Important Information About the Possible Side Effects of JANUMET

What is the most important information I should know about JANUMET?

JANUMET can cause serious side effects, including:

1.

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

Stop taking JANUMET and call your doctor right away if you have any of the following symptoms, which could be signs of lactic acidosis:

  • you feel cold in your hands or feet
  • you feel dizzy or lightheaded
  • you have a slow or irregular heartbeat
  • you feel very weak or tired
  • you have unusual (not normal) muscle pain
  • you have trouble breathing
  • you feel sleepy or drowsy
  • you have stomach pains, nausea or vomiting

Most people who have had lactic acidosis with metformin have other things that, combined with the metformin, led to the lactic acidosis. Tell your doctor if you have any of the following, because you have a higher chance for getting lactic acidosis with JANUMET if you:

  • have severe kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye
  • have 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). 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 surgery
  • have a heart attack, severe infection, or stroke
  • are 65 years of age or older

The best way to keep from having a problem with lactic acidosis from metformin is to tell your doctor if you have any of the problems in the list above. Your doctor may decide to stop your JANUMET for a while if you have any of these things.

The best way to keep from having a problem with lactic acidosis from metformin is to tell your doctor if you have any of the problems in the list above. Your doctor may decide to stop your JANUMET for a while if you have any of these things.

JANUMET can have other serious side effects. See “What are the possible side effects of JANUMET?”

JANUMET can have other serious side effects. See “What are the possible side effects of JANUMET?”

2.

2.Pancreatitis (inflammation of the pancreas) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis.

Before you start taking JANUMET, tell your doctor if you have ever had:

  • pancreatitis
  • stones in your gallbladder (gallstones)
  • a history of alcoholism
  • high blood triglyceride levels

Stop taking JANUMET 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.

3.

3.Heart failure. Heart failure means that your heart does not pump blood well enough.

Before you start taking JANUMET, 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
  • unusual tiredness

These may be symptoms of heart failure.

Who should not take JANUMET?

Do not take JANUMET if you:

  • have severe kidney problems.
  • have diabetic ketoacidosis.
  • are allergic to any of the ingredients in JANUMET. See the end of the Medication Guide for a complete list of ingredients in JANUMET.

Symptoms of a serious allergic reaction to JANUMET may include rash, raised red patches on your skin (hives) or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.

Other Possible Side Effects

What are the possible side effects of JANUMET?

JANUMET may cause serious side effects, including:

  • See above section: "What is the most important information I should know about JANUMET?"
  • Kidney problems, sometimes requiring dialysis.
  • Low vitamin B12 (vitamin B12 deficiency). Using metformin for long periods of time may cause a decrease in the amount of vitamin B12 in your blood, especially if you have had low vitamin B12 blood levels before. Your doctor may do blood tests to check your vitamin B12 levels.
  • Low blood sugar (hypoglycemia). If you take JANUMET with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you use JANUMET. Signs and symptoms of low blood sugar may include:
    • headache
    • drowsiness
    • irritability
    • hunger
    • dizziness
    • confusion
    • sweating
    • feeling jittery
    • weakness
    • fast heart beat
  • Serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking JANUMET and call your doctor right away or get emergency medical help. See above section: "Who should not take JANUMET?". Your doctor may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.
  • Joint pain. Some people who take medicines called DPP-4 inhibitors, one of the medicines in JANUMET, may develop joint pain that can be severe. Call your doctor if you have severe joint pain.
  • Skin reaction. Some people who take medicines called DPP-4 inhibitors, one of the medicines in JANUMET, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your doctor right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your doctor may tell you to stop taking JANUMET.

The most common side effects of JANUMET include:

  • stuffy or runny nose and sore throat
  • gas, upset stomach, indigestion
  • headache
  • upper respiratory infection
  • weakness
  • diarrhea
  • lower blood sugar (hypoglycemia) when used in combination with certain medicines, such as a sulfonylurea or insulin
  • nausea and vomiting

Taking JANUMET with meals can help lessen the common stomach side effects of metformin that usually happen at the beginning of treatment. If you have unusual or sudden stomach problems, talk with your doctor. Stomach problems that start later during treatment may be a sign of something more serious.

JANUMET may have other side effects, including swelling of the hands or legs. Swelling of the hands and legs can happen if you take JANUMET in combination with rosiglitazone (Avandia®). Rosiglitazone is another type of diabetes medicine

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

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

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


Indication for JANUMET and JANUMET XR

JANUMET tablets contain 2 prescription medicines: sitagliptin (JANUVIA®) and metformin. Once-daily prescription JANUMET XR tablets contain sitagliptin (the medicine in JANUVIA®) and extended-release metformin.

JANUMET or JANUMET XR can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

JANUMET or JANUMET XR should not be used in patients with type 1 diabetes. If you have had pancreatitis (inflammation of the pancreas), it is not known if you have a higher chance of getting it while taking JANUMET or JANUMET XR.

Important Safety Information for JANUMET and JANUMET XR

Metformin, one of the medicines in JANUMET and JANUMET XR, can cause a rare but serious side effect called lactic acidosis (a buildup of lactic acid in the blood), which can cause death. Lactic acidosis is a medical emergency that must be treated in a hospital. Stop taking JANUMET or JANUMET XR and 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 (not normal) muscle pain; have trouble breathing; feel sleepy or drowsy; have stomach pains, nausea, or vomiting.

Most people who have had lactic acidosis with metformin have other things that, combined with the metformin, led to the lactic acidosis. Tell your doctor if you have any of the following, because you have a higher chance of getting lactic acidosis with JANUMET or JANUMET XR if you: have severe kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye; have liver problems; drink alcohol very often, or drink a lot of alcohol in short-term “binge” drinking; get dehydrated (lose large amounts of body fluids, which may happen if you are sick with fever, vomiting, or diarrhea; if you sweat a lot with activity or exercise and do not drink enough fluids); have surgery; have a heart attack, severe infection, stroke, or are 65 years of age or older. Your doctor may decide to stop your JANUMET or JANUMET XR for a while if you have any of these things.

Pancreatitis (inflammation of the pancreas) is another serious side effect that can happen in people taking JANUMET or JANUMET XR. Pancreatitis may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis. Before you start taking JANUMET or JANUMET XR, tell your doctor if you’ve ever had pancreatitis. Stop taking JANUMET or JANUMET 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.

Before you start taking JANUMET or JANUMET XR, tell your doctor if you have ever had heart failure (your heart does not pump blood well enough) or have problems with your kidneys. Contact your doctor right away if you have 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.

Do not take JANUMET or JANUMET XR if you have severe kidney problems or have diabetic ketoacidosis. Your doctor will do blood tests before and during your treatment to see how well your kidneys are working.

Do not take JANUMET or JANUMET XR if you are allergic to any of the ingredients in JANUMET or JANUMET XR. Allergic reactions, which may be serious, including rash; hives; or swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, can occur. If you have an allergic reaction, stop taking JANUMET or JANUMET XR and call your doctor right away or get emergency medical help.

Tell your doctor if you are going to get an injection of dye or contrast agent for an x-ray procedure; JANUMET or JANUMET XR may need to be stopped for a short time.

Kidney problems, sometimes requiring dialysis, have been reported.

Low vitamin B12 (vitamin B12 deficiency). Using metformin for long periods of time may cause a decrease in the amount of vitamin B12 in your blood, especially if you have had low vitamin B12 blood levels before. Your doctor may do blood tests to check your vitamin B12 levels.

If you take JANUMET or JANUMET XR with another medicine that can cause low blood sugar (hypoglycemia), such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea or insulin may need to be lowered. Signs and symptoms of low blood sugar may include headache, drowsiness, irritability, hunger, dizziness, confusion, sweating, feeling jittery, weakness, and fast heartbeat.

Some people who take medicines called DPP-4 inhibitors, one of the medicines in JANUMET and JANUMET XR, may develop joint pain that can be severe. Call your doctor if you have severe joint pain.

Some people who take medicines called DPP-4 inhibitors, one of the medicines in JANUMET and JANUMET XR, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your doctor right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your doctor may tell you to stop taking JANUMET or JANUMET XR.

Common side effects when taking JANUMET or JANUMET XR include stuffy or runny nose and sore throat, gas, upset stomach, indigestion, headache, upper respiratory tract infection, weakness, diarrhea, low blood sugar (hypoglycemia) when used in combination with certain medicines such as sulfonylurea or insulin, nausea and vomiting.

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

Please read the accompanying Medication Guide for JANUMET® (sitagliptin and metformin HCl) tablets or JANUMET® XR (sitagliptin and metformin HCl extended-release) tablets, including the information about lactic acidosis, and discuss it with your doctor. The physician Prescribing Information for JANUMET or JANUMET XR also is available.

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