FOR U.S. RESIDENTS ONLY AGE 18 AND OVER

Why JENTADUETO?

Along with diet and exercise, JENTADUETO:

Jentadueto® (linagliptin / metformin HCI) may help lower your A1C

Can help lower
your A1C

Jentadueto can help your body produce more insulin and less sugar

Can help your body
produce more insulin
and less sugar

Offers Twice-daily dosing

HOW JENTADUETO MAY HELP

Taking JENTADUETO, along with diet and exercise, may help change the direction of your blood glucose numbers.

Even when you're doing everything you can to eat well and get enough physical activity, your numbers may not be going in the direction you and your doctor want them to. But there are ways to help, and you don't have to do it on your own.

JENTADUETO® (linagliptin/metformin HCI) tablets is a prescription medicine that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

JENTADUETO is a twice-daily pill that, when used along with diet and exercise, can help lower blood sugar in adults with type 2 diabetes. It's a combination prescription medication that contains two diabetes medicines, linagliptin and metformin.

Managing your blood sugar may help you to reach your target A1C – and that's an important goal for adults with type 2 diabetes.

JENTADUETO is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine). If you have had inflammation of the pancreas (pancreatitis) in the past, it is not known if you have a higher chance of getting pancreatitis while you take JENTADUETO.

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HOW JENTADUETO Works

JENTADUETO helps lower blood sugar in 3 ways:

  • By increasing hormones that stimulate your pancreas to produce more insulin
  • By increasing hormones that stimulate your liver to produce less glucose
  • By helping your body use insulin more effectively

JENTADUETO belongs to two classes of drugs: DPP-4 inhibitors and biguanides. DPP-4 inhibitors work by increasing hormones that stimulate your pancreas to produce more insulin and stimulate your liver to produce less glucose. Biguanides work by reducing the amount of glucose in your blood and by increasing insulin sensitivity.

The two medicines together, along with diet and exercise, can help your body produce more insulin, and less sugar. Managing your sugar can mean a lower A1C – and that's an important goal for anyone with type 2 diabetes.

TAKING JENTADUETO Every Day


TWICE A DAY

Take JENTADUETO exactly as your doctor tells you to take it.

TAKE WITH MEALS

Take JENTADUETO two times each day with meals to lower your chance of stomach upset.

Do not double dose
DON'T DOUBLE DOSE

If you miss a dose, take it with a meal when you remember, or skip it until your next scheduled dose.

Be aware:

  • If you take too much JENTADUETO, call your doctor or Poison Control Center at 1-800-222-1222 or go to the nearest hospital emergency room right away
  • Your doctor may tell you to take JENTADUETO along with other diabetes medicines. Low blood sugar can happen more often when JENTADUETO is taken with certain other diabetes medicines. Tell your doctor if you take another medicine that can cause low blood sugar, such as sulfonylurea or insulin. The dose of your sulfonylurea or insulin may need to be lowered while you take JENTADUETO
  • You may need to stop taking JENTADUETO for a short time. Call your doctor for instructions if you:
    • are dehydrated (have lost too much body fluid). Dehydration can occur if you are sick with severe vomiting, diarrhea, or fever, or if you drink a lot less liquid than normal
    • plan to have surgery
    • are going to get an injection of dye or contrast agent for an x-ray procedure
  • When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine that you need may change. Tell your doctor right away if you have any of these conditions and follow your doctor's instructions
  • Check your blood sugar as your doctor tells you to
  • Stay on your prescribed diet and exercise program while taking JENTADUETO
  • Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and hemoglobin A1C
  • Your doctor will do blood tests to check how well your kidneys are working before and during your treatment with JENTADUETO
  • Store JENTADUETO at 68°F to 77°F (20°C to 25°C)
  • Keep JENTADUETO tablets dry
  • Keep JENTADUETO and all medicines out of the reach of children

JENTADUETO is not for everyone.

Do not take JENTADUETO if you:
  • have kidney problems
  • have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine)
  • are allergic to linagliptin, metformin, or any of the ingredients in JENTADUETO

Symptoms of an allergic reaction may include rash, itching, flaking or peeling of your skin; raised red patches on your skin (hives); and swelling of your face, lips, tongue and throat that may cause difficulty breathing or swallowing. If you have any symptoms of a serious allergic reaction, stop taking JENTADUETO and call your doctor or go to the emergency room right away.

What are JENTADUETO and JENTADUETO XR?

JENTADUETO and JENTADUETO XR are prescription medicines that contains 2 diabetes medicines, linagliptin and metformin. JENTADUETO and JENTADUETO XR can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes when treatment with both linagliptin and metformin is appropriate.

JENTADUETO and JENTADUETO XR are not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine). If you have had inflammation of the pancreas (pancreatitis) in the past, it is not known if you have a higher chance of getting pancreatitis while you take JENTADUETO or JENTADUETO XR.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about JENTADUETO or JENTADUETO XR?

JENTADUETO and JENTADUETO XR can cause serious side effects, including Lactic Acidosis (a build-up of lactic acid in the blood). Metformin, one of the medicines in JENTADUETO and JENTADUETO XR, can cause lactic acidosis, a rare but serious condition that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.

Call your doctor right away if you get any of the following symptoms, which could be signs of lactic acidosis: feel cold in your hands or feet, feel dizzy or lightheaded, have a slow or irregular heartbeat, feel very weak or tired, have unusual muscle pain, have trouble breathing, feel sleepy or drowsy, have stomach pains, nausea, or vomiting.

You have a higher chance of getting lactic acidosis with JENTADUETO or JENTADUETO XR if you have severe kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye, liver problems, drink alcohol very often, or drink a lot of alcohol in short term (“binge” drinking), get dehydrated (lose a large amount of body fluids), have surgery, have a heart attack, severe infection, or stroke.

Inflammation of the pancreas (pancreatitis) is another serious side effect that can happen to people taking JENTADUETO or JENTADUETO XR. Pancreatitis may be severe and lead to death. Before you start taking JENTADUETO or JENTADUETO XR tell your doctor if you have ever had pancreatitis, gallstones, a history of alcoholism, or high triglyceride levels.

Stop taking JENTADUETO or JENTADUETO XR and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

Heart failure. Heart failure means your heart does not pump blood well enough. Before you start taking JENTADUETO or JENTADUETO XR, tell your doctor if you have ever had heart failure or have problems with your kidneys. Contact your doctor right away if you have any of the following symptoms: increasing shortness of breath or trouble breathing, especially when you lie down; swelling or fluid retention, especially in the feet, ankles, or legs; an unusually fast increase in weight or unusual tiredness. These may be symptoms of heart failure.

Who should not take JENTADUETO or JENTADUETO XR?

Do not take JENTADUETO or JENTADUETO XR if you:

What should I tell my doctor before using JENTADUETO or JENTADUETO XR?

Tell your doctor about all of your medical conditions, including if you:

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. JENTADUETO or JENTADUETO XR may affect the way other medicines work, and other medicines may affect how JENTADUETO or JENTADUETO XR works.

Especially tell your doctor if you take:

*These trademarks are owned by third parties not affiliated with JENTADUETO or JENTADUETO XR.

What are the possible side effects of JENTADUETO and JENTADUETO XR?

JENTADUETO and JENTADUETO XR may cause serious side effects, including:

The most common side effects of JENTADUETO and JENTADUETO XR include stuffy or runny nose, sore throat, and diarrhea.

These are not all the possible side effects of JENTADUETO and JENTADUETO XR. For more information, ask your doctor or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑10881‑800‑FDA‑1088.

CL-JD-100001 8.21.17

Please see Prescribing Information, including Boxed Warning about lactic acidosis, and Medication Guide for JENTADUETO.
Please see Prescribing Information, including Boxed Warning about lactic acidosis, and Medication Guide for JENTADUETO XR.

What are JENTADUETO and JENTADUETO XR?

JENTADUETO and JENTADUETO XR are prescription medicines that contains 2 diabetes medicines, linagliptin and metformin. JENTADUETO and JENTADUETO XR can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes when treatment with both linagliptin and metformin is appropriate.

JENTADUETO and JENTADUETO XR are not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine). If you have had inflammation of the pancreas (pancreatitis) in the past, it is not known if you have a higher chance of getting pancreatitis while you take JENTADUETO or JENTADUETO XR.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about JENTADUETO or JENTADUETO XR?

JENTADUETO and JENTADUETO XR can cause serious side effects, including Lactic Acidosis (a build-up of lactic acid in the blood). Metformin, one of the medicines in JENTADUETO and JENTADUETO XR, can cause lactic acidosis, a rare but serious condition that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.

Call your doctor right away if you get any of the following symptoms, which could be signs of lactic acidosis: feel cold in your hands or feet, feel dizzy or lightheaded, have a slow or irregular heartbeat, feel very weak or tired, have unusual muscle pain, have trouble breathing, feel sleepy or drowsy, have stomach pains, nausea, or vomiting.

You have a higher chance of getting lactic acidosis with JENTADUETO or JENTADUETO XR if you have severe kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye, liver problems, drink alcohol very often, or drink a lot of alcohol in short term (“binge” drinking), get dehydrated (lose a large amount of body fluids), have surgery, have a heart attack, severe infection, or stroke.

Inflammation of the pancreas (pancreatitis) is another serious side effect that can happen to people taking JENTADUETO or JENTADUETO XR. Pancreatitis may be severe and lead to death. Before you start taking JENTADUETO or JENTADUETO XR tell your doctor if you have ever had pancreatitis, gallstones, a history of alcoholism, or high triglyceride levels.

Stop taking JENTADUETO or JENTADUETO XR and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

Heart failure. Heart failure means your heart does not pump blood well enough. Before you start taking JENTADUETO or JENTADUETO XR, tell your doctor if you have ever had heart failure or have problems with your kidneys. Contact your doctor right away if you have any of the following symptoms: increasing shortness of breath or trouble breathing, especially when you lie down; swelling or fluid retention, especially in the feet, ankles, or legs; an unusually fast increase in weight or unusual tiredness. These may be symptoms of heart failure.

Who should not take JENTADUETO or JENTADUETO XR?

Do not take JENTADUETO or JENTADUETO XR if you:

What should I tell my doctor before using JENTADUETO or JENTADUETO XR?

Tell your doctor about all of your medical conditions, including if you:

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. JENTADUETO or JENTADUETO XR may affect the way other medicines work, and other medicines may affect how JENTADUETO or JENTADUETO XR works.

Especially tell your doctor if you take:

*These trademarks are owned by third parties not affiliated with JENTADUETO or JENTADUETO XR.

What are the possible side effects of JENTADUETO and JENTADUETO XR?

JENTADUETO and JENTADUETO XR may cause serious side effects, including:

The most common side effects of JENTADUETO and JENTADUETO XR include stuffy or runny nose, sore throat, and diarrhea.

These are not all the possible side effects of JENTADUETO and JENTADUETO XR. For more information, ask your doctor or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑10881‑800‑FDA‑1088.

CL-JD-100001 8.21.17

Please see Prescribing Information, including Boxed Warning about lactic acidosis, and Medication Guide for JENTADUETO.
Please see Prescribing Information, including Boxed Warning about lactic acidosis, and Medication Guide for JENTADUETO XR.