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Glucophage XR

[Metformin]


Warnings & Precautions
WARNINGS

WARNING:

A small number of people who have taken GLUCOPHAGE have developed a serious condition called lactic acidosis. Lactic acidosis is caused by a buildup of lactic acid in the blood. This happens more often in people with kidney problems. Most people with kid-ney problems should not take GLUCOPHAGE or GLUCOPHAGE XR. (See "What are the side effects of GLUCOPHAGE and GLUCOPHAGE XR?")

Who should not take GLUCOPHAGE or GLUCOPHAGE XR? Some conditions increase your chance of getting lactic acidosis, or cause other problems if you take either of these medicines. Most of the conditions listed below can increase your chance of getting lactic acidosis.

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Do not take GLUCOPHAGE or GLUCOPHAGE XR if you:

° have kidney problems

° have liver problems

° have heart failure that is treated with medicines, such as Lanoxin ® (digoxin) or Lasix ® (furosemide)

° drink a lot of alcohol. This means you binge drink for short periods or drink all the time

° are seriously dehydrated (have lost a lot of water from your body)

° are going to have an x-ray procedure with injection of dyes (contrast agents)

° are going to have surgery

° develop a serious condition, such as heart attack, severe infection, or a stroke

° are 80 years or older and you have NOT had your kidney function tested Tell your doctor if you are pregnant or plan to become pregnant. GLUCOPHAGE and GLUCOPHAGE XR may not be right for you. Talk with your doctor about your choices. You should also discuss your choices with your doctor if you are nursing a child.

Can GLUCOPHAGE or GLUCOPHAGE XR be used in children? GLUCOPHAGE has been shown to effectively lower glucose levels in children (ages 10 to 16 years) with type 2 diabetes. GLUCOPHAGE has not been studied in children younger than 10 years old. GLUCOPHAGE has not been studied in combination with other oral glucose-control medicines or insulin in children. If you have any questions about the use of GLUCOPHAGE in children, talk with your doctor or other healthcare provider.

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