What is Glyxambi?

Glyxambi contains a combination of empagliflozin and linagliptin. Empagliflozin and linagliptin are oral diabetes medicines that help control blood sugar levels. Empagliflozin works by helping the kidneys get rid of glucose from your bloodstream. Linagliptin works by regulating the levels of insulin your body produces after eating.

Glyxambi is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Glyxambi is also used to lower the risk of death from heart attack, stroke, or heart failure in adults with type 2 diabetes who also have heart disease.

This medicine is not for treating type 1 diabetes.

Warnings

You should not use Glyxambi if you have severe kidney disease (or if you are on dialysis) or diabetic ketoacidosis, or if you have ever had a severe allergic reaction to empagliflozin or linagliptin.

Call your doctor at once if you have signs of a serious side effect, such as severe pain in your upper stomach spreading to your back, vomiting, fast heart rate, dizziness, feeling very thirsty or hot, decreased urination, heavy sweating, or hot and dry skin.

In rare cases, Glyxambi can cause serious infections in the penis or vagina. Get medical help right away if you have burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, or if you don’t feel well.

Before taking this medicine

You should not use Glyxambi if you are allergic to empagliflozin or linagliptin, or if you have:

• severe kidney disease (or if you are on dialysis);
• a history of severe allergic or skin reaction after taking empagliflozin or linagliptin; or
• diabetic ketoacidosis (call your doctor for treatment).

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

• liver or kidney disease;
• a bladder infection or urination problems;
• a pancreas disorder;
• heart failure;
• gallstones;
• a genital infection (penis or vagina);
• alcoholism, or if you currently drink large amounts of alcohol;
• if you are on a low salt diet;
• if you are 65 or older.
• if you have a planned surgery; or
• if you have high cholesterol or triglycerides.

Follow your doctor’s instructions about using Glyxambi if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy.

You should not use Glyxambi during the second or third trimester of pregnancy.

You should not breastfeed while using Glyxambi.

How should I take Glyxambi?

Take Glyxambi exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose..

Glyxambi is usually taken in the morning, with or without food.

Your blood sugar will need to be checked often, and you may also need to test the level of ketones in your urine. Empagliflozin can cause life-threatening ketoacidosis (too much acid in the blood). Even if your blood sugar is normal, contact your doctor if a urine test shows that you have high ketones in the urine.

Blood sugar can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals.

Low blood sugar (hypoglycemia) can make you feel very hungry, dizzy, irritable, or shaky. To quickly treat hypoglycemia, eat or drink hard candy, crackers, raisins, fruit juice, or non-diet soda. Your doctor may prescribe glucagon injection in case of severe hypoglycemia.

You may get dehydrated during prolonged illness. Call your doctor if you are sick with vomiting or diarrhea, or if you eat or drink less than usual.

Glyxambi can affect the results of certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using Glyxambi.

Your treatment may also include diet, exercise, weight control, and special medical care.

Store Glyxambi.at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose of Glyxambi for Diabetes Type 2:

Initial dose: Empagliflozin 10 mg-linagliptin 5 mg orally once a day in the morning
-For patients tolerating therapy, may increase to empagliflozin 25 mg-linagliptin 5 mg once a day
Maximum dose: Empagliflozin 25 mg-linagliptin 5 mg per day

Comments:
-Not recommended in patients with type 1 diabetes mellitus as it may increase the risk of diabetic ketoacidosis in these patients.
-Has not been studied in patients with a history of pancreatitis and it is not know whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis during therapy.
-When used in combination with insulin or insulin secretagogues, a lower dose of the insulin secretagogues or insulin may be necessary to reduce the risk of hypoglycemia.

Uses:
-As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
-Empagliflozin is indicated to reduce the risk of cardiovascular death in patients with diabetes mellitus and established cardiovascular disease.

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 Glyxambi?

Avoid drinking alcohol.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Glyxambi side effects

Get emergency medical help if you have signs of an allergic reaction to Glyxambi: hives, itching, flaking or peeling skin; trouble swallowing, difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical attention right away if you have signs of a serious genital infection (penis or vagina): burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, not feeling well. These symptoms may get worse quickly.

Stop taking Glyxambi and call your doctor at once if you have:

• pain and burning when you urinate, painful urination;
• a light-headed feeling, like you might pass out;
• low blood sugar – headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky;
• heart problems – swelling, rapid weight gain, feeling short of breath; or
• dehydration – dizziness, confusion, feeling very thirsty, less urination.

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

• severe or ongoing pain in your joints;
• serious skin reaction – itching, blisters, breakdown of the outer layer of skin;
• ketoacidosis (too much acid in the blood) – nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing; or
• pancreatitis – severe pain in your upper stomach spreading to your back, nausea and vomiting.

Common Glyxambi side effects may include:

• a bladder infection; or
• cold symptoms such as runny or stuffy nose, sneezing, sore throat.

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

What other drugs will affect Glyxambi?

Other drugs may increase or decrease the effects of Glyxambi on lowering your blood sugar. Tell your doctor about all your current medicines and any you start or stop using, especially:

• insulin, or other oral diabetes medicine;
• rifampin (to treat tuberculosis); or
• a diuretic or “water pill.”

What is Glyxambi?

Glyxambi contains a combination of empagliflozin and linagliptin. Empagliflozin and linagliptin are oral diabetes medicines that help control blood sugar levels. Empagliflozin works by helping the kidneys get rid of glucose from your bloodstream. Linagliptin works by regulating the levels of insulin your body produces after eating.

Glyxambi is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Glyxambi is also used to lower the risk of death from heart attack, stroke, or heart failure in adults with type 2 diabetes who also have heart disease.

This medicine is not for treating type 1 diabetes.

Warnings

You should not use Glyxambi if you have severe kidney disease (or if you are on dialysis) or diabetic ketoacidosis, or if you have ever had a severe allergic reaction to empagliflozin or linagliptin.

Call your doctor at once if you have signs of a serious side effect, such as severe pain in your upper stomach spreading to your back, vomiting, fast heart rate, dizziness, feeling very thirsty or hot, decreased urination, heavy sweating, or hot and dry skin.

In rare cases, Glyxambi can cause serious infections in the penis or vagina. Get medical help right away if you have burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, or if you don’t feel well.

Before taking this medicine

You should not use Glyxambi if you are allergic to empagliflozin or linagliptin, or if you have:

• severe kidney disease (or if you are on dialysis);
• a history of severe allergic or skin reaction after taking empagliflozin or linagliptin; or
• diabetic ketoacidosis (call your doctor for treatment).

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

• liver or kidney disease;
• a bladder infection or urination problems;
• a pancreas disorder;
• heart failure;
• gallstones;
• a genital infection (penis or vagina);
• alcoholism, or if you currently drink large amounts of alcohol;
• if you are on a low salt diet;
• if you are 65 or older.
• if you have a planned surgery; or
• if you have high cholesterol or triglycerides.

Follow your doctor’s instructions about using Glyxambi if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy.

You should not use Glyxambi during the second or third trimester of pregnancy.

You should not breastfeed while using Glyxambi.

How should I take Glyxambi?

Take Glyxambi exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose..

Glyxambi is usually taken in the morning, with or without food.

Your blood sugar will need to be checked often, and you may also need to test the level of ketones in your urine. Empagliflozin can cause life-threatening ketoacidosis (too much acid in the blood). Even if your blood sugar is normal, contact your doctor if a urine test shows that you have high ketones in the urine.

Blood sugar can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals.

Low blood sugar (hypoglycemia) can make you feel very hungry, dizzy, irritable, or shaky. To quickly treat hypoglycemia, eat or drink hard candy, crackers, raisins, fruit juice, or non-diet soda. Your doctor may prescribe glucagon injection in case of severe hypoglycemia.

You may get dehydrated during prolonged illness. Call your doctor if you are sick with vomiting or diarrhea, or if you eat or drink less than usual.

Glyxambi can affect the results of certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using Glyxambi.

Your treatment may also include diet, exercise, weight control, and special medical care.

Store Glyxambi.at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose of Glyxambi for Diabetes Type 2:

Initial dose: Empagliflozin 10 mg-linagliptin 5 mg orally once a day in the morning
-For patients tolerating therapy, may increase to empagliflozin 25 mg-linagliptin 5 mg once a day
Maximum dose: Empagliflozin 25 mg-linagliptin 5 mg per day

Comments:
-Not recommended in patients with type 1 diabetes mellitus as it may increase the risk of diabetic ketoacidosis in these patients.
-Has not been studied in patients with a history of pancreatitis and it is not know whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis during therapy.
-When used in combination with insulin or insulin secretagogues, a lower dose of the insulin secretagogues or insulin may be necessary to reduce the risk of hypoglycemia.

Uses:
-As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
-Empagliflozin is indicated to reduce the risk of cardiovascular death in patients with diabetes mellitus and established cardiovascular disease.

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 Glyxambi?

Avoid drinking alcohol.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Glyxambi side effects

Get emergency medical help if you have signs of an allergic reaction to Glyxambi: hives, itching, flaking or peeling skin; trouble swallowing, difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical attention right away if you have signs of a serious genital infection (penis or vagina): burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, not feeling well. These symptoms may get worse quickly.

Stop taking Glyxambi and call your doctor at once if you have:

• pain and burning when you urinate, painful urination;
• a light-headed feeling, like you might pass out;
• low blood sugar – headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky;
• heart problems – swelling, rapid weight gain, feeling short of breath; or
• dehydration – dizziness, confusion, feeling very thirsty, less urination.

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

• severe or ongoing pain in your joints;
• serious skin reaction – itching, blisters, breakdown of the outer layer of skin;
• ketoacidosis (too much acid in the blood) – nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing; or
• pancreatitis – severe pain in your upper stomach spreading to your back, nausea and vomiting.

Common Glyxambi side effects may include:

• a bladder infection; or
• cold symptoms such as runny or stuffy nose, sneezing, sore throat.

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

What other drugs will affect Glyxambi?

Other drugs may increase or decrease the effects of Glyxambi on lowering your blood sugar. Tell your doctor about all your current medicines and any you start or stop using, especially:

• insulin, or other oral diabetes medicine;
• rifampin (to treat tuberculosis); or
• a diuretic or “water pill.”

What is Janumet?

Janumet contains a combination of metformin and sitagliptin. Metformin and sitagliptin are oral diabetes medicines that help control blood sugar levels.

Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines. Sitagliptin works by regulating the levels of insulin your body produces after eating.

Janumet is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Janumet is not used to treat type 1 diabetes.

Warnings

You should not use Janumet if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment with insulin).

Janumet may cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

Janumet may also lead to a serious condition called pancreatitis. Call your doctor right away if you have severe stomach pains with or without vomiting.

Before taking this medicine

You should not use Janumet if you are allergic to metformin or sitagliptin (Januvia), or if you have severe kidney disease.

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

• kidney disease (your kidney function may need to be checked before and while you are taking this medicine);
• liver disease;
• heart disease;
• pancreatitis;
• high triglycerides (a type of fat in the blood);
• gallstones; or
• alcoholism.

Some people taking metformin develop a serious condition called lactic acidosis. This may be more likely if you have liver or kidney disease, congestive heart failure, surgery, a heart attack or stroke, a severe infection, if you are 65 or older, if you are dehydrated, or if you drink a lot of alcohol. Talk with your doctor about your risk.

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking Janumet. Be sure your caregivers know ahead of time that you are using this medication.

Follow your doctor’s instructions about using Janumet if you are pregnant or you become pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy. Having high blood sugar may cause complications in both the mother and the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk. Your dose needs may also be different while you are breastfeeding.

Janumet is not approved for use by anyone younger than 18 years old.

How should I take Janumet?

Take Janumet exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take Janumet with meals.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Janumet tablets may not completely dissolve in the body. Part of the tablet may appear in your stool. This is a normal side effect of Janumet and will not make the medicine less effective.

Call your doctor if you see a tablet in your stool several times.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Janumet is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

Your blood will need to be tested often.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember (be sure to take the medicine with food). Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have severely low blood sugar (extreme weakness, nausea, tremors, sweating, confusion, trouble speaking, fast heartbeats, or seizure).

What to avoid

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.

Janumet side effects

Get emergency medical help if you have signs of an allergic reaction to Janumet: (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Stop taking this medicine and call your doctor right away if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, or fast heartbeats.

Some people develop lactic acidosis while taking metformin. Early symptoms may get worse over time and this condition can be fatal. Stop taking this medicine and get emergency medical help if you have even mild symptoms such as:

• unusual muscle pain;
• feeling cold;
• trouble breathing;
• feeling dizzy, light-headed, tired, or very weak;
• stomach pain, nausea with vomiting; or
• slow or irregular heartbeat.

Call your doctor at once if you have any of these serious side effects:

• itching, blisters, breakdown of the outer layer of skin;
• severe or ongoing pain in your joints;
• little or no urinating; or
• shortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain; or
• signs of low blood sugar, including headache, sleepiness, dizziness, sweating, feeling jittery, hunger, or fast heartbeat.

Common Janumet side effects may include:

cold symptoms such as runny or stuffy nose, sneezing, sore throat.

What is Janumet XR?

Janumet XR is a combination medicine used with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus (not for type 1 diabetes).

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

Janumet XR side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop taking Janumet XR and call your doctor right away if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, or fast heartbeats.

Some people using Janumet XR develop lactic acidosis, which can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heartbeats, dizziness, feeling cold, or feeling very weak or tired.

Call your doctor at once if you have any of these serious side effects:

• severe or ongoing pain in your joints;
• a severe skin reaction— itching, blisters, breakdown of the outer layer of skin;
• kidney problems or symptoms of heart failure–swelling, urinating less, rapid weight gain, feeling tired or short of breath; or
• severely low blood sugar–extreme weakness, confusion, tremors, sweating, fast heartbeats, trouble speaking, nausea, vomiting, rapid breathing, fainting, and seizure (convulsions).

Common side effects of Janumet XR may include:

• low blood sugar (if you also use insulin or another oral diabetes medication);
• upset stomach, indigestion, gas, diarrhea, nausea, vomiting;
• headache, weakness; or
• cold symptoms such as runny or stuffy nose, sneezing, sore throat.

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 Janumet XR if you have severe kidney disease or metabolic acidosis (including diabetic ketoacidosis).

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

Before taking this medicine

You should not use Janumet XR if you are allergic to it, or if you have severe kidney disease or metabolic acidosis (including diabetic ketoacidosis).

Tell your doctor if you have or have ever had:

• heart problems such as heart attack, heart failure, or stroke;
• pancreatitis;
• low levels of vitamin B12 or calcium in your blood;
• high triglycerides (a type of fat in the blood);
• gallstones;
• alcoholism; or
• liver or kidney disease.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking Janumet XR. Make sure that your healthcare provider knows ahead of time that you are using this medication.

It is not known if Janumet XR will harm an unborn baby. Follow your doctor’s instructions about using Janumet XR if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy.

This medicine may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk

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

How should I take Janumet XR?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Janumet XR is usually taken either once or twice a day based on the form of this medicine. Follow your doctor’s instructions.

Take Janumet XR with meals. Take the extended-release tablet once daily with your meal.

Swallow the tablet whole and do not crush, chew, or break it.

You may get dehydrated during prolonged illness. Call your doctor if you are sick with vomiting, diarrhea, fever, or if you drink liquids less than usual.

Call your doctor if you see the extended-release tablet in your stool several times.

Blood sugar can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals.

Low blood sugar (hypoglycemia) can make you feel very hungry, dizzy, irritable, or shaky. To quickly treat hypoglycemia, eat or drink hard candy, crackers, raisins, fruit juice, or non-diet soda. Your doctor may prescribe glucagon injection in case of severe hypoglycemia.

Tell your doctor if you have frequent symptoms of high blood sugar (hyperglycemia) such as increased thirst or urination. Ask your doctor before changing your medication dosage.

Your blood sugar will need to be checked on a regular basis, and you may need other medical tests including checking your kidney function.

You may be given other medications to help with your condition. Keep taking these medicines for as long as your doctor has prescribed.

Your treatment may also include diet, exercise, weight control, and special medical care.

Store at room temperature away from moisture and heat. Certain brands must be stored in the original container and used within 1 to 3 months.

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 Janumet XR?

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.

What other drugs will affect Janumet XR?

Tell your doctor about all your other medicines, especially:

• insulin or oral diabetes medicine including rosiglitazone.

Many drugs can increase your risk of lactic acidosis or affect your blood sugar and may also affect Janumet XR. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use. 

What is Jentadueto?

Jentadueto contains a combination of linagliptin and metformin. Linagliptin and metformin are oral diabetes medicines that help control blood sugar levels. Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines. Linagliptin works by regulating the levels of insulin your body produces after eating.

Jentadueto is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Warnings

You should not use Jentadueto if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment).

There may be an increased risk of developing lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

Before you take Jentadueto, tell your doctor if you have liver disease, a serious infection, heart disease, a history of pancreatitis, if you have recently had a heart attack, or if you are over 65 years old and have not recently had your kidney function checked.

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking Jentadueto.

You may develop lactic acidosis. Get emergency medical help if you have unusual muscle pain, trouble breathing, irregular heartbeats, dizziness, vomiting, or if you feel cold, tired, or very weak.

Before taking this medicine

You should not use Jentadueto if you are allergic to linagliptin (Tradjenta) or metformin, or if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment with insulin).

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

• kidney disease;
• heart disease;
• liver disease;
• gallstones;
• pancreatitis;
• alcoholism; or
• high triglycerides (a type of fat in the blood).

You may develop lactic acidosis. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking Jentadueto. Be sure your caregivers know ahead of time that you are using this medication.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor’s instructions about using Jentadueto if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

Jentadueto may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

Jentadueto is not approved for use by anyone younger than 18 years old.

How should I take Jentadueto?

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

Take Jentadueto with a meal, unless your doctor tells you otherwise.

Swallow the tablet whole and do not crush, chew, or break it.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Jentadueto is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Diabetes Type 2:

Linagliptin-metformin immediate release tablets:
-Initial dose for patients currently not receiving metformin: linagliptin 2.5 mg/metformin 500 mg orally twice a day
-Initial dose for patients currently receiving metformin: linagliptin 2.5 mg in combination with one-half of current metformin dose orally twice a day
-Initial dose for patients currently receiving linagliptin and metformin as individual components: switch to combination product containing the same doses of each component orally twice a day
Maintenance dose: Individualize dose based on safety and efficacy
Maximum dose: linagliptin 5 mg/day; metformin 2000 mg/day

Linagliptin-metformin extended-release tablets:
-Initial dose for patients currently not receiving metformin: linagliptin 5 mg/metformin extended-release 1000 mg orally once a day
-Initial dose for patients currently receiving metformin: linagliptin 5 mg in combination with a similar total daily dose of metformin orally once a day
-Initial dose for patients currently receiving linagliptin and metformin as individual components: switch to combination product containing similar doses of each component orally once a day
Maintenance dose: Individualize dose based on safety and efficacy
Maximum dose: linagliptin 5 mg/day; metformin 2000 mg/day

Comments:
-Patients taking two linagliptin 2.5 mg/metformin 1000 mg extended-release tablets should take the 2 tablets together once a day.
-When used in combination with insulin or an insulin secretagogue, a lower dose of insulin or the insulin secretagogue may be necessary to reduce the risk of hypoglycemia.

Use: To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise when treatment with both linagliptin and metformin are appropriate.

What happens if I miss a dose?

Take the medicine (with food) 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 . You may have severely low blood sugar (extreme weakness, nausea, tremors, sweating, confusion, trouble speaking, fast heartbeats, or seizure).

What to avoid

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.

Jentadueto side effects

Get emergency medical help if you have signs of an allergic reaction to Jentadueto: (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop taking this medicine and call your doctor right away if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, or fast heartbeats.

Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, fast/slow or irregular heartbeats, dizziness, feeling cold, or feeling very weak or tired.

Call your doctor at once if you have:

• a severe autoimmune reaction – itching, blisters, breakdown of the outer layer of skin;
• severe or ongoing pain in your joints; or
• symptoms of heart failure – shortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain.

Common Jentadueto side effects include:

• sore throat;
• sinus pain, stuffy nose; or
• diarrhea.

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 .

What other drugs will affect Jentadueto?

Many drugs can interact with linagliptin and metformin, making this medicine less effective or increasing your risk of lactic acidosis. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

What is Jentadueto XR?

Jentadueto XR are oral diabetes medicines that help control blood sugar levels. Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines. Linagliptin works by regulating the levels of insulin your body produces after eating.

Jentadueto XR is a combination medicine used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Jentadueto XR is not for treating type 1 diabetes.

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

Jentadueto XR side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop taking this medicine and call your doctor right away if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, or fast heartbeats.

Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, fast/slow or irregular heartbeats, dizziness, feeling cold, or feeling very weak or tired.

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

• a severe autoimmune reaction–itching, blisters, breakdown of the outer layer of skin;
• severe or ongoing pain in your joints; or
• symptoms of heart failure–shortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain.

Common side effects of Jentadueto XR may include:

• sore throat;
• sinus pain, stuffy nose; or
• diarrhea.

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 Jentadueto XR if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment).

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Get emergency medical help if you have unusual muscle pain, trouble breathing, irregular heartbeats, dizziness, vomiting, or if you feel cold, tired, or very weak.

Before taking this medicine

You should not use this medicine if you are allergic to linagliptin (Tradjenta) or metformin, or if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment with insulin).

Tell your doctor if you have ever had:

• kidney disease;
• heart disease;
• liver disease;
• pancreatitis;
• gallstones;
• alcoholism; or
• high triglycerides (a type of fat in the blood).

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking Jentadueto XR. Be sure your caregivers know ahead of time that you are using this medication.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor’s instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

This medicine may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

This medicine is not approved for use by anyone younger than 18 years old.

How should I take Jentadueto XR?

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

Take Jentadueto XR with a meal, unless your doctor tells you otherwise.

Swallow the tablet whole and do not crush, chew, or break it.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Jentadueto XR is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine (with food) 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 . You may have severely low blood sugar (extreme weakness, nausea, tremors, sweating, confusion, trouble speaking, fast heartbeats, or seizure).

What should I avoid while taking Jentadueto XR?

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.