AVANDAMET  - rosiglitazone maleate and metformin hydrochloride tablet, film coated 
Physicians Total Care, Inc.



AVANDAMET® (ah-VAN-duh-met)

(rosiglitazone maleate and metformin hydrochloride) Tablets

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, ask your doctor or pharmacist.

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

AVANDAMET may cause serious side effects, including:

New or worse heart failure

Call your doctor right away if you have any of the following:

Myocardial Infarction (“Heart Attack”)

Rosiglitazone, one of the medicines in AVANDAMET, may raise the risk of heart attack. The risk of having a heart attack may be higher in people who take AVANDAMET with insulin. Most people who take insulin should not also take AVANDAMET.

Symptoms of a heart attack can include the following:

Call your doctor or go to the nearest hospital emergency room right away if you think you are having a heart attack.

People with diabetes have a greater risk for heart problems. It is important to work with your doctor to manage other conditions, such as high blood pressure or high cholesterol.

Lactic acidosis

Metformin, one of the medicines in AVANDAMET, can cause a rare but serious condition called lactic acidosis (a build-up of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.

Most people who have had lactic acidosis with metformin have other things that, combined with the metformin, led to the lactic acidosis. Tell your doctor if you have any of the following, because you have a higher chance for getting lactic acidosis with AVANDAMET if you:

The best way to keep from having a problem with lactic acidosis from metformin is to tell your doctor if you have any of the problems in the list above. Your doctor may decide to stop your AVANDAMET for a while if you have any of these things.

Lactic acidosis can be hard to diagnose early, because the early symptoms could seem like the symptoms of many other health problems besides lactic acidosis. You should call your doctor right away if you get the following symptoms, which could be signs of lactic acidosis:

AVANDAMET can have other serious side effects. Be sure to read the section below “What are possible side effects of AVANDAMET?”.


AVANDAMET contains two prescription medicines for treating diabetes, rosiglitazone maleate (AVANDIA) and metformin hydrochloride. AVANDAMET is used, with diet and exercise, to treat certain adults with type 2 (“adult-onset” or “non-insulin dependent”) diabetes (“high blood sugar”) who are:

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. AVANDAMET may be used alone or with other diabetes medicines.

AVANDAMET is not for people with type 1 diabetes mellitus or to treat a condition called diabetic ketoacidosis.

It is not known if AVANDAMET is safe and effective in children under 18 years old.

Who should not take AVANDAMET?

Do not take AVANDAMET if you:

Many people with heart failure should not start taking AVANDAMET. See “What should I tell my doctor before taking AVANDAMET?”.

What should I tell my doctor before taking AVANDAMET?

Before starting AVANDAMET, ask your doctor about what the choices are for diabetes medicines, and what the expected benefits and possible risks are for you in particular.

Before taking AVANDAMET, tell your doctor about all your medical conditions, including if you:

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins or herbal supplements. AVANDAMET and certain other medicines can affect each other and may lead to serious side effects including high or low blood sugar, or heart problems. Your doctor may need to change your dose of AVANDAMET or your other medicines. Especially tell your doctor if you take:

Know the medicines you take. Keep a list of all your medicines and show it to your doctor and pharmacist before you start a new medicine. They will tell you if it is alright to take AVANDAMET with other medicines.

How should I take AVANDAMET?

There may be times when you will need to stop taking AVANDAMET for a short time. Tell your doctor if you:

What should I avoid while taking AVANDAMET?

Do not drink a lot of alcohol while taking AVANDAMET. 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?

AVANDAMET may cause serious side effects, including:

Common side effects of AVANDAMET include:

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store AVANDAMET?

Keep AVANDAMET and all medicines out of the reach of children.

General information about AVANDAMET

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

This Medication Guide summarizes important information about AVANDAMET. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about AVANDAMET that is written for healthcare professionals. You can also find out more about AVANDAMET by calling 1-888-825-5249.

What are the ingredients in AVANDAMET?

Active Ingredients: Rosiglitazone maleate and metformin hydrochloride

Inactive Ingredients: Hypromellose 2910, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone 29-32, 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:

AVANDAMET is a registered trademark of GlaxoSmithKline.

The other brands listed are trademarks of their respective owners and are not trademarks of GlaxoSmithKline. The makers of these brands are not affiliated with and do not endorse GlaxoSmithKline or its products.

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


Research Triangle Park, NC 27709

©2011, GlaxoSmithKline. All rights reserved.

February 2011


Revised: 8/2012
Physicians Total Care, Inc.