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AVANDIA- rosiglitazone maleate tablet, film coated


  1. Patient Information
  2. Patients Should Be Informed Of The Following:
  3. Who Should Not Take Avandia?
  4. Before Taking Avandia, Tell Your Doctor About All Your Medical Conditions, Including If You:
  5. Tell Your Doctor About All The Medicines You Take Including Prescription And Non-prescription Medicines, Vitamins Or Herbal Supplements. Avandia And Certain Other Medicines Can Affect Each Other And May Lead To Serious Side Effects Including High Or Low Blood Sugar, Or Heart Problems. Especially Tell Your Doctor If You Take:
  6. How Should I Take Avandia?
  7. Avandia May Cause Serious Side Effects Including:
  8. What Are The Ingredients In Avandia?
  9. Always Check To Make Sure That The Medicine You Are Taking Is The Correct One. Avandia Tablets Are Triangles With Rounded Corners And Look Like This:

Patient Information 

17.1Patient Advice

Patients Should Be Informed Of The Following: 

  • AVANDIA is not recommended for patients with symptoms of heart failure.
  • Patients with more severe heart failure (NYHA Class 3 or 4) cannot start AVANDIA as the risks exceed any potential benefits in such patients.
  • Results of a set of clinical studies suggest that treatment with AVANDIA is associated with an increased risk for myocardial ischemic events, such as angina or myocardial infarction (heart attack), especially in patients taking insulin or nitrates. Because this risk has not been confirmed or excluded in different long-term trials, definitive conclusions regarding this risk await completion of an adequately-designed cardiovascular outcome study.
  • AVANDIA is not recommended for patients who are taking nitrates or insulin.
  • There are multiple medications available to treat type 2 diabetes. The benefits and risks of each available diabetes medication should be taken into account when choosing a particular diabetes medication for a given patient.
  • There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with AVANDIA or any other oral antidiabetic drug.
  • Management of type 2 diabetes should include diet control. Caloric restriction, weight loss, and exercise are essential for the proper treatment of the diabetic patient because they help improve insulin sensitivity. This is important not only in the primary treatment of type 2 diabetes, but in maintaining the efficacy of drug therapy.
  • It is important to adhere to dietary instructions and to regularly have blood glucose and glycosylated hemoglobin tested. It can take 2 weeks to

    AVANDIA is a prescription medicine to treat adults with diabetes. It helps to control high blood sugar. (

    AVANDIA is a prescription medicine used with diet and exercise to treat adults with type 2 ( adult-onset or non-insulin dependent ) diabetes mellitus ( high blood sugar ). AVANDIA helps to control high blood sugar. AVANDIA may be used alone or with other diabetes medicines. AVANDIA can help your body respond better to insulin made in your body. AVANDIA does not cause your body to make more insulin.

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

Who Should Not Take Avandia? 

Many people with heart failure should not start taking AVANDIA.

Before starting AVANDIA, 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 Avandia, Tell Your Doctor About All Your Medical Conditions, Including If You: 

  • have heart problems or heart failure.
  • have type 1 ( juvenile ) diabetes or had diabetic ketoacidosis.These conditions should be treated with insulin.
  • have a type of diabetic eye disease called macular edema(swelling of the back of the eye).
  • have liver problems.Your doctor should do blood tests to check your liver before you start taking AVANDIA and during treatment as needed.
  • had liver problems while taking REZULIN(troglitazone), another medicine for diabetes.
  • are pregnant or plan to become pregnant.AVANDIA should not be used during pregnancy. It is not known if AVANDIA can harm your unborn baby. You and your doctor should talk about the best way to control your diabetes during pregnancy. If you are a premenopausal woman (before the change of life ) who does not have regular monthly periods, AVANDIA may increase your chances of becoming pregnant. Talk to your doctor about birth control choices while taking AVANDIA. Tell your doctor right away if you become pregnant while taking AVANDIA.
  • are breast-feeding or planning to breast-feed.It is not known if AVANDIA passes into breast milk. You should not use AVANDIA while breast-feeding.

Tell Your Doctor About All The Medicines You Take Including Prescription And Non-prescription Medicines, Vitamins Or Herbal Supplements. Avandia And Certain Other Medicines Can Affect Each Other And May Lead To Serious Side Effects Including High Or Low Blood Sugar, Or Heart Problems. Especially Tell Your Doctor If You Take: 

  • insulin.
  • nitrate medicinessuch as nitroglycerin or isosorbide to treat a type of chest pain called angina.
  • any medicines for high blood pressure, high cholesterol or heart failure, or for prevention of heart disease or stroke.

Know the medicines you take. Keep a list of 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 AVANDIA with other medicines.

How Should I Take Avandia? 

  • Take AVANDIA exactly as prescribed. Your doctor will tell you how many tablets to take and how often. The usual daily starting dose is 4 mg a day taken one time each day or 2 mg taken two times each day. Your doctor may need to adjust your dose until your blood sugar is better controlled.
  • AVANDIA may be prescribed alone or with other diabetes medicines. This will depend on how well your blood sugar is controlled.
  • Take AVANDIA with or without food.
  • It can take 2 weeks for AVANDIA to start lowering blood sugar. It may take 2 to 3 months to

Avandia May Cause Serious Side Effects Including: 

  • New or worse heart failure.

    • Store AVANDIA at room temperature, 59 to 86 F (15 to 30 C). Keep AVANDIA in the container it comes in.
    • Safely, throw away AVANDIA that is out of date or no longer needed.
    • Keep AVANDIA and all medicines out of the reach of children.

    General information about AVANDIA

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

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

What Are The Ingredients In Avandia? 

Active Ingredient: Rosiglitazone maleate.

Inactive Ingredients: Hypromellose 2910, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3000, sodium starch glycolate, titanium dioxide, triacetin, and 1 or more of the following: Synthetic red and yellow iron oxides and talc.

Always Check To Make Sure That The Medicine You Are Taking Is The Correct One. Avandia Tablets Are Triangles With Rounded Corners And Look Like This: 

2 mg strength tablets pink with SB on one side and 2 on the other.

4 mg strength tablets orange with SB on one side and 4 on the other.

8 mg strength tablets red-brown with SB on one side and 8 on the other.

AVANDIA is a registered trademark of GlaxoSmithKline.

REZULIN is a registered trademark of Parke-Davis Pharmaceuticals Ltd.

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

GlaxoSmithKline

Research Triangle Park, NC 27709

2008, GlaxoSmithKline. All rights reserved.

October 2008

AVD:4MG



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