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AVANDAMET (METFORMIN HYDROCHLORIDE, ROSIGLITAZONE MALEATE) TABLETS: MEDICATION GUIDE

Read this Medication Guide carefully before you start taking AvandaMet and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about AvandaMet tablets, ask your doctor or pharmacist.


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


What is AvandaMet?

AvandaMet contains two prescription medicines for treating diabetes, rosiglitazone maleate (Avandia) and metformin hydrochloride. AvandaMet is used, with diet and exercise, to treat adults with type 2 ("adult-onset" or "non-insulin dependent") diabetes ("high blood sugar"). Metformin works mainly by decreasing the production of sugar by your liver. Rosiglitazone helps your body respond better to its natural insulin and does not cause your body to make more insulin. These medicines work together to help control your blood sugar. This medication may be used alone or with other diabetes medicines.

  • For AvandaMet to work best, it is very important to exercise, lose extra weight, and follow the diet recommended by your doctor.
  • This medication has not been studied enough in children under 18 years of age to know if it is safe or effective in children.
  • AvandaMet (Rosiglitazone, Metformin HCl) tablets are not for people with type 1 diabetes mellitus or to treat a condition called diabetic ketoacidosis.


    Who should not take AvandaMet?

    Do not take this drug if you:

  • have kidney problems. Before you take AvandaMet (Rosiglitazone, Metformin Hydrochloride) and while you take it, your doctor should test your blood to check for signs of kidney problems.
  • have a condition known as metabolic acidosis, including diabetic ketoacidosis.
  • are going to have an x-ray procedure with an injection of dyes (contrast agents) in your vein with a needle. Talk to your doctor about when to stop AvandaMet and when to start it again.

    Many people with heart failure should not start taking this medicine. See "What should I tell my doctor before taking AvandaMet".


    What should I tell my doctor before taking AvandaMet?


    How should I take AvandaMet?


    What should I avoid while taking AvandaMet?

    Do not drink a lot of alcohol while taking AvandaMet (Rosiglitazone and Metformin HCl). This means you should not "binge drink", and you should not drink a lot of alcohol on a regular basis. Drinking a lot of alcohol can increase the chance of getting lactic acidosis.


    What are possible side effects of AvandaMet?


    How should I store AvandaMet?

  • Store this medication at room temperature, 59° to 86°F (15° to 30°C).
  • Keep AvandaMet (Rosiglitazone and Metformin Hydrochloride) in the container it comes in. Keep the container closed tightly.
  • Safely, throw away AvandaMet that is out of date or no longer needed.

    Keep this drug and all medicines out of the reach of children.


    General information about AvandaMet (Rosiglitazone and Metformin Hydrochloride) tablets

    Medicines are sometimes prescribed for purposes other than those listed in a Patient Medication Guide. Do not use AvandaMet for a condition for which it was not prescribed. Do not give this medicine to other people, even if they have the same symptoms you have. It may harm them.

    This Medication Guide summarizes important information about AvandaMet (Rosiglitazone Maleate and Metformin). If you would like more information, talk with your doctor. You can ask your doctor, pharmacist, or other healthcare professional for information about AvandaMet that is written for healthcare professionals.


    What are the ingredients in AvandaMet?

    Active Ingredients: Rosiglitazone Maleate and Metformin Hydrochloride

    Inactive Ingredients: lactose monohydrate, hypromellose 2910, magnesium stearate, microcrystalline cellulose, povidone 29-32, polyethylene glycol 400, sodium starch glycolate, titanium dioxide, and 1 or more of the following: red and yellow iron oxides.

    Always check to make sure that the medicine you are taking is the correct one. AvandaMet tablets are oval and look like this:

  • 2 mg/500 mg strength tablets - pale pink, printed with "GSK" on one side and "2/500" on the other.
  • 4 mg/500 mg strength tablets - orange, printed with "GSK" on one side and "4/500" on the other
  • 2 mg/1,000 mg strength tablets - yellow, printed with "GSK" on one side and "2/1000" on the other
  • 4 mg/1,000 mg strength tablets - pink, printed with "GSK" on one side and "4/1000" on the other

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    Manufactured and distributed by GlaxoSmithKline pharmaceutical company and its divisions.

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