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Avandamet

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Avandamet

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Avandamet

Avandamet Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

ROSIGLITAZONE/METFORMIN - ORAL

(row-sih-GLIT-uh-zone/met-FOR-min)

COMMON BRAND NAME(S): Avandamet

WARNING: The rosiglitazone in this medication may infrequently cause or worsen certain heart problems (congestive heart failure, heart attack). Seek immediate medical attention if you notice any symptoms of heart problems, including: swelling of the hands/feet, unusual/sudden weight gain, trouble breathing, chest pain/discomfort.

The metformin in this combination medication can rarely cause a condition called lactic acidosis, which can be fatal. Seek immediate medical attention if you develop any of the following symptoms of lactic acidosis: unusual tiredness, severe drowsiness, cold skin, muscle pain, rapid/difficult breathing, unusually slow/irregular heartbeat.

Lactic acidosis is more likely to occur in patients who have: serious infection, surgery, kidney or liver disease, conditions that may cause a low level of oxygen in the blood or poor circulation (e.g., severe congestive heart failure, recent heart attack or stroke), excessive alcohol use, a lack of body fluids (dehydration), X-ray or scanning procedures that require an injectable iodinated contrast drug. The elderly are also at a higher risk, especially people over 80 who have not had kidney and liver tests.

USES: This combination medication is used along with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes (non-insulin-dependent diabetes). This medication works by helping to restore your body's proper response to the insulin you naturally produce.

You should only begin taking rosiglitazone/metformin when other drugs have not worked well or cannot be taken, and you do not wish to take pioglitazone-containing medications. If you are currently taking rosiglitazone/metformin and have good control of your blood sugars and no new side effects/symptoms, continue to take this medication as directed. Ask your doctor promptly about the risks and benefits of it, since a small number of people have had serious side effects (see Warning Section).

After November 18, 2011, only patients enrolled in the Avandia-Rosiglitazone Medicines Access Program may obtain and use rosiglitazone-containing products. Your doctor will need to register you with this program before you can receive your prescription. Only physicians enrolled in the Avandia-Rosiglitazone Medicines Access Program may prescribe rosiglitazone-containing products, and only certified mail-order pharmacies enrolled in the program may dispense them. Talk to your doctor or pharmacist for more details about the program.

Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Rosiglitazone belongs to a class of drugs known as thiazolidinediones or "glitazones." Metformin is a biguanide-type drug.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth, usually once or twice daily with a meal or as directed by your doctor.

The dosage is based on your medical condition and response to therapy. Taking more than 8 milligrams of rosiglitazone per day, or more than 2000 milligrams of metformin per day, is not recommended unless your doctor directs otherwise.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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