Important Information About the Side Effects of JANUMET XR

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

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

1. Lactic Acidosis. Metformin, one of the medicines in JANUMET XR, can cause a rare but serious condition called lactic acidosis (a buildup 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 JANUMET XR and call your doctor right away if you get any of the following symptoms, which could be signs of lactic acidosis.

You:

  • 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 if you:

  • have kidney problems. People whose kidneys are not working properly should not take JANUMET 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.

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 XR:

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 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.

What are the side effects of JANUMET XR?

Serious side effects have happened in people taking JANUMET XR or the individual medicines in JANUMET XR.

  • See above "What is the most important information I should know about
    JANUMET XR?".

Low blood sugar (hypoglycemia). If you take JANUMET XR 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 XR. Signs and symptoms of low blood sugar may include:

  • headache
  • drowsiness
  • weakness
  • dizziness
  • confusion
  • irritability
  • hunger
  • fast heart beat
  • sweating
  • feeling jittery

Serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking JANUMET XR and call your doctor right away. See "Who should not take JANUMET XR." Your doctor may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.

Kidney problems, sometimes requiring dialysis.

The most common side effects of JANUMET XR include:

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

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

JANUMET XR may have other side effects, including:

Swelling of the hands or legs. Swelling of the hands and legs can happen if you take JANUMET XR in combination with rosiglitazone (Avandia®). Rosiglitazone is another type of diabetes medication.

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

Tell your doctor if you have any side effect that bothers you, is unusual, or 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.

JANUMET XR can cause serious allergic reactions. See What is the most important information I should know about JANUMET XR?

The most common side effects of JANUMET XR include:

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

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