Jentadueto XR

Jentadueto XR is a prescription medication used to treat type 2 diabetes in adults. Jentadueto XR is a tablet containing two prescription drugs, linagliptin and metformin. Linagliptin belongs to a group of drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors, which help lower blood sugar levels. Metformin belongs to a group of drugs called biguanides, which decrease the amount of sugar made by the liver and help cells to respond to insulin.

This medication is available as an extended-release tablet and is to be taken once a day with a meal. Do not split, crush, dissolve or chew tablets. Swallow tablets whole.

Common side effects of Jentadueto XR include stuffy nose, sore throat, and diarrhea.

Jentadueto XR is a prescription medicine that contains 2 diabetes medicines, linagliptin and metformin. It can be used along with diet and exercise to help control blood sugar in adults with type 2 diabetes.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Boehringer Ingelheim

• Eli Lilly and Company

Jentadueto XR may cause serious side effects. See "Drug Precautions".

The most common side effects of Jentadueto XR include:

• stuffy or runny nose
• sore throat
• diarrhea

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

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other medicines that can lower your blood sugar
• topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide)
• alcohol
• medications that affect how metformin exits the body such as cimetidine
• medications that increase the activity of the enzyme CYP3A4 such as rifampin
• medications that affect glycemic (sugar) control such as thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid

This is not a complete list of Jentadueto XR drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects can happen in people taking Jentadueto XR, including:

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

Stop taking Jentadueto XR and call your doctor right away if you get any of the following symptoms of lactic acidosis:

• feel very weak or tired
• have unusual (not normal) muscle pain
• have trouble breathing
• have unusual sleepiness or sleep longer than usual
• have sudden stomach or intestinal problems with nausea and vomiting or diarrhea
• feel cold, especially in your arms and legs
• feel dizzy or lightheaded
• have a slow or irregular heartbeat

You have a higher chance of getting lactic acidosis with Jentadueto XR if you:

• have kidney problems. People whose kidneys are not working properly should not take Jentadueto XR.
• have liver problems
• have congestive heart failure that requires treatment with medicines
• drink alcohol very often, or drink a lot of alcohol in short-term ("binge" drinking)
• get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids.
• have certain x-ray tests with dyes or contrast agents that are injected into your body
• have surgery
• have a heart attack, severe infection, or stroke
• are 80 years of age or older and have not had your kidneys tested

2. Low blood sugar (hypoglycemia). If you take Jentadueto XR with another medication that can cause low blood sugar, such as sulfonylureas or insulin, you have a higher risk of having low blood sugar. Tell your doctor if you take other diabetes medicines. If you have symptoms of low blood sugar, you should check your blood sugar and treat it if it is low; then call your doctor. Symptoms of low blood sugar include:

• shaking
• sweating
• rapid heartbeat
• change in vision
• hunger
• headache
• change in mood

3. Severe and persistent joint pain. If you experience severe and persistent joint pain, contact your doctor right away. Do not stop taking your medication. Your doctor will decide if your medication is the possible cause of severe joint pain and will discontinue the drug if appropriate.

4. Inflammation of the pancreas (pancreatitis).

5. Allergic (hypersensitivity) reactions. Serious allergic reactions can happen after your first dose or up to 3 months after starting this medication. If you have any of the following symptoms, stop taking this medication and call your healthcare provider and go to the nearest emergency room immediately. 

• face, lips, throat swelling
• swelling of other areas on your skin
• difficulty swallowing
• difficulty breathing
• raised, red areas on your skin (hives)
• skin rash
• itching, flaking, or peeling of your skin

Do not take Jentadueto XR 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 XR.

Symptoms of a serious allergic reaction to Jentadueto XR are:

• rash
• raised red patches on your skin (hives)
• swelling of your face, lips, and throat that may cause difficulty breathing or swallowing

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Jentadueto XR, there are no specific foods that you must exclude from your diet when receiving this medication.

Before you take Jentadueto XR, tell your doctor if you:

• are allergic to linagliptin, metformin hydrochloride, or to any of its ingredients
• have or have had inflammation of your pancreas
• have kidney problems
• are going to get an injection of dye or contrast agents for an x-ray procedure. Linagliptin/metformin will need to be stopped for a short time. Talk to your doctor about when you should stop Jentadueto XR and when you should start Jentadueto XR again. 
• have liver problems
• have heart problems, including congestive heart failure
• drink alcohol very often, or drink a lot of alcohol in short term "binge" drinking
• have any other medical conditions
• have type 1 diabetes. This medication is not to be used to treat type 1 diabetes. 
• are a premenopausal woman (before the “change of life”) and who does not have periods regularly or at all. Speak with your healthcare provider about your birth control options while taking this medication. This is especially true if you are not planning to become pregnant since this medication may increase your chance of becoming pregnant. 
• are pregnant or planning to become pregnant. It is not known if Jentadueto XR will harm your unborn baby. If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant.
• are breastfeeding or plan to breastfeed. It is not known if Jentadueto XR passes into your breast milk. Talk with your doctor about the best way to feed your baby if you take Jentadueto XR.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

It is not known if this medication will harm your unborn baby. There is not enough data to say if this medication can lead to major birth defects or miscarriage. 

However, there are risks to the mother and baby if blood sugar is not controlled. Your doctor will determine the best way to manage your diabetes. 

Tell your doctor if you are breastfeeding or plan to breastfeed. 

It is not known if Jentadueto XR crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Jentadueto XR.

Take Jentadueto XR exactly as your doctor tells you to take it.

• Take Jentadueto XR once daily with a meal. Taking Jentadueto XR with a meal may lower your chance of having an upset stomach.
• Take tablets whole. Do not break, cut, crush, dissolve, or chew Jentadueto XR tablets before swallowing. If you cannot swallow tablets whole, tell your doctor.
• You may see something that looks like the Jentadueto XR tablet in your stool. If you see tablets in your stool, tell your healthcare provider. Do not stop taking your medicine without talking to your doctor.
• Your doctor will tell you how much Jentadueto XR to take and when to take it.
• If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take 2 doses of Jentadueto XR at the same time.
• Your doctor may tell you to take Jentadueto XR along with other diabetes medicines. Low blood sugar can happen more often when Jentadueto XR is taken with certain other diabetes medicines.
• You may need to stop taking Jentadueto XR 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 fluid 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.
• Talk to your doctor about how to prevent, recognize, and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and complications of diabetes.
• Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.
• Your doctor will do blood tests to check how well your kidneys are working before and during your treatment with Jentadueto XR.

Take Jentadueto exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends will be based on the following: 

• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your kidney function

The recommended dose range of Jentadueto XR for the treatment of type 2 diabetes in adults is 5 mg linagliptin/1000 mg metformin hydrochloride to a maximum dose of 5 mg linagliptin/2000 mg metformin hydrochloride.

If you take too much Jentadueto XR, call your doctor, or go to the nearest hospital emergency room right away.

• Store Jentadueto XR at at 25°C (77°F).
• Keep tablets dry.
• Keep Jentadueto XR and all medicines out of the reach of children.

WARNING: RISK OF LACTIC ACIDOSIS

Lactic acidosis is a rare, but serious, complication that can occur due to metformin accumulation. The risk increases with conditions such as renal impairment, sepsis, dehydration, excess alcohol intake, hepatic impairment, and acute congestive heart failure.

The onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress.

Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate.

If acidosis is suspected, Jentadueto XR should be discontinued and the patient hospitalized immediately.