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.

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.

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 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 Nexplanon?

Nexplanon (etonogestrel implant) is a long-term, reversible birth control for women. It is a contraceptive implant that is a flexible, thin plastic rod that is about the length of a matchstick (4cm by 2mm), which is placed under the skin on the inner side of the upper arm by your doctor or other healthcare provider.

Once you have it placed in your arm you don’t need to think about contraception for the next three years, you don’t need to worry about forgetting to take it, whether you have used it correctly and there is no need to interrupt sex to organise contraception.

Nexplanon can be removed at any time and your fertility will return to normal.

How does Nexplanon work?

The rod contains a hormone called etonogestrel that slowly and steadily releases to prevent pregnancy. It does this by stopping the release of an egg from your ovary, thinning the lining of your uterus and thickening mucus in your cervix.

The implant is made of a material that can be seen on X-rays and sometimes your health provider may use an X-ray to help locate it for removal.

How is the Nexplanon implant used?

Nexplanon is inserted through a needle (under local anesthesia) into the skin of your upper arm, just inside and above the elbow. After the implant is inserted, your arm will be covered with 2 bandages. Remove the top bandage after 24 hours, but leave the smaller bandage on for 3 to 5 days. Keep the area clean and dry.

The timing of when you receive the Nexplanon implant depends on whether you were using birth control before, and what type it was. For more information about how quickly it works as a contraceptive see dosing information below.

You should be able to feel the implant under your skin. Tell your doctor if you cannot feel the implant at any time while it is in place.

The Nexplanon implant can remain in place for up to 3 years. If the implant is placed correctly, you will not need to use back-up birth control. Follow your doctor’s instructions.

You may have irregular and unpredictable periods while using Nexplanon. Tell your doctor if your periods are very heavy or long-lasting, or if you miss a period (you may be pregnant).

If you need major surgery or will be on long-term bed rest, or if you need medical tests, may need to have your Nexplanon implant removed for a short time. Any doctor or surgeon who treats you should know that you have a Nexplanon implant.

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

Call your doctor at once if it feels like the Nexplanon implant may be bent or broken while it is in your arm.

How do they remove Nexplanon?

To remove the device, your health care provider will inject a local anesthetic in your arm beneath the implant. They will make a small incision in your skin and will push the implant toward the incision until the tip is visible and can be grasped with forceps.

Your health care provider will then pull out the implant, close the incision and apply a pressure bandage. Contraceptive implant removal typically takes less than five minutes.

If you choose, a new device can be implanted as soon as the original device is removed. Be prepared to use another type of contraception right away if you don’t have a new device inserted.

For information on ‘Problems with Insertion and Removal’ see the section below called ‘What are the possible risks of using Nexplanon?’

How well does Nexplanon work?

If your Nexplanon implant is inserted correctly, it is one of the most effective types of birth control. Your chance of getting pregnant is very low, less than 1 pregnancy per 100 women.

This medicine may be less effective in overweight women.

Can you get pregnant using Nexplanon?

Yes, you can become pregnant using Nexplanon, but it is very rare. If you do become pregnant it is important to see your healthcare provider to make sure it is not an ectopic pregnancy, which is when the pregnancy is outside of the womb. Women on Nexplanon have a slightly higher risk of ectopic pregnancy compared to women not using birth control.

It is important to have the implant removed if you become pregnant and plan on maintaining the pregnancy. This medicine is not likely to cause birth defects if you become pregnant while using it.

Dosing information

How long does Nexplanon last?

Nexplanon lasts for 3 years and at the end of the 3 years your implant must be removed. If you still require contraception a new implant may be inserted at the time of removal. You can have Nexplanon removed at any time and you will return to your normal fertility.

How long does it take for Nexplanon to work?

How long before Nexplanon starts to working as a contraceptive depends on if you have previously been using no contraception, or another form of contraception or whether you have recently had a baby, miscarriage or abortion.

No previous contraception

• If you get Nexplanon inserted in the first 5 days of your period then you are protected from pregnancy right away and back-up contraception is not needed.
• If you get Nexplanon inserted at any other time of your period you will need to use a barrier form contraception for the first week of using Nexplanon.

Previous combination hormonal contraception (eg combined hormonal pills, vaginal ring or transdermal patch)

• If you have Nexplanon inserted on the day after the last active pill, or on the day of removal of the vaginal ring or transdermal patch, then you are protected from pregnancy right away and you won’t need a back-up contraception.
• If you have Nexplanon inserted after the above time you will need to use a barrier method until 7 days after insertion, and if unprotected intercourse has already occurred, pregnancy should be excluded.

Previous progestin-only contraceptives

• Injectable progestin contraceptives. The Nexplanon should be inserted on the day that the next injection is due, then you are protected from pregnancy right away and you don’t need to use any extra contraception.
• Progestin mini pill. Nexplanon should be inserted within 24 hours after taking the last tablet, so you are protected from pregnancy right away and you don’t need to use any extra contraception.
• Progestin contraceptive implant or intrauterine device (IUD). If Nexplanon is inserted on the same day the previous contraceptive implant or IUD is removed you will be protected from pregnancy right away and you don’t need to use any extra contraception.
• If you have Nexplanon insert after the above times you will need to use a barrier method of contraception until 7 days after insertion, and if unprotected intercourse has already occurred, pregnancy should be excluded.

Previous miscarriage or abortion

• First Trimester: Nexplanon should be inserted within 5 days following a first trimester abortion or miscarriage, to be protected from pregnancy right away and for back-up contraception not to be needed.
• Second Trimester: If Nexplanon is inserted between 21 to 28 days following second trimester abortion or miscarriage, you will be protected from pregnancy right away and back-up contraception will not be needed.
• If Nexplanon is inserted after the above times you will need to use a barrier method of contraception until 7 days after insertion, and if unprotected intercourse has already occurred, pregnancy should be excluded.

After giving birth

• Not Breastfeeding: When Nexplanon is inserted between 21 to 28 days postpartum then back-up contraception is not necessary. If inserted after this time then you should use a barrier method of contraception until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.
• Breastfeeding: If you are breastfeeding you should not have Nexplanon inserted until 4 weeks after you have given birth. You should use a barrier method until 7 days after insertion. If unprotected intercourse has already occurred, pregnancy should be excluded.

How soon can you get pregnant after Nexplanon removal?

Your fertility will return to normal after removal of Nexplanon, with women in studies becoming pregnant 7 to 14 days after removal. If you do not want to become pregnant then it is important to consider having another Nexplanon inserted at the same time as removal or starting another form of birth control.

What happens if I miss a dose?

Nexplanon is an implant that lasts for 3 years. It is not intended for contraceptive use after 3 years and should be replaced with a new one if you want to continue having contraceptive cover.

You should keep a record of when you had Nexplanon inserted and just before the end of the third year make an appointment for removal of the implant. You may have your Nexplanon replaced with a new one at the same appointment if you want to continue with contraception.

Warnings

Do not use Nexplanon if you are:

• pregnant or
• if you have had a baby less than 4 weeks ago and you are breastfeeding or
• if you have had a baby less than 3 weeks ago and you are not breastfeeding

You should not use a Nexplanon implant if you have: undiagnosed vaginal bleeding, liver disease or liver cancer, if you will be having major surgery, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.

Using a Nexplanon implant 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 smoke while using a Nexplanon implant.

Important information

Nexplanon 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.

Using a Nexplanon implant 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 using this medicine.

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.

Do not use it if you are pregnant. If you become pregnant, the Nexplanon implant should be removed if you plan to continue the pregnancy.

You may need to have a negative pregnancy test before receiving the implant.

You should not use hormonal birth control if you have:

• a history of heart attack, stroke, or blood clot
• 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 or
• liver disease or liver cancer.

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

• diabetes
• high cholesterol or triglycerides
• high blood pressure
• headaches
• gallbladder disease
• kidney disease
• depression or
• an allergy to numbing medicines.

Nexplanon may not be as effective in women who are overweight.

The Nexplanon implant should not be used in women younger than 18 years old.

Etonogestrel can pass into breast milk. Tell your doctor if you are breast-feeding. See breastfeeding information below for more information on Nexplanon and breastfeeding .

What are the side effects of Nexplanon?

What are the most common side effects I can expect while using Nexplanon?

Changes in Menstrual Bleeding Patterns (menstrual periods)

• The most common side effect of Nexplanon is a change in your normal menstrual bleeding pattern. In studies, one out of ten women stopped using the implant because of an unfavorable change in their bleeding pattern.
• You may experience longer or shorter bleeding during your periods or have no bleeding at all. The time between periods may vary, and in between periods you may also have spotting.

Tell your healthcare provider right away if:

• You think you may be pregnant
• Your menstrual bleeding is heavy and prolonged

Besides changes in menstrual bleeding patterns, other frequent side effects that caused women to stop using the implant include:

• Mood swings
• Weight gain
• Headache
• Acne
• Depressed mood

Other common side effects include:

• Headache
• Vaginitis (inflammation of the vagina)
• Weight gain
• Acne
• Breast pain
• Viral infections such as sore throats or flu-like symptoms
• Stomach pain
• Painful periods
• Mood swings, nervousness, or depressed mood
• Back pain
• Nausea
• Dizziness
• Pain
• Pain at the site of insertion

Implants have been reported to be found in a blood vessel, including a blood vessel in the lung which can be associated with shortness of breath, cough and/or the coughing up of blood or blood-stained mucus.

This is not a complete list of possible side effects. For more information, ask your healthcare provider for advice about any side effects that concern you. You may report side effects to the FDA .

What are the possible risks of using Nexplanon?

Problems with Insertion and Removal

The implant may not be placed in your arm at all due to a failed insertion. If this happens, you may become pregnant. Immediately after insertion, and with help from your healthcare provider, you should be able to feel the implant under your skin. If you can’t feel the implant, tell your healthcare provider.

Location and removal of the implant may be difficult or impossible because the implant is not where it should be. Special procedures, including surgery in the hospital, may be needed to remove the implant. If the implant is not removed, then the effects of Nexplanon will continue for a longer period of time.

Implants have been found in the pulmonary artery (a blood vessel in the lung). If the implant cannot be found in the arm, your healthcare provider may use x-rays or other imaging methods on the chest. If the implant is located in the chest, surgery may be needed.

Other problems related to insertion and removal are:

• Pain, irritation, swelling, or bruising at the insertion site
• Numbness and tingling at the insertion site
• Scarring, including a thick scar called a keloid around the insertion site
• Infection
• Scar tissue may form around the implant making it difficult to remove
• The implant may come out by itself. You may become pregnant if the implant comes out by itself. Use a back-up birth control method and call your healthcare provider right away if the implant comes out.
• The need for surgery in the hospital to remove the implant
• Injury to nerves or blood vessels in your arm
• The implant breaks making removal difficult

Ectopic Pregnancy

If you become pregnant while using Nexplanon, you have a slightly higher chance that the pregnancy will be ectopic (occurring outside the womb) than do women who do not use birth control. Unusual vaginal bleeding or lower stomach (abdominal) pain may be a sign of ectopic pregnancy. Ectopic pregnancy is a medical emergency that often requires surgery. Ectopic pregnancies can cause serious internal bleeding, infertility, and even death. Call your healthcare provider right away if you think you are pregnant or have unexplained lower stomach (abdominal) pain.

Ovarian Cysts

Cysts may develop on the ovaries and usually go away without treatment but sometimes surgery is needed to remove them.

Breast Cancer

It is not known whether Nexplanon use changes a woman’s risk for breast cancer. If you have breast cancer now, or have had it in the past, do not use this medicine because some breast cancers are sensitive to hormones.

Serious Blood Clots

Nexplanon may increase your chance of serious blood clots, especially if you have other risk factors such as smoking. 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 embolism)
• Brain (stroke)
• Heart (heart attack)
• Eyes (total or partial blindness)

The risk of serious blood clots is increased in women who smoke. If you smoke and want to use Nexplanon you should quit smoking. Talk to your healthcare provider as they may be able offer you solutions to help you quit.

Tell your healthcare provider at least 4 weeks before if you are going to have surgery or will need to be on bed rest. You have an increased chance of getting blood clots during surgery or bed rest.

Other Risks

A few women who use birth control that contains hormones may get:

• High blood pressure
• Gallbladder problems
• Rare cancerous or noncancerous liver tumors

Broken or Bent Implant

Can Nexplanon break in my arm? Yes, the implant can break or bend due to external forces (e.g., manipulation of the implant or contact sports). A broken implant may move from the insertion site. If you feel that the implant may have broken or bent while in your arm, contact your healthcare provider.

When should I call my healthcare provider?

Call your healthcare provider right away if you have:

• Pain in your lower leg that does not go away
• Severe chest pain or heaviness in the chest
• Sudden shortness of breath, sharp chest pain, or coughing blood
• Symptoms of a severe allergic reaction, such as swollen face, tongue or throat; trouble breathing or swallowing
• Sudden severe headache unlike your usual headaches
• Weakness or numbness in your arm, leg, or trouble speaking
• Sudden partial or complete blindness
• Yellowing of your skin or whites of your eyes, especially with fever, tiredness, loss of appetite, dark colored urine, or light-colored bowel movements
• Severe pain, swelling, or tenderness in the lower stomach (abdomen)
• Lump in your breast
• Problems sleeping, lack of energy, tiredness, or you feel very sad
• Heavy menstrual bleeding

Interactions

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Certain medicines may make Nexplanon less effective, including:

• aprepitant
• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John’s wort
• topiramate
• HIV medicines
• Hepatitis C Virus medicines

Ask your healthcare provider if you are not sure if your medicine is one listed above.

If you are taking medicines or herbal products that might make Nexplanon less effective, you and your healthcare provider may decide to leave Nexplanon in place; in that case, an additional non-hormonal contraceptive should be used. Because the effect of another medicine on Nexplanon may last up to 28 days after stopping the medicine, it is necessary to use the additional non-hormonal contraceptive for that long.

When you are using Nexplanon, tell all of your healthcare providers that you have this medicine in place in your arm.

Pregnancy and breastfeeding

Pregnancy: You should not use Nexplanon if you are pregnant. You may need to have a negative pregnancy test before Nexplanon is inserted. If you become pregnant while using Nexplanon you should have it removed if you plan to continue with the pregnancy.

Breastfeeding: If you are breastfeeding your child, you may use Nexplanon if 4 weeks have passed since you had your baby. A small amount of the hormone contained in Nexplanon passes into your breast milk. The health of breast-fed children whose mothers were using the implant has been studied up to 3 years of age in a small number of children. No effects on the growth and development of the children were seen.

Hormonal contraceptives, including etonogestrel, can sometimes reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women.

If you are breastfeeding and want to use Nexplanon, you should talk with your healthcare provider who can provide more information on hormonal or non-hormonal contraceptives.

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.

What is Opill?

Opill is an OTC birth control pill used to prevent pregnancy that is available without a prescription. Opill (norgestrel) is progestin-only contraceptive pill and is sometimes called a minipill, it does not contain estrogen. Opill works mainly by thickening your cervical mucus, which makes it difficult for sperm to reach the egg, and it may suppress the release of an egg from your ovary.

How effective is Opill? When Opill is taken correctly approximately 98 out of 100 sexually active women who used Opill for one year did not become pregnant, in clinical trials.

Opill birth control pill starts working 2 days after you start taking it, but you must take it every day at the same time each day for it to continue to be effective. You must take Opill continuously every day without a break between blister packs.

Opill birth control pill will not protect against HIV/AIDS or other sexually transmitted diseases.

Opill was FDA-approved for OTC (over-the-counter) use on July 13, 2023, and will be available in stores and online in March 2024.

Is Opill an OTC medicine?

Yes, Opill is the first daily birth control pill available OTC without a prescription in the United States.

You should not take Opill:

• if you currently have or have ever had breast cancer
• if you are already pregnant or think you may be pregnant
• with another birth control pill, vaginal ring, patch, implant, injection, or an IUD (intra-uterine device)
• as an emergency contraceptive (morning-after pill). Opill will not prevent pregnancy when used after unprotected sex.

Should I talk to a doctor before taking Opill?

If you have any of the following medical conditions, it is best to talk to a doctor before taking Opill:

• currently have vaginal bleeding between your periods, and you have not already talked to a doctor about it
• have liver problems
• have or ever had any cancer
• are taking a prescription medicine for seizures, tuberculosis, HIV/AIDS, or pulmonary hypertension
• you are taking a supplement containing St John’s Wort (an herbal ingredient)
• you have taken ulipristal acetate (an emergency contraceptive or morning-after pill) in the past 5 days.

Pregnancy

Talk to your healthcare provider right away if you think that you are pregnant. If you become pregnant while using this medicine, you should stop taking it and talk to your doctor. Occasionally, taking oral contraceptives such as Opill may increase your risk of having an ectopic pregnancy. This means that the pregnancy is outside of the uterus. Symptoms of an ectopic pregnancy are unusual vaginal bleeding or lower stomach area (abdominal) pain. Seek medical help immediately.

Opill will not delay your ability to get pregnant when you stop taking this medicine.

Breastfeeding

Although small amounts of progestin may pass into breast milk, Opill is considered safe and effective in breastfeeding women. No adverse effects have been found on either breastfeeding performance or infant health.

Warnings

Allergies. Do not take Opill if you are allergic to norgestrel or any of the inactive ingredients. Do not take Opill if you are allergic to FD C Yellow No. 5 (tartrazine). Some people who are allergic to aspirin can also have a tartrazine allergy. Symptoms include hives, facial swelling, asthma (wheezing), shock, skin redness, rash, and blisters. If you have symptoms of an allergic reaction, stop this medicine and seek medical help immediately. For a full list of ingredients .

Opill can increase the risk of:

• Ectopic pregnancy, be aware of the possibility of ectopic pregnancy in women who become pregnant or complain of lower abdominal pain while on Opill. Seek medical help if you have symptoms of an ectopic pregnancy, such as sudden or severe persistent pain in your lower belly, mainly on one side.
• Delayed follicular atresia/ovarian cysts, in some cases, they are associated with mild abdominal pain, and rarely they may twist or rupture, requiring surgical intervention.
• Bleeding pattern alterations, and irregular menstrual patterns are common among women using Opill. Undiagnosed abnormal uterine bleeding should be evaluated before Opill is taken. If uterine bleeding, together with the clinical history, is suggestive of infection, malignancy, pregnancy, or other conditions, rule out these conditions. If periods stop altogether, consider the possibility of pregnancy.
• Hepatic neoplasia/liver disease, stop Opill if jaundice or acute disturbances of liver function develop. Seek medical help if you have symptoms such as yellowing of your skin or whites of your eyes, especially if you have a fever, tiredness, loss of appetite, or dark-colored urine.

Opill dosing information

Take 1 tablet at the same time every day

• This tablet works best to prevent pregnancy when taken exactly as directed.
• You can start on any day of your cycle.
• Opill takes 48 hours (2 days) to start working. Use condoms (or another barrier contraceptive method) every time you have sex during the first 2 days of use after you start your first pack of Opill.

Never skip your daily tablet

• To prevent pregnancy, you need to take your tablet every day, even when you bleed or have spotting.
• When you finish a pack, you should start the next one the following day without a break.

If you are more than 3 hours late taking your tablet or miss taking your tablet on 1 or more days

• Take 1 tablet immediately, as soon as you remember.
• Then go back to taking your daily tablet at your usual time.
• Use a condom (or another barrier method) every time you have sex for the next 48 hours (2 days) because the medicine may not be effective.

If you vomit for any reason or have severe diarrhea within 4 hours of taking your daily tablet

• Use a condom (or another barrier method) every time you have sex for the next 48 hours (2 days) because the medicine may not be effective.

When do I need to use extra contraceptive protection?

You need to use extra contraceptive protection (condoms or another form of barrier contraception) every time you have sex for the next 2 days (48 hours)

• After you start your first pack.
• If you take a tablet more than 3 hours late or miss a tablet on 1 or more days.
• If you vomit or have severe diarrhea within 4 hours of taking a tablet.

Take a pregnancy test or talk to your doctor if:

• Your period is late after missing taking your tablets in the last month
• If you have not had a period for 2 months and believe you may be pregnant.
• Stop using this medicine, and talk to your doctor if you become pregnant while on the medication.

It is important to continue to see your healthcare provider for your regular healthcare visits.

Opill side effects

The most common Opill side effect is changes in menstrual periods (bleeding).

Less common Opill side effects include:

• headache
• dizziness
• nausea
• increased appetite
• abdominal pain, cramps and bloating
• fatigue
• vaginal discharge
• painful periods
• nervousness
• backache
• breast discomfort
• acne

You should talk to your doctor if:

• You have repeated vaginal bleeding after having sex.
• Your periods start lasting more than 8 days, or they are unusually heavy.
• You start having migraines with aura (headaches that start with vision changes), or if your migraine headaches get worse.

What happens if I miss a dose?

If you are more than 3 hours later taking your tablet or miss taking your tablet on 1 or more days:

• Take 1 tablet immediately, as soon as you remember.
• Then go back to taking your daily tablet at your usual time.
• Use a condom (or another barrier method) every time you have sex for the next 48 hours (2 days), because the medicine may not be effective.

What happens if I overdose?

Symptoms of overdosage may include nausea, vomiting, breast tenderness, dizziness, somnolence (drowsiness/fatigue), and withdrawal bleeding in females. There is no specific antidote, and further treatment of overdose, if necessary, is directed to the symptoms.

What other drugs will affect Opill?

Tell your pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Opill may affect the way other medicines work, and vice versa.

It is very important to tell your healthcare provider if you take any of the following medicines that have drug interactions with Opill:

• phenytoin
• carbamazepine
• barbiturates
• rifampin
• efavirenz
• bosentan
• ulipristal acetate
• any herbal preparations containing St. John’s Wort (hypericum perforatum).

What is progesterone?

Progesterone is a naturally occurring hormone important for the regulation of ovulation and menstruation. Progesterone is produced in high amounts in females by the ovaries. It is also produced in smaller amounts by the adrenal glands both males and females.

Progesterone is used to cause menstrual periods in women who have not yet reached menopause but are not having periods due to a lack of progesterone in the body. It is also used to prevent overgrowth in the lining of the uterus in postmenopausal women who are receiving estrogen hormone replacement therapy.

Progesterone should not be used to prevent heart disease or dementia, because this medicine may actually increase your risk of developing these conditions.

Warnings

Do not use progesterone without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

You should not use progesterone if you have: abnormal vaginal bleeding, a history of breast cancer, liver disease, or if you have recently had a heart attack, stroke, or blood clot.

Progesterone should not be used to prevent heart disease or dementia, because this medicine may actually increase your risk of developing these conditions.

Using progesterone can increase your risk of blood clots, stroke, heart attack, or breast cancer.

Some forms of this medication may contain peanut oil. Do not use this medicine without telling your doctor if you have a peanut allergy.

Before taking this medicine

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

• abnormal vaginal bleeding that a doctor has not checked;
• a history of breast cancer;
• liver disease;
• a peanut allergy;
• if you are pregnant;
• if you have had a stroke, heart attack, or blood clot within the past year; or
• if you have recently had an incomplete miscarriage or “missed” abortion.

Using progesterone can increase your risk of blood clots, stroke, heart attack, or breast cancer.

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

• heart disease, circulation problems;
• migraines;
• asthma;
• kidney disease;
• seizures or epilepsy;
• a history of depression; or
• risk factors for coronary artery disease (such as high blood pressure, diabetes, lupus, high cholesterol, family history of coronary artery disease, smoking, being overweight).

Do not use progesterone if you are pregnant. It could harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Progesterone can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I use progesterone?

Use progesterone exactly as it was prescribed for you. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Take the capsule with a full glass of water. It is best to take the medicine at night because this medicine can make you dizzy or drowsy.

Apply progesterone cream to the skin as directed by your doctor.

Progesterone is sometimes used for only a short time, such as 10 to 12 days during each menstrual cycle. Follow your doctor’s dosing instructions very carefully.

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

If you need surgery or medical tests or if you will be on 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 this medicine.

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

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Call your doctor if you miss more than one dose of this medication.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using progesterone?

Progesterone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Progesterone side effects

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

Call your doctor at once if you have:

• unusual vaginal bleeding;
• pain or burning when you urinate;
• a breast lump;
• sudden vision problems, severe headache or pain behind your eyes;
• symptoms of depression (sleep problems, weakness, mood changes);
• severe dizziness or drowsiness, spinning sensation, confusion, shortness of breath;
• heart attack symptoms – chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems – nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• signs of a stroke – sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with speech or balance;
• signs of a blood clot in the lung – chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
• signs of a blood clot in your leg – pain, swelling, warmth, or redness in one or both legs.

Common progesterone side effects may include:

• drowsiness, dizziness;
• breast pain;
• mood changes;
• headache;
• constipation, diarrhea, heartburn;
• bloating, swelling in your hands or feet;
• joint pain;
• hot flashes; or
• vaginal discharge.