if you are prone to having blood clots;
• high cholesterol or triglycerides, or if you are overweight;
• depression;
• a seizure or migraine headache;
• diabetes, gallbladder disease;
• liver or kidney disease;
• irregular menstrual cycles; or
• fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

Kurvelo can slow breast milk production. You should not breastfeed while using this medicine.

How should I take Kurvelo?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take your first pill on the first day of your period or on the first Sunday after your period begins. You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medicine. Follow your doctor’s instructions.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not take one pill daily. Get your prescription refilled before you run out of pills completely.

Some birth control packs contain seven “reminder” pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You should chew the chewable tablet (pill) and then swallow it with a glass of water, or if you prefer you should swallow the chewable tablet (pill) whole. Take it on an empty stomach.

Use a back-up birth control if you are sick with severe vomiting or diarrhea.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

While taking birth control pills, you will need to visit your doctor regularly.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Follow the patient instructions provided with your medicine. Missing a pill increases your risk of becoming pregnant.

If you miss one active pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two active pills in a row in Week 1 or 2, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two active pills in a row in Week 3, throw out the rest of the pack and start a new pack the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day.

If you miss three active pills in a row in Week 1, 2, or 3, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day.

If you miss two or more active pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

What is Kyleena?

Kyleena contains levonorgestrel, a female hormone that can cause changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

The Kyleena levonorgestrel-releasing intrauterine system is a small, flexible plastic T-shaped device containing 19.5 mg levonorgestrel. The Kyleena intrauterine device (IUD) is placed in the uterus where it slowly releases the hormone. Because the IUD releases levonorgestrel into your uterus, only small amounts of the hormone enter your blood. Kyleena does not contain estrogen and should not be used as emergency birth control.

The Kyleena IUD is placed in your uterus by your healthcare provider to prevent pregnancy for up to 5 years. The IUD can be removed by your healthcare provider at any time. Kleena can be used whether or not you have given birth to a child.

Two thin threads are attached to the stem (lower end) of Kyleena. The threads are the only part of Kyleena you can feel when the IUD is in your uterus; however, unlike a tampon string, the threads do not extend outside your body.

Warnings

You should not use the Kyleena IUD if you have abnormal vaginal bleeding, a pelvic infection, certain other problems with your uterus or cervix, or if you have breast or uterine cancer, liver disease or liver tumor, or a weak immune system.

Do not use Kyleena during pregnancy. Call your doctor if you think you might be pregnant.

Kyleena does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs).

Call your doctor at once if you have symptoms of a stroke or heart attack, such as sudden numbness or weakness, severe headache, or chest pain.

Before taking this medicine

Kyleena can increase your risk of developing a serious pelvic infection, which may threaten your life or your future ability to have children. Ask your doctor about this risk.

Do not use Kyleena during pregnancy. If left in place during pregnancy, the IUD could cause severe infection, miscarriage, premature birth, or death of the mother. The hormone in Kyleena may also cause unwanted effects in a female newborn.

Tell your doctor right away if you become pregnant. If you continue the pregnancy, watch for signs such as fever, chills, cramps, vaginal bleeding or discharge.

You should not use Kyleena if you are allergic to levonorgestrel, silicone, silica, silver, barium, iron oxide, or polyethylene, or if you have:

• abnormal vaginal bleeding that has not been checked by a doctor;
• an untreated or uncontrolled pelvic infection (vaginal, cervical, uterine);
• endometriosis or a serious pelvic infection following a pregnancy or abortion in the past 3 months;
• pelvic inflammatory disease (PID), unless you had a normal pregnancy after the infection was treated and cleared;
• uterine fibroid tumors or conditions that affect the shape of the uterus;
• past or present cancer of the breast, cervix, or uterus;
• liver disease or liver tumor (benign or malignant);
• a condition that weakens your immune system, such as AIDS, leukemia, or IV drug abuse;
• if you have another intrauterine device (IUD) in place;
• if you had an abortion or miscarriage in the past 6 weeks; or
• if you gave birth to a baby in the past 6 weeks.

Tell your doctor if you have ever had:

• high blood pressure, heart problems, a heart attack, or a stroke;
• bleeding problems;
• migraine headaches; or
• a vaginal infection, pelvic infection, or sexually transmitted disease.

You may use Kyleena when you are breastfeeding. Levonorgestrel is not likely to affect the quality or amount of your breast milk or the health of your nursing baby. However, isolated cases of decreased milk production have been reported. The risk of uterine complications from insertion of the Kyleena IUD is greater while you are breastfeeding.

How is Kyleena used?

Kyleena is inserted through the vagina and placed into the uterus by a doctor.

You may feel pain or dizziness during insertion of the Kyleena IUD, and you may have minor vaginal bleeding. Tell your doctor if these symptoms last longer than 30 minutes.

The Kyleena IUD should not interfere with sexual intercourse, wearing a tampon or menstrual cup, or using other vaginal medications.

Your doctor should check the IUD after a few weeks to make sure it is still in place. You will also need annual pelvic exams and Pap smears.

You may have irregular periods for 3 to 6 months. Your flow may be lighter or heavier, and your periods may stop after several months. Tell your doctor if you do not have a period for 6 weeks or if you think you might be pregnant.

The Kyleena IUD may come out by itself. After each menstrual period, make sure you can still feel the removal strings at the opening of your cervix.

Call your doctor at once if you cannot feel the strings, or if you think the IUD has slipped lower or has come out of your uterus, especially if you also have pain or bleeding. Use a non-hormone method of birth control (condom, diaphragm, cervical cap, or contraceptive sponge) to prevent pregnancy until your doctor is able to replace the IUD.

If you need to have an MRI (magnetic resonance imaging), tell your caregivers ahead of time that you have a Kyleena IUD in place.

Your IUD may be removed at any time you decide to stop using birth control.Kyleena must be removed after 5 yearss. Your doctor can insert a new device if you wish to continue using this form of birth control. Only your doctor should remove the IUD. Do not attempt to remove the Kyleena IUD yourself.

If you decide to use a different method of birth control, you may need to start using it a week before your IUD is removed.

Dosing information

Usual Adult Dose for Contraception:

Intrauterine Device insertion should be performed by a trained healthcare provider thoroughly familiar with product; product manufacturer labeling should be consulted:

Insert 1 Kyleena IUD into uterus

Timing of insertion:
-For women who are not currently using hormonal or intrauterine contraception: Insertion may occur at any time the woman is not pregnant; if inserted after the first 7 days of menstrual cycle, an additional method of contraception should be used for 7 days after insertion
-Switching from an oral, transdermal, or vaginal hormonal contraceptive: Insertion may occur at any time; if inserted during the hormone phase, continue use for 7 days after insertion or until the end of the current treatment cycle
-Switching from an injectable progestin contraceptive: Insertion may occur at any time; if inserted more than 3 months after the last injection, an additional method of contraception should be used for 7 days after insertion
-Switching from a contraceptive implant or another IUD: Insertion should occur on the same day the implant or IUD is removed
-Inserting after abortion or miscarriage:
–First trimester: May insert IUD immediately after a first trimester abortion or miscarriage
–Second trimester: Insertion of IUD should be delayed a minimum of 4 weeks or until the uterus is fully involuted; if involution is delayed, insertion should be delayed until involution is complete; consider the possibility of ovulation and conception occurring prior to insertion and advise patient on need for an additional method of contraception for 7 days after insertion
-After childbirth: Insertion of IUD should be delayed a minimum of 4 weeks after delivery, or until the uterus is fully involuted; if involution is delayed, insertion should be delayed until involution is complete; consider the possibility of ovulation and conception occurring prior to insertion and advise patient on need for an additional method of contraception for 7 days after insertion

Replacement: IUD should be replaced after 5 years; a new IUD may be inserted for continued use.
Comments:
-IUD may be removed at any time but must be removed by the end of 5 years; if continued use is desired, replace with a new IUD.

What happens if I miss a dose?

Since the Kyleena IUD continuously releases a low dose of levonorgestrel, missing a dose does not occur when using this form of levonorgestrel.

What happens if I overdose?

An overdose of levonorgestrel released from the intrauterine system is very unlikely to occur.

What should I avoid while using Kyleena?

Avoid having more than one sex partner. The IUD can increase your risk of developing a serious pelvic infection, which is often caused by sexually transmitted disease. Kyleena will not protect you from sexually transmitted diseases, including HIV and AIDS. Using a condom may help protect yourself from these diseases.

Call your doctor if your sex partner develops HIV or a sexually transmitted disease, or if you have any change in sexual relationships.

Kyleena side effects

Get emergency medical help if you have signs of an allergic reaction to Kyleena: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have severe pain in your lower stomach or side. This could be a sign of a tubal pregnancy.

The Kyleena IUD may become embedded into the wall of the uterus, or may perforate (form a hole) in the uterus. If this occurs, the device may no longer prevent pregnancy, or it may move outside the uterus and cause scarring, infection, or damage to other organs. Your doctor may need to surgically remove the device.

Call your doctor at once if you have:

• severe cramps or pelvic pain, pain during sexual intercourse;
• extreme dizziness or light-headed feeling;
• severe migraine headache;
• heavy or ongoing vaginal bleeding, vaginal sores, vaginal discharge that is watery, foul-smelling discharge, or otherwise unusual;
• pale skin, weakness, easy bruising or bleeding, fever, chills, or other signs of infection;
• jaundice (yellowing of the skin or eyes); or
• sudden numbness or weakness (especially on one side of the body), confusion, problems with vision, sensitivity to light.

Common Kyleena side effects may include:

• pelvic pain, painful or irregular menstrual periods, changes in bleeding patterns or flow;
• vaginal swelling, itching or infection;
• temporary pain, bleeding, or dizziness during insertion of the IUD;
• ovarian cysts (pelvic pain that disappears within 3 months);
• stomach pain, nausea, vomiting, bloating;
• headache, migraine, depression, mood changes;
• back pain, breast tenderness or pain;
• weight gain, acne, oily skin, changes in hair growth, loss of interest in sex; or
• puffiness in your face, hands, ankles, or feet.

What is Liletta?

Liletta (levonorgestrel) is an intrauterine device (IUD) used to prevent pregnancy and also to treat heavy periods (menstrual bleeding).  Liletta is an IUD which is a small, flexible, T-shaped plastic device that is placed in the uterus, where it slowly releases the hormone levonorgestrel.  

The Liletta IUD works to prevent pregnancy by thickening the mucus at the entrance to the uterus to prevent sperm from entering, thinning the lining of the uterus, and preventing sperm from moving and surviving in the uterus. Liletta works to treat heavy periods by levonorgestrel effect on the uterus. Liletta works to treat heavy periods by controlling the monthly development of the uterus lining so there is less bleeding each month.

Liletta contains levonorgestrel which is a progestin hormone; it does not contain estrogen. It should not be used as emergency birth control and does not protect you from sexually transmitted infections or human immunodeficiency virus (HIV).

How long does Liletta IUD last?

Liletta can be used for up to 8 years to prevent pregnancy and for 5 years when used for heavy periods and as a contraceptive. It can be replaced at the time of removal with a new device if continued contraceptive protection is wanted. You can stop using the IUD at any time by asking your healthcare provider to remove it.

When does Liletta start working?

If you are currently not using hormonal or intrauterine contraception:

• Liletta IUD will start working immediately as a contraceptive if it is inserted within the first seven days of your period or immediately after a first-trimester abortion or miscarriage. However, if you choose to have Liletta inserted at any other time during your monthly cycle, you will need to use an additional birth control method (like condoms) for the first week, as at this stage of your cycle, it takes seven days after the insertion of Liletta for it to provide full protection against pregnancy.

For information on when Liletta starts working when switching from oral, transdermal, vaginal hormonal contraceptive or injectable progestin contraceptive, see the dosing information link below.

How well does Liletta work?

Liletta IUD is very effective at preventing pregnancy with a low chance of becoming pregnant, with less than 1 in 100 patients becoming pregnant in one year.

Liletta IUD works well to reduce heavy menstrual bleeding with 80% of patients having their blood loss reduced by half after 6 months.

Liletta side effects

Common Liletta side effects may include:

• pelvic pain, painful or irregular menstrual periods, changes in bleeding patterns or flow;
• vaginal swelling, itching or infection;
• temporary pain, bleeding, or dizziness during insertion of the IUD;
• ovarian cysts (pelvic pain that disappears within 3 months);
• stomach pain, nausea, vomiting, bloating;
• headache, migraine, depression, mood changes;
• back pain, breast tenderness or pain;
• weight gain, acne, oily skin, changes in hair growth, loss of interest in sex; or
• puffiness in your face, hands, ankles, or feet.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have severe pain in your lower stomach or side. This could be a sign of a tubal pregnancy.

The IUD may become embedded into the wall of the uterus, or may perforate (form a hole) in the uterus. If this occurs, the device may no longer prevent pregnancy, or it may move outside the uterus and cause scarring, infection, or damage to other organs. Your doctor may need to surgically remove the device.

Serious Liletta side effects may include:

Call your doctor at once if you have:

• severe cramps or pelvic pain, pain during sexual intercourse;
• extreme dizziness or light-headed feeling;
• severe migraine headache;
• heavy or ongoing vaginal bleeding, vaginal sores, vaginal discharge that is watery, foul-smelling discharge, or otherwise unusual;
• pale skin, weakness, easy bruising or bleeding, fever, chills, or other signs of infection;
• jaundice (yellowing of the skin or eyes); or
• sudden numbness or weakness (especially on one side of the body), confusion, problems with vision, sensitivity to light.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Do not use Liletta during pregnancy. Tell your doctor right away if you become pregnant.

Before using this medicine

An IUD can increase your risk of developing a serious pelvic infection, which may threaten your life or your future ability to have children. Ask your doctor about this risk.

You should not use Liletta if you are allergic to levonorgestrel, or other materials in this device. For a full list of ingredients, click here Liletta ingredients.

You should not use Liletta if you have:

• abnormal vaginal bleeding that has not been checked by a doctor;
• an untreated or uncontrolled pelvic infection (vaginal, cervical, uterine);
• endometriosis or a serious pelvic infection following a pregnancy or abortion in the past 3 months;
• pelvic inflammatory disease (PID), unless you had a normal pregnancy after the infection was treated and cleared;
• uterine fibroid tumors or conditions that affect the shape of the uterus;
• past or present cancer of the breast, cervix, or uterus;
• liver disease or liver tumor (benign or malignant);
• a condition that weakens your immune system, such as AIDS, leukemia, or IV drug abuse;
• if you have another intrauterine device (IUD) in place;
• if you had an abortion or miscarriage in the past 6 weeks; or
• if you gave birth to a baby in the past 6 weeks.

Tell your doctor if you have ever had:

• high blood pressure, heart problems, a heart attack, or a stroke;
• bleeding problems;
• migraine headaches; or
• a vaginal infection, pelvic infection, or sexually transmitted disease.

Pregnancy

Do not use during pregnancy. If left in place during pregnancy, Liletta could cause severe infection, miscarriage, premature birth, or death of the mother. The hormone Liletta may also cause unwanted effects in a female newborn.

Tell your doctor right away if you become pregnant. If you continue the pregnancy, watch for signs such as fever, chills, cramps, vaginal bleeding, or discharge.

Breastfeeding

Tell your doctor if you are breastfeeding. You may use Liletta when breastfeeding as it is not likely to affect the quality or amount of breast milk; however, a small number of patients who have taken progestin-only birth control pills report a decrease in the amount of milk produced. There is also an increased risk of Liletta becoming attached or going through the wall of the uterus when breastfeeding.

How is Liletta used?

The Liletta IUD is inserted through the vagina and placed into the uterus by a healthcare professional. You may feel pain or dizziness during insertion of the IUD, and you may have minor vaginal bleeding. Tell your doctor if these symptoms last longer than 30 minutes.

Your doctor should check Liletta after a few weeks to make sure it is still in place. You will also need annual pelvic exams and Pap smears.

Liletta should not interfere with sexual intercourse, wearing a tampon or menstrual cup, or using other vaginal medications.

The IUD may come out by itself. After each menstrual period, make sure you can still feel the removal threads at the opening of your cervix. At the lower end of the Liletta device, there are two treads which are the only part of the device that you can feel when the IUD is in your uterus; however, unlike a tampon string, the threads do not extend outside your body.

Call your doctor at once if you cannot feel the strings or if you think Liletta has slipped lower or has come out of your uterus, especially if you also have pain or bleeding. Use a non-hormone method of birth control (condom, diaphragm, cervical cap, or contraceptive sponge) to prevent pregnancy until your doctor is able to replace the IUD.

You may have irregular periods for 3 to 6 months. Your flow may be lighter or heavier, and your periods may stop after several months. Tell your doctor if you do not have a period for 6 weeks or if you think you might be pregnant.

If you need to have an MRI (magnetic resonance imaging), tell your healthcare providers ahead of time that you have an IUD in place.

Liletta may be removed at any time you decide to stop using birth control. Liletta must be removed at the end of the 8-year wearing time when used as a contraceptive and for 5 years when used for heavy periods and as a contraceptive. 

If you decide to use a different method of birth control, you may need to start using it a week before Liletta is removed.

Only your doctor should remove the IUD. Do not attempt to remove the device yourself.

Dosing information

Liletta contains levonorgestrel 52 mg, which initially has a release rate of 20 mcg/day and declines to 6.5 mcg/day after 8 years. The average release rate of levonorgestrel is approximately 13.5 mcg/day over a period of 8 years. The T-shaped plastic frame is 32mm by 32 mm.

Liletta should be removed at the end of the 8-year wearing time when used as a contraceptive and for 5 years when used for heavy periods and as a contraceptive. It can be replaced at the time of removal with a new device if continued contraceptive protection is wanted.

If pregnancy is not desired, Liletta can be removed at any time; however, another contraception method should be started at least 7 days before removal of the device. There is a risk of pregnancy if there has been intercourse in the week prior to removal without the use of a backup contraceptive method. 

What happens if I miss a dose?

Since the IUD continuously releases a low dose of levonorgestrel, missing a dose does not occur when using this form of levonorgestrel.

What happens if I overdose?

An overdose of levonorgestrel released from the intrauterine system is very unlikely to occur.

What should I avoid while using Liletta?

The IUD can increase your risk of developing a serious pelvic infection, which is often caused by sexually transmitted diseases. Liletta will not protect you from sexually transmitted diseases, including HIV and AIDS. Using a condom may help protect from these diseases.

Call your doctor if your sex partner develops HIV or a sexually transmitted disease, or if you have any change in sexual relationships.

What is Lo Loestrin FE?

Lo Loestrin Fe is a low-dose combination birth control pill (oral contraceptive) containing two different female hormones. It helps to prevent pregnancy.

Lo Loestrin Fe contains an estrogen called ethinyl estradiol and a progestin called norethindrone acetate. Lo Loestrin Fe works primarily by suppressing ovulation, which is when an egg is release from one of your ovaries each month. Combined birth control pills, such as this one, also work by thickening the mucus at the neck of the uterus (womb). This makes it harder for sperm to get through and reach an egg. They also thin the lining of the uterus, which reduces the chances of a fertilized egg implanting and growing.

Lo Loestrin Fe was approved for use by the US Food and Drug Administration (FDA) in 2010. A generic version of Lo Loestrin Fe has not been approved.

What is Lo Loestrin FE used for?

Lo Loestrin Fe is a  prescription medication used by women who want to prevent pregnancy.

Important information

Birth control pills help to lower the chances of becoming pregnant when taken as directed. They do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Do not skip any pills, even if you do not have sex often.

If you miss a period, you could be pregnant. However, some women miss periods or have light periods on birth control pills, even when they are not pregnant. Contact your healthcare provider for advice if you:

• Think you are pregnant
• Miss one period and have not taken your birth control pills every day
• Miss two periods in a row

You should stop Lo Loestrin Fe at least four weeks before you have surgery and not restart it until at least two weeks after the surgery, due to an increased risk of blood clots.

If you have vomiting or diarrhea, your birth control pills may not work as well. Use another birth control method, like a condom and spermicide, until you check with your healthcare provider.

If you are scheduled for any laboratory tests, tell your healthcare provider that you are taking birth control pills. Certain blood tests may be affected by birth control pills.

How well does Lo Loestrin Fe work?

Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant.

Based on the results of one clinical study, about 2 to 4 out of 100 women may get pregnant during the first year they use Lo Loestrin Fe.

Women with a BMI above 35 kg/m² were not studied in the clinical trial, so it is not known how well this medication protects against pregnancy in such women. If you are overweight, discuss with your healthcare provider whether Lo Loestrin Fe is the best choice for you.

Birth control pills are:

• Less effective than implants, injections, intrauterine devices and sterilization, which result in fewer than 1 pregnancy per 100 women in a year
• As effective as a skin patch or vagina ring with hormones
• Slightly more effective than condoms and diaphragms
• More effective than using spermicide, withdrawal or having no sex during the most fertile days of the monthly cycle, which result in 10 to 20 pregnancies per 100 women in one year
• More effective than no birth control, which results in 85 or more pregnancies per 100 women in one year

Who should not take Lo Loestrin FE?

Your healthcare provider will not give you Lo Loestrin Fe if you have:

• Ever had blood clots in your legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal thrombosis)
• Ever had a stroke
• Ever had a heart attack
• Certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart
• An inherited problem with your blood that makes it clot more than normal
• High blood pressure that medicine can’t control
• Diabetes with kidney, eye, nerve, or blood vessel damage
• Ever had certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision
• Ever had breast cancer, which may be sensitive to female hormones
• Liver disease, including liver tumors
• Take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme alanine aminotransferase (ALT) in the blood.

Also, do not take birth control pills if you:

• Smoke and are over 35 years old
• Are allergic to anything in this medication. See below for a complete list of ingredients.

Birth control pills may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy, also called cholestasis of pregnancy.

What should I tell my doctor before taking Lo Loestrin FE?

Before you take Lo Loestrin Fe, tell your healthcare provider about all of your medical conditions, including if you have ever had any of the conditions listed above in ‘Who should not take Lo Loestrin Fe?”.

How should I take Lo Loestrin FE?

• Take one pill every day at the same time. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant.
• You may have spotting or light bleeding, or may feel sick to your stomach during the first few months of taking this medication. If you have spotting or light bleeding or feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn’t go away, check with your healthcare provider.
• Missing pills can also cause spotting or light bleeding, even when you take these missed pills later. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.
• If you have trouble remembering to take this medication, talk to your healthcare provider about how to make pill-taking easier or about using another method of birth control.
• If you have vomiting or diarrhea (within 3 to 4 hours after you take your pill), you should follow the instructions for “What happens if I miss a dose”.
• If you have any questions or are unsure about the information in this leaflet, call your healthcare provider.

Before you start taking

1. Decide what time of day you want to take your pill. It is important to take it at the same time every day.

2. Look at your pill pack: The pill pack has 24 “active” blue pills (with hormones) and 2 “active” white pills (with hormones) for Weeks 1, 2, 3 and part of Week 4. The pill pack also has 2 “reminder” brown pills (without hormones) for the last part of Week 4.

3. Find:

• Where on the pack to start taking pills,
• In what order to take the pills (follow the arrows), and
• The week numbers as shown in the picture above

4. Have ready at all times:

• Another kind of birth control (such as a condom and spermicide) to use as a back-up in case you miss pills
• An extra pill pack

When to start the first pack

1. Take the day label strip that starts with the first day of your period. (This is the day you start bleeding or spotting, even if it is almost midnight when the bleeding begins.)

2. Place the day label strip on the tablet dispenser over the area that has the days of the week (starting with Sunday) printed on the plastic.

3. Take the first blue pill of the first pack during the first 24 hours of your period.

4. You will not need to use a back-up method of birth control, because you are starting the pill at the beginning of your period. However, if you start this medication later than the first day of your period, or if you start after having a baby and you have not yet resumed your periods, you should use another method of birth control (such as a condom and spermicide) as a back-up method until you have taken 7 blue pills.

When you switch from a different method of hormonal contraception

• When you switch from another birth control pill, start this medication on the first day you would have started your previous birth control pack.
• When you switch from a vaginal ring or skin patch, finish the 21 days of use, and wait 7 days after removal of the ring or patch before starting this medication.
• When you switch from a progestin-only pill, start Lo Loestrin Fe the next day.
• When you switch from an implant, start Lo Loestrin Fe on the day of implant removal.
• If you switch from an injectable contraceptive, start Lo Loestrin Fe on the day on which the next injection would be due.
• If you switch from an IUD, discuss with your healthcare provider when to start Lo Loestrin Fe.

What to do during the month

• Take one pill at the same time every day until the pack is empty.
  • Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach (nausea).
  • Do not skip pills even if you do not have sex very often.
• When you finish a pack of Lo Loestrin Fe, start the next pack on the day after your last brown “reminder” pill. Do not skip any days between packs.

What should I know about my period when taking?

When you take Lo Loestrin Fe you may have bleeding and spotting between periods, called unscheduled bleeding. Approximately half of the women who use this medication have unscheduled bleeding or spotting in the first months of use, and about one-third of users continue to have unscheduled bleeding or spotting after one year of use. If the unscheduled bleeding or spotting is heavy or lasts for more than a few days, you should discuss this with your healthcare provider.

What if I miss my scheduled period when taking?

It is not uncommon to miss your period. However, if you go two or more months in a row without a period, or you miss your period after a month where you did not take all your pills correctly, call your healthcare provider because you may be pregnant. Also notify your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. Stop taking Lo Loestrin Fe if you are pregnant.

What happens if I miss a dose?

Lo Loestrin Fe may not be as effective if you miss any blue or white pills, especially if you miss the first few or the last few blue pills in a pack.

If you miss ONE blue pill, follow these steps:

• Take it as soon as you remember. Take the next pill at your regular time. This means you may take two pills in 1 day.
• You do not need to use a back-up birth control method if you have sex.

If you miss TWO blue pills in a row in Week 1 or Week 2 of your pack, follow these steps:

• Take:
  • Two pills on the day you remember and two pills the next day.
  • Then one pill a day until you finish the pack.
• You could become pregnant if you have sex during the first 7 days after you restart your pills. You MUST use a non-hormonal birth control method (such as a condom and spermicide) as a back-up for those 7 days.

If you miss TWO pills (blue or white) in a row in Week 3 or Week 4 of your pack, follow these steps:

• Throw out the rest of the pill pack and start a new pack that same day.
• You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your healthcare provider because you might be pregnant.
• You could become pregnant if you have sex during the first 7 days after you restart your pills. You MUST use a non-hormonal birth control method (such as a condom and spermicide) as a back-up for those 7 days after you restart your pills.

If you miss THREE OR MORE pills (blue or white) in a row at any time, follow these steps:

• Throw out the rest of the pill pack and start a new pack that same day.
• You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your healthcare provider because you might be pregnant.
• You could become pregnant if you have sex on the days when you missed pills or during the first 7 days after restarting your pills. You MUST use a non-hormonal birth control method (such as a condom and spermicide) as a back-up the next time you have sex and for the first 7 days after you restart your pills.

If you forget either of the 2 brown “reminder” pills in Week 4, follow these steps:

• Throw away the pill you missed.
• Start a new pack on the same day you usually start a new pack.
• You do not need to use a back-up method of birth control.

If you are still not sure what to do about the pills you have missed:

• Use a back-up method of birth control anytime you have sex.
• Keep taking one pill each day until you can reach your healthcare provider.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Overdose may cause nausea or vaginal bleeding in females.

No serious problems have been reported from a birth control pill overdose, even when accidentally taken by children.

Dosing information

• Take one tablet by mouth at the same time every day for 28 days.
• Take tablets in the order directed on the blister pack.

What are the side effects of Lo Loestrin FE?

Serious side effects of Lo Loestrin Fe and other birth control pills include:

• An increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35 (an increased risk of serious blood clots also occurs during pregnancy). It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke.
  Some examples of serious blood clots are blood clots in the:
  • Legs (deep vein thrombosis)
  • Lungs (pulmonary embolus)
  • Eyes (loss of eyesight)
  • Heart (heart attack)
  • Brain (stroke)
• High blood pressure, which may occur in a few women who take birth control pills
• Gallbladder problems, which may occur in a few women who take birth control pills
• Rare cancerous or noncancerous liver tumors, which may occur in a few women who take birth control pills

All of these events are uncommon in healthy women.

Buy vitamins and supplements

Call your healthcare provider right away if you have:

• Persistent leg pain
• Sudden shortness of breath
• Sudden blindness, partial or complete
• Severe pain or pressure in your chest
• Sudden, severe headache unlike your usual headaches
• Weakness or numbness in an arm or leg, or trouble speaking
• Yellowing of the skin or eyeballs

Common side effects of Lo Loestrin Fe and other birth control pills include:

• Spotting or bleeding between menstrual periods
• Nausea
• Breast tenderness
• Headache

These side effects are usually mild and usually disappear with time.

Less common side effects of Lo Loestrin Fe are:

• Acne
• Less sexual desire
• Bloating or fluid retention
• Blotchy darkening of the skin, especially on the face
• High blood sugar, especially in women who already have diabetes
• High fat (cholesterol, triglyceride) levels in the blood
• Depression, especially if you have had depression in the past. Call your healthcare provider immediately if you have any thoughts of harming yourself
• Problems tolerating contact lenses
• Weight gain

This is not a complete list of possible side effects. Talk to your healthcare provider if you develop any side effects that concern you. You may report side effects to the FDA at 1-800-FDA-1088.

Do birth control pills cause cancer?

It is not known if hormonal birth control pills cause breast cancer. Some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users with longer duration of use.

If you have breast cancer now, or have had it in the past, do not use hormonal birth control because some breast cancers are sensitive to hormones.

Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.

Interactions

Tell your healthcare provider about all medicines and herbal products that you take. Some medicines and herbal products may make birth control pills such as Lo Loestrin Fe less effective, including:

• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John’s wort
• topiramate

What is medroxyprogesterone?

Medroxyprogesterone tablets are used to treat abnormal menstrual bleeding, absent or irregular menstrual periods (amenorrhea) and to prevent thickening of the lining of the uterus (endometrial hyperplasia) in postmenopausal women who are taking estrogen hormone replacement therapy. Medroxyprogesterone is a progestin hormone.

Warnings

You should not use medroxyprogesterone if you are pregnant, or if you have liver disease, a hormone-related cancer such as breast or uterine cancer, a history of stroke or blood clot, or abnormal vaginal bleeding that has not been checked by a doctor.

Medroxyprogesterone should not be used to prevent heart disease, stroke, or dementia. This medicine may actually increase your risk of developing these conditions. Long-term use of medroxyprogesterone may increase your risk of breast cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risk.

Before taking this medicine

You should not use this medicine if you are allergic to medroxyprogesterone, or if you have:

• abnormal vaginal bleeding that has not been checked by a doctor;
• liver disease;
• a history of heart attack, stroke, or blood clot; or
• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.

Medroxyprogesterone may cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant.

Medroxyprogesterone should not be used to prevent heart disease, stroke, or dementia. This medicine may actually increase your risk of developing these conditions.

To make sure medroxyprogesterone is safe for you, tell your doctor if you have:

• heart problems;
• liver problems;
• asthma;
• migraine headaches;
• a thyroid disorder;
• endometriosis (severe pelvic pain);
• jaundice caused by pregnancy or birth control pills;
• kidney disease;
• high or low blood levels of calcium;
• a seizure;
• diabetes; or
• lupus.

Using this medicine can increase your risk of blood clots, stroke, or heart attack, especially if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.

Long-term use of medroxyprogesterone may increase your risk of cancer of the breast, uterus, or ovaries. Talk with your doctor about this risk.

Do not breastfeed.

How should I take medroxyprogesterone?

Take medroxyprogesterone exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Medroxyprogesterone is usually given for only a few days in a row each month.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using this medicine.

If you need major surgery or will be on long-term bed rest, you may need to stop using medroxyprogesterone for a short time. This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using medroxyprogesterone.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Endometrial Hyperplasia — Prophylaxis:

Oral tablets:
5 or 10 mg daily for 12 to 14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day of the cycle or the 16 th day of the cycle

Comments:
-Postmenopausal woman with a uterus taking estrogens should also initiate progestin therapy to reduce the risk of endometrial cancer.
-Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration. Starting dose should be the lowest.
-Periodically re-evaluation (e.g., 3 to 6 month intervals) to determine if treatment is still necessary is recommended.
-In women with uterus, endometrial sampling should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

Use: Prevention of endometrial hyperplasia in non-hysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets

Usual Adult Dose for Abnormal Uterine Bleeding:

Oral tablets:
-5 or 10 mg daily for 5 to 10 days, beginning on the 16 th or 21 st day of the menstrual cycle

-Dose to produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen: 10 mg daily for 10 days beginning on the 16 th day of the cycle

Comments:
-Withdrawal bleeding usually occurs within 3 to 7 days after discontinuing therapy with the oral tablets.
-Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with the oral tablets.

Use: Abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer

Usual Adult Dose for Amenorrhea:

Oral tablets:
-5 or 10 mg daily for 5 to 10 days

Dose for inducing an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen:
-10 mg daily for 10 day

Comments:
-Therapy may be started at any time.
-Withdrawal bleeding usually occurs within 3 to 7 days after discontinuing therapy with this drug.

Use: Treatment of secondary amenorrhea due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking medroxyprogesterone?

Avoid smoking while you are taking medroxyprogesterone. Smoking greatly increases your risk of blood clots.

Medroxyprogesterone side effects

Get emergency medical help if you have signs of an allergic reaction to medroxyprogesterone: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• signs of a stroke – sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot – sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
• heart attack symptoms – chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems – loss of appetite, upper stomach pain, tiredness, fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• unusual vaginal bleeding;
• confusion, memory problems;
• a breast lump; or
• symptoms of depression – sleep problems, weakness, tired feeling, mood changes.

Common medroxyprogesterone side effects may include:

• spotting or breakthrough bleeding;
• changes in your menstrual periods;
• vaginal itching or discharge;
• headache, dizziness, feeling nervous or depressed;
• breast tenderness or discharge;
• stomach discomfort, bloating, nausea, vomiting;
• itching, rash, acne, hair growth, hair loss;
• premenstrual type symptoms (bloating, fluid retention, mood changes);
• weight gain;
• bruising or swelling of your veins;
• tiredness, trouble sleeping; or
• vision changes and difficulty wearing contact lenses.

What is norethindrone?

Norethindrone is a form of progesterone, a female hormone important for regulating ovulation and menstruation.

Norethindrone is used for birth control (contraception) to prevent pregnancy.

Norethindrone is also used to treat menstrual disorders, endometriosis, or abnormal vaginal bleeding caused by a hormone imbalance.

Not all brands of norethindrone are for the same uses. Some brands are for use only as contraception. Others are for use in treating endometriosis or vaginal bleeding disorders. Avoid medication errors by using only the brand, form, and strength your doctor prescribes.

Norethindrone may also be used for other purposes not listed in this medication guide.

Norethindrone side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Norethindrone may cause serious side effects. Call your doctor at once if you have:

• sudden vision loss, bulging eyes, or severe headache;
• swelling, rapid weight gain;
• unusual vaginal bleeding;
• missed menstrual periods;
• pelvic pain (especially on one side);
• a breast lump;
• a light-headed feeling, like you might pass out;
• increased thirst, increased urination;
• liver problems–loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes); or
• signs of a blood clot–sudden numbness or weakness, problems with vision or speech, chest pain, shortness of breath, swelling or redness in an arm or leg.

Common side effects of norethindrone may include:

• irregular vaginal bleeding or spotting;
• headache;
• breast pain or swelling;
• stomach pain, bloating, nausea, vomiting;
• hair loss;
• depressed mood, trouble sleeping;
• weight gain; or
• vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

You should not use norethindrone if you you have: undiagnosed vaginal bleeding, breast cancer, liver disease, or a liver tumor. You may not be able to take norethindrone if you have ever had a heart attack, a stroke, or blood clot.

Do not use if you are pregnant or trying to become pregnant.

In some cases, you should not take norethindrone if you are nursing.

Before taking this medicine

You should not use norethindrone if you are allergic to it, or if you have:

• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease or a liver tumor;
• breast cancer; or
• a history of blood clots in your brain, eyes, lungs, or legs.

Do not use norethindrone if you are pregnant or trying to become pregnant. Stop taking the medicine and tell your doctor right away if you become pregnant.

Ask your doctor about using this medicine while you are breast-feeding. In some cases, you should not take norethindrone if you are nursing.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;
• liver disease;
• depression;
• migraine headaches;
• diabetes;
• high cholesterol or triglycerides;
• uterine fibroid tumors;
• epilepsy;
• kidney disease;
• asthma; or
• if you smoke.

Do not give this medicine to a child without medical advice.

How should I take norethindrone?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Carefully follow your doctor’s dosing instructions about when to start taking norethindrone for contraception if you are switching from a combination birth control pill (estrogen and progestin).

If you take norethindrone for contraception: Take one pill every day, no more than 24 hours apart. You may get pregnant if you do not take one pill daily.

You may need to use back-up birth control (such as condoms with spermicide) if you are sick with vomiting or diarrhea, or if you are 3 or more hours late in taking your daily dose.

If you take norethindrone for menstrual disorders or abnormal vaginal bleeding: You will most likely take the medicine for only 5 to 10 days. Vaginal bleeding will occur 3 to 7 days after your last dose.

If you take norethindrone for endometriosis: Norethindrone is usually taken daily long-term for several months. Your doctor may occasionally change your dose.

Your doctor should check your progress on a regular basis. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms.

Report any unusual vaginal bleeding right away.

Norethindrone can affect the results of certain medical tests. Tell any doctor who treats you that you are using norethindrone.

Store this medication at room temperature away from moisture, heat, and light.

Norethindrone dosing information

Usual Adult Dose for Abnormal Uterine Bleeding:

2.5 to 10 mg orally once a day
Duration of therapy: 5 to 10 days

Comments:
-This drug should be used when the endometrium is adequately primed with endogenous/exogenous estrogen.
-Withdrawal bleeding typically occurs within 3 to 7 days of treatment discontinuation.

Use: Treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance without organic pathology (e.g., submucous fibroids, uterine cancer)

Usual Adult Dose for Amenorrhea:

2.5 to 10 mg orally once a day
Duration of therapy: 5 to 10 days

Comments:
-This drug should be used when the endometrium is adequately primed with endogenous/exogenous estrogen.
-Withdrawal bleeding typically occurs within 3 to 7 days of treatment discontinuation.

Use: Treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance without organic pathology (e.g., submucous fibroids, uterine cancer)

Usual Adult Dose for Contraception:

0.35 mg orally once a day

Comment:
-This drug should be taken at the same time each day.

Use: Prevention of pregnancy

Usual Adult Dose for Endometriosis:

Initial dose: 5 mg orally once a day for 2 weeks
-Maximum dose: 15 mg/day

Comments:
-The dose should be increased by 2.5 mg/day every 2 weeks until 15 mg is reached.
-Treatment may continue for 6 to 9 months OR until annoying breakthrough bleeding demands temporary termination.

Uses: Treatment of endometriosis

Usual Pediatric Dose for Contraception:

Postpubertal adolescents (under 16 years): 0.35 mg orally once a day

Comments:
-This drug should be used after menarche occurs.
-The dose should be taken at the same time each day.

Use: Prevention of pregnancy

What happens if I miss a dose?

Call your doctor for instructions, or follow the patient instructions provided with your medicine.

Missing a birth control pill increases your risk of becoming pregnant. If you are more than 3 hours late for your dose, take the medicine as soon as you remember and use back-up birth control for at least 48 hours. Take your next pill at the regularly scheduled time and continue on your regular dosing schedule.

If you miss a period for two months in a row, call your doctor because you might be pregnant.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

An overdose of norethindrone is not expected to be dangerous.

What should I avoid while taking norethindrone?

Do not use estrogen medication unless your doctor tells you to.

Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while taking norethindrone for contraception.

Norethindrone will not protect you from sexually transmitted diseases–including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

What other drugs will affect norethindrone?

Some drugs can make norethindrone less effective, which may result in unintended pregnancy if you use norethindrone for contraception. Tell your doctor about all your other medicines, especially:

• St. John’s wort;
• medicine to treat an infection (antibiotics or antifungal medicine);
• medicine to treat tuberculosis;
• medicine to treat HIV or AIDS; or
• seizure medication.

Oral route(Tablet)

Cigarette smoking increases the risk of serious cardiovascular events from oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. Women who are over 35 years of age and smoke should not use oral contraceptives .

Uses for Ocella

Drospirenone and ethinyl estradiol combination is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, ethinyl estradiol and drospirenone, and when taken properly, prevents pregnancy. It works by stopping a woman’s egg from fully developing each month. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented.

This medicine is also used to treat premenstrual dysphoric disorder (PMDD) and acne in women at least 14 years of age. PMDD is a severe form of premenstrual syndrome (PMS). Patients with PMDD may have severe emotional and physical symptoms 10 to 14 days before their menstrual flow starts.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.

This medicine does not prevent AIDS or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

This medicine is available only with your doctor’s prescription.

Before using Ocella

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of drospirenone and ethinyl estradiol combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.

Geriatric

Appropriate studies on the relationship of age to the effects of drospirenone and ethinyl estradiol combination have not been performed in the geriatric population. This medicine is not indicated for use in elderly women.

Breast Feeding

Drospirenone

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.Ethinyl Estradiol

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Atazanavir
• Boceprevir
• Cobicistat
• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amifampridine
• Amobarbital
• Amoxicillin
• Ampicillin
• Amprenavir
• Anagrelide
• Apalutamide
• Aprepitant
• Armodafinil
• Artemether
• Bacampicillin
• Belzutifan
• Betamethasone
• Bexarotene
• Boceprevir
• Bosentan
• Bupropion
• Butabarbital
• Butalbital
• Carbamazepine
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixime
• Cefpodoxime
• Cefprozil
• Ceftazidime
• Ceftibuten
• Cefuroxime
• Cenobamate
• Ceritinib
• Clobazam
• Cloxacillin
• Cobicistat
• Colesevelam
• Cyclacillin
• Cyclosporine
• Dabrafenib
• Darunavir
• Dexamethasone
• Dicloxacillin
• Dipyrone
• Donepezil
• Doxycycline
• Efavirenz
• Elagolix
• Elvitegravir
• Encorafenib
• Enzalutamide
• Eslicarbazepine Acetate
• Etravirine
• Felbamate
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Fostemsavir
• Glecaprevir
• Grazoprevir
• Griseofulvin
• Guar Gum
• Indinavir
• Iron
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lixisenatide
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mephobarbital
• Meropenem
• Methohexital
• Minocycline
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafcillin
• Nelfinavir
• Nevirapine
• Nirmatrelvir
• Octreotide
• Oxacillin
• Oxcarbazepine
• Oxytetracycline
• Paclitaxel
• Paclitaxel Protein-Bound
• Paritaprevir
• Penicillin G
• Penicillin G Procaine
• Penicillin V
• Pentobarbital
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pibrentasvir
• Piperaquine
• Pitolisant
• Prednisolone
• Prednisone
• Primidone
• Red Clover
• Rifabutin
• Rifampin
• Rifapentine
• Rilpivirine
• Ritonavir
• Rufinamide
• Saquinavir
• Secobarbital
• Simeprevir
• Somatrogon-ghla
• St John’s Wort
• Sugammadex
• Sultamicillin
• Tazemetostat
• Telaprevir
• Telotristat Ethyl
• Tetracycline
• Theophylline
• Thiopental
• Thioridazine
• Ticarcillin
• Tigecycline
• Tipranavir
• Tirzepatide
• Tizanidine
• Topiramate
• Troglitazone
• Ulipristal
• Valproic Acid
• Voxilaprevir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amitriptyline
• Atazanavir
• Atorvastatin
• Clomipramine
• Diazepam
• Doxepin
• Etoricoxib
• Ginseng
• Imipramine
• Lamotrigine
• Levothyroxine
• Licorice
• Liothyronine
• Lorazepam
• Parecoxib
• Roflumilast
• Selegiline
• Temazepam
• Tipranavir
• Triazolam
• Troleandomycin
• Valdecoxib
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (eg, deep vein thrombosis, pulmonary embolism), or history of or
• Adrenal gland problem or
• Blood disorders (eg, hypercoagulopathy) or
• Breast cancer, active or history of or
• Diabetes with kidney, eye, nerve, or blood vessel damage or
• Heart attack, history of or
• Heart or blood vessel disease (eg, coronary artery disease, heart valve problems), or history of or
• Heart rhythm problems (atrial fibrillation) or
• Hypertension (high blood pressure), uncontrolled or
• Kidney disease or
• Liver disease, including tumors or cancer or
• Migraine headache, new or worse or a new kind of headache or
• Problems with circulation or blood clots, now or in the past or
• Stroke, history of—Should not be used in patients with these conditions.

• Angioedema (swelling of the face, tongue, or throat), inherited or
• Cervical cancer or intraepithelial neoplasia or
• Chloasma gravidarum (skin disorder during pregnancy), history of or
• Cholestasis (bile problem) during pregnancy, history of or
• Depression, history of or
• Diabetes or
• Dyslipidemia (high cholesterol or fats in the blood), uncontrolled or
• Gallbladder disease or
• Hyperkalemia (high potassium in the blood) or
• Hypertension (high blood pressure), controlled—Use with caution. May make these conditions worse.

Proper use of Ocella

It is very important that you use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

To make using oral contraceptives as safe and reliable as possible, you should understand how and when to take them and what effects may be expected.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine is available in blister packs. Each blister pack contains 28 tablets with different colors that need to be taken in the same order as directed on the blister pack.

When you begin using this medicine, your body will require at least 7 days to adjust before a pregnancy will be prevented. Use a second form of contraception (eg, condom, spermicide, or diaphragm) for the first 7 days of your first cycle of pills.

Take this medicine at the same time each day, after the evening meal or at bedtime. You may take this medicine with or without food.

Do not skip or delay taking your pill by more than 24 hours. If you miss a dose, you could get pregnant. Ask your doctor for ways to help you remember to take your pills or about using another method of birth control.

You may have light bleeding or spotting when you first take the pill.

You may feel sick or nauseous, especially during the first few months that you take this medicine. If your nausea is continuous and does not go away, call your doctor.

If you vomit or have diarrhea within 3 to 4 hours of taking this medicine, treat this as a missed dose and follow the instructions in the patient leaflet or call your doctor.

If you are switching from a combination hormonal method (eg, another pill, patch, vaginal ring) to using Yasmin® or Yaz®, take the medicine on the day you would have usually taken your next pill If you do not start your period, see your doctor for a pregnancy test. If you have used a vaginal ring or patch, take the pill on the day the ring or patch is removed. You must also use a second method of birth control (eg, condom, diaphragm, spermicide) for the first 7 days you take this medicine.

If you are switching from a progestin-only method (eg, progestin-only pill, implant, injection, intrauterine system) to using Yasmin® or Yaz®, take the medicine on the day you would have taken your next progestin-only pill, or on the day your implant or IUD is removed, or on the day you would have your next injection. You must also use a second method of birth control (eg, condom, diaphragm, spermicide) for the first 7 days you take this medicine.

If you have a miscarriage or abortion after the second trimester or if you gave birth and chose not to breastfeed, you may start using this medicine after 4 weeks to prevent the risk of having blood clots.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 start) or on the first Sunday after your menstrual period starts (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even if you miss a dose. Do not change your schedule on your own. If the schedule that you use is not convenient, check with your doctor about changing it. For a Sunday start, you need to use another form of birth control (eg, condom, diaphragm, spermicide) for the first 7 days.

You should begin your next and all subsequent 28-day regimens of therapy on the same day of the week as the first regimen began and follow the same schedule.

• For oral dosage form (tablets):
  • For contraception (to prevent pregnancy), PMDD, or acne:
    • Adults and teenagers—
      • Yasmin®: One yellow tablet (active) taken at the same time each day for 21 consecutive days followed by one white (inert) tablet daily for 7 days per menstrual cycle.
      • Yaz®: One pink tablet (active) taken at the same time each day for 24 consecutive days followed by one white (inert) tablet daily for 4 days per menstrual cycle.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

This medicine has specific patient instructions on what to do if you miss a dose. Read and follow these instructions carefully and call your doctor if you have any questions.

• Yasmin®:
  • If you miss one yellow pill: Take the pill as soon as possible and take the next pill at your regular schedule.
  • f you miss two yellow pills in week 1 or 2: Take the two pills as soon as possible and the next two pills the next day. Continue taking one pill a day until you finish the pack. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose.
  • If you miss two yellow pills in week 3 or 4, or if you miss three or more yellow pills in a row in any week:
    • Day 1 start: Throw out the rest of the pack and start a new pack that same day.
    • Sunday start: Continue taking one pill a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy. If you miss your menstrual period 2 months in a row, check with your doctor because you might be pregnant.
  • If you miss any of the seven white pills in week 4: Throw away the pills you missed. Continue taking one pill a day until you finish the pack.
• Yaz®:
  • If you miss one light pink tablet: Take the tablet as soon as possible and take the next tablet at your regular schedule. This means that you may take 2 pills in 1 day. Continue taking one tablet a day until you finish the pack. You do not need to use another form of birth control if you have sex.
  • If you miss two light pink tablets in Week 1 or 2: Take the two tablets as soon as possible and the next two tablets the next day. Continue taking one tablet a day until you finish the pack. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose.
  • If you miss two light pink tablets in Week 3 or 4:
    • Day 1 start: Throw out the rest of the pack and start a new pack that same day.
    • Sunday start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy.
    • If you miss two periods in a row, call your doctor for a pregnancy test before you take any more pills.
  • If you miss three or more light pink tablets:
    • Day 1 start: Throw out the rest of the pack and start a new pack that same day.
    • Sunday start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy.
    • If you miss two periods in a row, call your doctor for a pregnancy test before you take any more pills.
  • If you miss four white tablets in Week 4: Throw out the pill you missed. Keep taking one tablet each day until the pack is empty. You do not need to use another form of birth control if you have sex.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions while using Ocella

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often. Your doctor may also want to check your blood pressure while taking this medicine.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Make sure your doctor knows if you have had a baby within 4 weeks before you start using this medicine.

Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier.

• If this should occur, continue with your regular dosing schedule.
• The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week.
• If the bleeding continues after you have been taking hormonal contraceptives on schedule and for more than 3 months, check with your doctor.

Check with your doctor right away if you miss a menstrual period. Missed periods may occur if you skip one or more tablets and have not taken your pills exactly as directed. If you miss two periods in a row, talk to your doctor. You might need a pregnancy test.

If you suspect that you may be pregnant, and check with your doctor immediately.

Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using birth control pills containing drospirenone, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Using this medicine may increase your risk of having blood clotting problems, especially in the first 6 months of use. This risk may be higher if you are using a birth control pill containing drospirenone and ethinyl estradiol. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, unexplained trouble breathing, a sudden loss of coordination, or vision changes while using this medicine.

Check with your doctor immediately if you wear contact lenses or if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want an eye doctor to check your eyes.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.

Make sure any doctor or dentist who treats you knows that you are using this medicine. The results of some medical tests may be affected by this medicine. You may also need to stop using this medicine at least 4 weeks before and 2 weeks after having major surgery.

This medicine may cause skin discoloration. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John’s wort) or vitamin supplements.

Side Effects of Ocella

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Breast pain or tenderness
• headache, severe and throbbing
• heavy non-menstrual vaginal bleeding
• irregular menstrual periods
• nausea
• normal menstrual bleeding occurring earlier, possibly lasting longer than expected

Less common

• Longer or heavier menstrual periods
• unusual tiredness or weakness
• vomiting

Incidence not known

• Chills
• clay-colored stools
• dark urine
• difficulty with breathing
• dizziness
• fever
• headache
• itching
• loss of appetite
• pain in the chest, groin, or legs, especially the calves
• rash
• slurred speech
• stomach pain
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg
• unpleasant breath odor
• unusual tiredness or weakness
• vision changes
• vomiting of blood
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Crying
• decreased interest in sexual intercourse
• delusions of persecution, mistrust, suspiciousness, or combativeness
• false or unusual sense of well-being
• inability to have or keep an erection
• irritability
• loss in sexual ability, desire, drive, or performance
• mental depression
• quick to react or overreact emotionally
• rapidly changing moods
• weight gain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Commonly used brand name(s)

In the U.S.

• Gianvi
• Loryna
• Nikki
• Ocella
• Syeda
• Vestura
• Yasmin
• YAZ
• Yaz 28
• Zarah

What is Ortho Tri-Cyclen?

Ortho Tri-Cyclen is a combination birth control pill containing the female hormones ethinyl estradiol and norgestimate. These hormones prevent ovulation (the release of an egg from an ovary).

Ortho Tri-Cyclen also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ortho Tri-Cyclen is used as contraception to prevent pregnancy.

Ortho Tri-Cyclen is also used to treat moderate acne vulgaris in females who are at least 15 years old. This medicine should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.

Warnings

Do not use Ortho Tri-Cyclen if you are pregnant or if you have recently had a baby.

You should not use Ortho Tri-Cyclen if you have: uncontrolled high blood pressure, heart disease, coronary artery disease, circulation problems (especially with diabetes), undiagnosed vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you also take certain hepatitis C medication, if you will have major surgery, if you smoke and are over 35, or if you have ever had a heart attack, a stroke, a blood clot, jaundice caused by pregnancy or birth control pills, or cancer of the breast, uterus/cervix, or vagina.

Taking birth control pills can increase your risk of blood clots, stroke, or heart attack.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not take Ortho Tri-Cyclen if you smoke and are over 35 years old.

Before taking this medicine

Taking Ortho Tri-Cyclen can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of taking birth control pills. Your risk is also high when you restart birth control pills after not taking them for 4 weeks or longer.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not take combination birth control pills if you smoke and are over 35 years old.

Do not use Ortho Tri-Cyclen if you are pregnant. Stop using this medicine and tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills.

You should not take Ortho Tri-Cyclen if you have:

• untreated or uncontrolled high blood pressure;
• heart disease (chest pain, coronary artery disease, history of heart attack, stroke, or blood clot);
• an increased risk of having blood clots due to a heart problem or a hereditary blood disorder;
• circulation problems (especially if caused by diabetes);
• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina;
• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease or liver cancer;
• severe migraine headaches (aura, numbness, vision changes), especially if you are older than 35; or
• if you take any hepatitis C medication containing ombitasvir/paritaprevir/ritonavir (Technivie).

To make sure Ortho Tri-Cyclen is safe for you, tell your doctor if you have ever had:

• heart problems, high blood pressure, or if you are prone to having blood clots;
• high cholesterol or triglycerides, or if you are overweight;
• depression;
• a seizure or migraine headache;
• diabetes, gallbladder disease, underactive thyroid;
• liver or kidney disease;
• jaundice caused by pregnancy or birth control pills;
• irregular menstrual cycles; or
• fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

This medicine can slow breast milk production. Tell your doctor if you are breast-feeding.

How should I take Ortho Tri-Cyclen?

Take Ortho Tri-Cyclen exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You will take your first pill on the first day of your period or on the first Sunday after your period begins. You may need to use back-up birth control, such as condoms with spermicide, when you first start using Ortho Tri-Cyclen. Follow your doctor’s instructions.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not take one pill daily.

Ortho Tri-Cyclen packs contain seven dark green “reminder” pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Use a back-up birth control if you are sick with severe vomiting or diarrhea.

If you need major surgery with long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using Ortho Tri-Cyclen.

While taking Ortho Tri-Cyclen, you will need to visit your doctor regularly.

Store this medicine at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose of Ortho Tri-Cyclen for Contraception:

1 tablet orally once a day

Usual Adult Dose for Acne:

1 tablet orally once a day

Comments: Not all preparations are indicated for the treatment of acne; the manufacturer product information should be consulted.

Usual Pediatric Dose for Acne:

15 years or older: 1 tablet orally once a day

-Use should be reserved for the treatment of acne only if the patient desires an oral contraceptive for birth control.

Use: For the treatment of moderate acne vulgaris in females at least 15 years of age with no know contraindications to oral contraceptive therapy and who have achieved menarche.

What happens if I miss a dose?

Follow the instructions provided with your medicine. Missing an Ortho Tri-Cyclen pill increases your risk of becoming pregnant.

If you miss 1 active pill, take 2 pills on the day you remember. Then take 1 pill per day for the rest of the pack.

If you miss 2 active pills in a row in Week 1 or 2, take 2 pills per day for 2 days in a row. Then take 1 pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss 2 active pills in a row in Week 3, throw out the pack and start a new pack the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day.

If you miss 3 active pills in a row in Week 1, 2, or 3, throw out the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day.

If you miss 2 or more pills, you may not have a period during the month. If you miss a period for 2 months in a row, call your doctor because you might be pregnant.

If you miss a reminder pill, throw it away and keep taking one reminder pill per day until the pack is empty.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Do not smoke while taking Ortho Tri-Cyclen, especially if you are older than 35 years of age.

Ortho Tri-Cyclen will not protect you from sexually transmitted diseases, including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Ortho Tri-Cyclen side effects

Get emergency medical help if you have signs of an allergic reaction to Ortho Tri-Cyclen: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Ortho Tri-Cyclen and call your doctor at once if you have:

• signs of a stroke – sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot – sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
• heart attack symptoms – chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems – loss of appetite, upper stomach pain, tiredness, fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• severe headache, pounding in your neck or ears;
• swelling in your hands, ankles, or feet;
• changes in the pattern or severity of migraine headaches;
• a breast lump; or
• symptoms of depression – sleep problems, weakness, tired feeling, mood changes.

Common Ortho Tri-Cyclen side effects may include:

• stomach pain, gas, nausea, vomiting;
• breast tenderness;
• acne, darkening of facial skin;
• headache, nervousness, mood changes;
• problems with contact lenses;
• changes in weight;
• breakthrough bleeding;
• vaginal itching or discharge; or
• rash.

What is Plan B?

Plan B is an over-the-counter emergency contraceptive pill used to help prevent pregnancy after unprotected sex or contraceptive failure, including a broken condom, missed birth control pills. Plan B (levonorgestrel) works by temporarily delaying ovulation (the release of an egg), which helps prevent pregnancy before it can happen.

Plan B is most effective when taken as soon as possible, within 72 hours (3 days) of unprotected sex. While it’s often called the “morning-after pill,” it can be taken any time within that 72-hour window.

Anyone, regardless of age or gender can purchase Plan B One-Step right off the shelf without a prescription or ID requirement at all major retailers in the U.S.

The Plan B pill is a backup method of preventing pregnancy and should not be used as a regular form of birth control. Talk with your doctor or healthcare professional about the many forms of birth control available.

How effective is Plan B?

According to a clinical trial, Plan B reduced the average chance of pregnancy from about 8% to 1.1% after a single act of unprotected sex during the most fertile part of the menstrual cycle, provided it was taken within 72 hours.

In a review of clinical trials, Plan B was shown to have an efficiency rate of 89% when taken correctly, as directed.

How does Plan B work? 

Plan B contains a hormone called levonorgestrel (1.5mg). It works by blocking the surge of luteinizing hormone, which typically happens before ovulation occurs (when your ovary releases an egg). This delays or stops ovulation. Additionally, Plan B thickens cervical mucus, which affects how well sperm can move and reach the released eggs. These actions help prevent fertilization of an egg so that pregnancy cannot occur.

Plan B side effects

Common Plan B side effects

Common Plan B side effects can include: 

• stomach pain;
• breast pain or tenderness;
• nausea, vomiting, diarrhea;
• headache, dizziness;
• feeling tired; or
• changes in your menstrual periods, including your period being earlier or later than expected.

Serious Plan B side effects

Allergic reaction: Get emergency medical help if you have signs of an allergic reaction to this medicines. Symptoms may include hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tubal (ectopic) pregnancy: Call your doctor or seek emergency medical help if you have severe pain in your lower stomach or side. This could be a sign of a tubal pregnancy (a pregnancy that implants in the fallopian tube instead of the uterus). A tubal pregnancy is a medical emergency that needs medical treatment immediately.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Do not use this medicine if you are already pregnant. Levonorgestrel will not terminate a pregnancy that has already begun (the fertilized egg has attached to the uterus).

Ask a doctor or pharmacist before taking levonorgestrel if you regularly use medication for seizures, tuberculosis, or HIV/AIDS. Certain medications can make levonorgestrel less effective as an emergency form of contraception.

Before taking this medicine

You should not use Plan B  if you are allergic to levonorgestrel or any of the ingredients in this medicine. A list of all ingredients is near the bottom of this page.

Pregnancy

Do not use this medicine if you are already pregnant. This medicine will not terminate a pregnancy that has already begun (the fertilized egg has attached to the uterus).

Breastfeeding

Levonorgestrel may slow breast milk production. Tell your doctor or healthcare professional if you are breastfeeding.

How should I take Plan B?

Take Plan B One-Step exactly as directed on the label, or as prescribed by your doctor or health professional.

Plan B One-Step (levonorgestrel 1.5 mg) is one tablet that is taken once.  It must be taken as soon as possible and no later than 72 hours (3 days) after unprotected sex.  The sooner the tablet is taken, the better it works.

Call your doctor right away if you vomit within 2 hours after taking this medicine, as you may need to take another tablet.

Visit your doctor within 3 weeks after taking this medicine. A doctor should confirm that you are not pregnant and that this medicine has not caused any harmful effects.

If your period is late by 1 week or longer after the expected date, you may be pregnant. Get a pregnancy test and contact your doctor if you are pregnant. Levonorgestrel will not terminate a pregnancy if the fertilized egg has attached to the uterus.

Plan B dosing information

• Plan B One-Step (levonorgestrel 1.5 mg) is one tablet that is taken within 72 hours (3 days) of unprotected sex. The sooner the tablet is taken, the more effective it is.
• Plan B contained two levonorgestrel 0.75 mg tablets and was taken as one tablet at once, followed by a second tablet 12 hours later. Plan B should be taken within 72 hours (3 days) of unprotected sex. This dose is now discontinued.

What happens if I miss a dose?

Since this medicine is used as a single dose, it does not have a daily dosing schedule.

What happens if I overdose?

Because this medicine is supplied as a single tablet in an exact strength, an overdose is unlikely to occur when this medicine is used as directed. Do not take more than one tablet at the same time.

What to avoid

This medicine will not protect you from sexually transmitted diseases–including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases. Avoid having unprotected sex.

What is Yasmin?

Yasmin is a combination birth control pill containing female hormones that prevent ovulation (the release of an egg from an ovary).

Yasmin also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Yasmin is used as contraception to prevent pregnancy.

Warnings

Do not use Yasmin if you are pregnant or if you recently had a baby.

You should not take Yasmin if you have: an adrenal gland disorder, kidney disease, uncontrolled high blood pressure, heart disease, coronary artery disease, circulation problems (especially with diabetes), undiagnosed vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you also take certain hepatitis C medication, if you will have major surgery, if you smoke and are over 35, or if you have ever had a heart attack, a stroke, a blood clot, jaundice caused by pregnancy or birth control pills, or cancer of the breast, uterus/cervix, or vagina.

Taking Yasmin can increase your risk of blood clots, stroke, or heart attack.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not take Yasmin if you smoke and are over 35 years old.

Yasmin side effects

Get emergency medical help if you have signs of an allergic reaction to Yasmin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Yasmin and call your doctor at once if you have:

• signs of a stroke – sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot – sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth and swelling in one or both legs;
• heart attack symptoms – chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems – loss of appetite, upper stomach pain, tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• increased blood pressure – severe headache, blurred vision, pounding in your neck or ears;
• swelling in your hands, ankles, or feet;
• a change in the pattern or severity of migraine headaches; or
• symptoms of depression – sleep problems, weakness, tired feeling, mood changes.

Common Yasmin side effects may include:

• nausea, vomiting;
• breast tenderness;
• headache, mood changes, feeling tired or irritable;
• weight gain; or
• changes in your menstrual periods, decreased sex drive.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking this medicine

Taking Yasmin can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of taking birth control pills. Your risk is also high when you restart birth control pills after not taking them for 4 weeks or longer.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not take Yasmin if you smoke and are over 35 years old.

Do not use if you are pregnant. Stop using Yasmin and tell your doctor right away if you become pregnant, or if you miss 2 menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking this medicine.

You should not take Yasmin if you have:

• an adrenal gland disorder;
• kidney disease;
• untreated or uncontrolled high blood pressure;
• heart disease (coronary artery disease, history of heart attack, stroke, or blood clot);
• an increased risk of having blood clots due to a heart problem or a hereditary blood disorder;
• circulation problems (especially if caused by diabetes);
• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina;
• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease or liver cancer;
• severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35;
• a history of jaundice caused by pregnancy or birth control pills;
• if you smoke and are over 35 years old; or
• if you take any hepatitis C medication containing ombitasvir/paritaprevir/ritonavir (Technivie).

To make sure Yasmin is safe for you, tell your doctor if you have ever had:

• heart problems, high blood pressure, or if you are prone to having blood clots;
• high levels of potassium in your blood;
• high cholesterol or triglycerides, or if you are overweight;
• depression;
• liver or kidney disease;
• underactive thyroid, diabetes, gallbladder disease; or
• a migraine headache.

The hormones in Yasmin can pass into breast milk and may harm a nursing baby. This medicine may also slow breast milk production. Do not use if you are breast feeding.

Yasmin pregnancy and breastfeeding warnings 

How should I take Yasmin?

Take Yasmin exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take Yasmin in larger or smaller amounts or for longer than recommended. Take your first pill on the first day of your period or on the first Sunday after your period begins. You may need to use back-up birth control, such as condoms with spermicide, when you first start using this medication.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You could get pregnant if you do not take one pill daily.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using Yasmin.

Store Yasmin at room temperature away from moisture and heat.

What happens if I miss a dose?

Follow the patient instructions provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions. Missing a pill increases your risk of becoming pregnant.

If you miss 1 active pill, take 2 pills on the day that you remember. Then take 1 pill per day for the rest of the pack.

If you miss 2 active pills in a row in Week 1 or 2, take 2 pills per day for 2 days in a row. Then take 1 pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss 2 active pills in a row in Week 3, throw out the rest of the pack and start a new pack the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day.

If you miss 3 active pills in a row in Week 1, 2, or 3, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day.

If you miss 2 or more pills, you may not have a period during the month. If you miss a period for 2 months in a row, call your doctor because you might be pregnant.

If you miss a reminder pill, throw it away and keep taking 1 reminder pill per day until the pack is empty.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose may cause nausea or vaginal bleeding.

What to avoid

Do not smoke while taking Yasmin, especially if you are older than 35 years of age.

Yasmin will not protect you from sexually transmitted diseases, including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

What other drugs will affect Yasmin?

Other drugs may interact with drospirenone and ethinyl estradiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Some drugs can make this medicine less effective, which may result in pregnancy. Tell your doctor about all your current medicines and any medicine you start or stop using.