Commonly Asked Questions About AVANDARYL

What is AVANDARYL?

AVANDARYL contains 2 prescription medicines to treat diabetes, rosiglitazone maleate (AVANDIA) and glimepiride (AMARYL). AVANDARYL is used with diet and exercise to treat adults with type 2 (“adult-onset” or “non-insulin dependent”) diabetes mellitus (“high blood sugar”).

Glimepiride can help your body release more of its own insulin. Rosiglitazone can help your body respond better to the insulin made in your body and does not cause your body to make more insulin. These medicines can work together to help control your blood sugar.

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

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Who should not take AVANDARYL?

Many people with heart failure should not start taking AVANDARYL (See "What should I tell my doctor before starting AVANDARYL?")

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What should I tell my doctor before starting AVANDARYL?

Before starting AVANDARYL, 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 AVANDARYL, 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 and should not be treated with AVANDARYL.
• 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 AVANDARYL and during treatment as needed.
• had liver problems while taking REZULIN^® (troglitazone), another medicine for diabetes.
• have kidney problems. If people with kidney problems use AVANDARYL, they may need a lower dose of the medication.
• have glucose 6-phosphate dehydrogenase (G6PD) deficiency. This condition runs in families. People with G6PD deficiency who take glimepiride (one of the medicines in AVANDARYL) may develop hemolytic anemia (fast breakdown of red blood cells).
• are pregnant or plan to become pregnant. AVANDARYL should not be used during pregnancy. It is not known if AVANDARYL 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 AVANDARYL may increase your chances of becoming pregnant. Talk to your doctor about birth control choices while taking AVANDARYL. Tell your doctor right away if you become pregnant while taking AVANDARYL.
• are breast-feeding or planning to breast-feed. It is not known if AVANDARYL passes into breast milk. You should not use AVANDARYL while breast-feeding.

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

• insulin.
• nitrate medicines such 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 all your medicines and show it to your doctor and pharmacist before you start a new medicine. They will tell you if it is okay to take AVANDARYL with other medicines.

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How should I take AVANDARYL?

• Take AVANDARYL exactly as prescribed. Your doctor may need to change your dose until your blood sugar is better controlled.
• Take AVANDARYL by mouth one time each day with your first main meal.
• It usually takes a few days for AVANDARYL to start lowering your blood sugar. It may take 2 to 3 months to see the full effect on your blood sugar level.
• If you miss a dose of AVANDARYL, take it as soon as you remember unless it is time to take your next dose. Take your next dose at the usual time. Do not take double doses to make up for a missed dose.
• If you take too much AVANDARYL, call your doctor or poison control center right away.
• Test your blood sugar regularly as your doctor tells you.
• Your doctor should do blood tests to check your liver before you start AVANDARYL and during treatment as needed. Your doctor should also do regular blood sugar tests (for example, "A1c") to monitor your response to AVANDARYL.
• Call your doctor if you get sick, get injured, get an infection, or have surgery. AVANDARYL may not control your blood sugar levels during these times. Your doctor may need to stop AVANDARYL for a short time and give you insulin to control your blood sugar level.

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What are possible serious side effects of AVANDARYL?

AVANDARYL may cause serious side effects, including:

• Low blood sugar (hypoglycemia). Lightheadedness, dizziness, shakiness or hunger may mean that your blood sugar is too low. This can happen if you skip meals, drink alcohol, use another medicine that lowers blood sugar, exercise (particularly hard or long), or if you have certain medical problems. Call your doctor if you have low blood sugar.
• Weight gain. AVANDARYL can cause weight gain from fluid retention or extra body fat. Weight gain can be a serious problem for people with certain conditions including heart problems. See "What is the most important information I should know about AVANDARYL?".
• Liver problems. It is important for your liver to be working normally when you take AVANDARYL. Your doctor should do blood tests to check your liver before you start taking AVANDARYL and during treatment as needed. Call your doctor right away if you have unexplained symptoms such as:
• nausea or vomiting
• stomach pain
• unusual or unexplained tiredness
• loss of appetite
• dark urine
• yellowing of your skin or the whites of your eyes.
• Macular edema (a diabetic eye disease with swelling in the back of the eye). Tell your doctor right away if you have any changes in your vision. Your doctor should check your eyes regularly. Some people have had vision changes due to swelling in the back of the eye while taking rosiglitazone, one of the medicines in AVANDARYL.
• Fractures (broken bones), usually in the hand, upper arm or foot, in females. Talk to your doctor for advice on how to keep your bones healthy.
• Low red blood cell count (anemia).
• Ovulation (release of egg from an ovary in women) leading to pregnancy. Ovulation may happen in premenopausal women who do not have regular monthly periods. This can increase the chance of pregnancy. See "What should I tell my doctor before taking AVANDARYL?". Common side effects with AVANDARYL include cold-like symptoms and headache. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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How should I store AVANDARYL?

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

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General information about AVANDARYL

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

This Medication Guide summarizes important information about AVANDARYL. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about AVANDARYL that is written for healthcare professionals. For more information, call 1-888-825-5249.

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What are the ingredients in AVANDARYL?

Active Ingredients: Rosiglitazone maleate and glimepiride.

Inactive Ingredients: Hypromellose 2910, lactose monohydrate, macrogol (polyethylene glycol) magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, triacetin, and 1 or more of the following: Yellow, red, or black iron oxides.

Always check to make sure that the medicine you are taking is the correct one. AVANDARYL tablets are triangles with rounded corners and look like this:

• 4 mg/1 mg strength tablets – yellow with “gsk” on one side and “4/1” on the other.
• 4 mg/2 mg strength tablets – orange with “gsk” on one side and “4/2” on the other.
• 4 mg/4 mg strength tablets – pink with “gsk” on one side and “4/4” on the other.
• 8 mg/2 mg strength tablets – pale pink with “gsk” on one side and “8/2” on the other.
• 8 mg/4 mg strength tablets – red with “gsk” on one side and “8/4” on the other.

AVANDARYL and AVANDIA are registered trademarks of GlaxoSmithKline.

The following are registered trademarks of their respective owners: AMARYL/AVENTIS Pharmaceuticals Inc.; REZULIN/Parke-Davis Pharmaceuticals Ltd.

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Read the Patient Information that comes with AVANDARYL before you start taking the medication 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 AVANDARYL, ask your doctor or pharmacist.