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 an acid in the blood) that can cause
death. Lactic acidosis is a medical emergency and must be treated in the hospital.

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 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 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

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 XR for a while if you have any of these things.

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.

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

Before you start taking JANUMET 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
  • unusual tiredness

These may be symptoms of heart failure.

 

What are the possible 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
  • irritability
  • dizziness
  • sweating
  • weakness
  • drowsiness
  • hunger
  • confusion
  • feeling jittery
  • fast heart beat
  • 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.

  • Joint pain. Some people who take medicines called DPP-4 inhibitors, one of the medicines in JANUMET XR, 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 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 XR.

Taking JANUMET XR 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 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 medicine.

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 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
  • low blood sugar (hypoglycemia) when used in combination with certain medications, such as a sulfonylurea or insulin.
  • gas, upset stomach, indigestion
  • weakness
  • nausea and vomiting
  • headache
  • diarrhea

 
 
 

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