Selected Risk Information About JANUMET XR

Metformin, one of the ingredients in 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 XR and call your doctor right away if you get any of the following symptoms 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; or have a slow or irregular heartbeat.

You have a higher chance of getting lactic acidosis if you have kidney problems, liver problems, or congestive heart failure that requires treatment with medicines; if you drink alcohol very often, drink a lot of alcohol in a short period of time, or get dehydrated (lose large amounts of body fluids); if you have certain x-ray tests with dyes or contrast agents that are injected into your body; or if you have surgery, a heart attack, severe infection, or stroke.

Pancreatitis is another serious side effect that can happen in people taking JANUMET XR. Pancreatitis may be severe and lead to death. Before you start taking JANUMET XR, tell your doctor if you've ever had pancreatitis. 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.

Do not take JANUMET XR if you are allergic to any of the ingredients in JANUMET XR. Allergic reactions, which may be serious, including rash; hives; and 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 XR and call your doctor right away.

Do not take JANUMET XR if your kidneys are not working properly. Your doctor will do blood tests before and during your treatment with JANUMET XR to see how well your kidneys are working.

If you take 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, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, and feeling jittery.

Kidney problems, sometimes requiring dialysis, have been reported.

Common side effects when taking JANUMET XR include stuffy or runny nose and sore throat, upper respiratory tract infection, diarrhea, nausea and vomiting, gas, upset stomach, indigestion, weakness, and headache.

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 Medication Guide for JANUMET XR, including the information about lactic acidosis, and discuss it with your doctor. The physician Prescribing Information also is available.

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