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JANUMET (METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE) TABLETS: MOST IMPORTANT INFORMATION

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

Serious side effects can happen in people taking Janumet, including:

Lactic Acidosis.

Metformin, one of the medicines in Janumet, 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 Janumet and call your doctor right away if you get any of the following symptoms, which could be signs of lactic acidosis:

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

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

  • have liver problems.
  • have kidney problems. People whose kidneys are not working properly should not take Janumet.
  • drink alcohol very often, or drink a lot of alcohol in short-term "binge" drinking.
  • have congestive heart failure that requires treatment with medicines.
  • 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 certain x-ray tests with dyes or contrast agents that are injected into your body.
  • are 80 years of age or older and have not had your kidneys tested.
  • have a heart attack, severe infection, or stroke.

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

    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.



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