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AVANDIA (rosiglitazone maleate) is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity, to treat type 2 diabetes in certain patients.

AVANDIA (Rosiglitazone) is used for:

Controlling blood sugar levels, along with diet and exercise, in patients with type 2 diabetes. This medication may also be used with other antidiabetes medicines.

Rosiglitazone is a thiazolidinedione. It lowers blood glucose (sugar) by making the cells of the body more sensitive to the action of insulin. Insulin is needed to allow sugar to be carried from the bloodstream into many cells of the body for energy. Rosiglitazone does not work in type 1 diabetes.

Do NOT use AVANDIA (Rosiglitazone) if:

• you are allergic to any ingredient in Rosiglitazone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Rosiglitazone :

Some medical conditions may interact with AVANDIA (Rosiglitazone). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have diabetic ketoacidosis, type 1 diabetes, swelling problems (edema), or liver disease
• if you have experienced liver problems, including yellowing of the skin, with troglitazone
• if you have a history of heart disease (eg, chronic congestive heart failure)

Some MEDICINES MAY INTERACT with AVANDIA (Rosiglitazone). Tell your health care provider if you are taking any other medicines, especially any of the following:

• Rifampin because the effectiveness of AVANDIA (Rosiglitazone) may be decreased
• Gemfibrozil because actions and side effects of Rosiglitazone may be increased and excessively low blood sugar may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Rosiglitazone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use AVANDIA (Rosiglitazone):

Use Rosiglitazone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Rosiglitazone may be taken with or without food. Take with food if stomach upset occurs.
• To help you remember to take Rosiglitazone , you may want to take it at the same time every day.
• Full effects of Rosiglitazone may not be seen for 2 to 3 months.
• If you miss a dose of Rosiglitazone , take it as soon as possible. If it almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double the dose.

Ask your health care provider any questions you may have about how to use Rosiglitazone.

Important safety information:

• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Rosiglitazone.
• If your blood sugar level is often higher than it should be and you are taking Rosiglitazone according to your health care provider�s directions, check with your health care provider.
• If you are taking insulin, during periods of stress such as fever, infection, or surgery, you may need to change your insulin dose. Talk with your health care provider.
• When using Rosiglitazone with insulin or other diabetes medicine, be sure that you and your family members know the risks, symptoms (eg, numbness, fatigue, hunger, sweating, rapid pulse, confusion), and treatment (eg, sugar-containing drinks or food) of low blood sugar.
• Management of type 2 diabetes should include diet control. Restriction of calories, weight loss, and exercise are essential for proper treatment. It is important to follow the diet guidelines given to you by your health care provider.
• If you are taking 2 antidiabetic medicines each day and you become irritable, lightheaded, or very tired, tell your doctor at once.
• Carry an identification card at all times that says you are diabetic.
• Monitor your blood sugar level regularly according to your doctor's directions. If you blood sugar level is often higher than it should be and you are taking Rosiglitazone according to the directions, check with your health care provider.
• Rosiglitazone may cause ovulation in women who have not reached menopause but do not ovulate. Be sure to use adequate birth control methods while using Rosiglitazone.
• LAB TESTS, including liver function and blood, will be required while you are using Rosiglitazone. Be sure to keep all doctor and lab appointments.
• Rosiglitazone should be used with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss the benefits and risks of using Rosiglitazone during pregnancy with your doctor. Do not breast-feed while taking Rosiglitazone.

Possible side effects of Rosiglitazone :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; diarrhea; headache; injury; sinus infection; upper respiratory tract infection.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abdominal pain; bloating or swelling of the ankles, feet, or hands; chest pain; confusion; dark urine; fast heartbeat; hunger; loss of appetite; nausea; numbness; pain; rapid weight gain; shortness of breath; stomach problems; sweating; tiredness; unusual thirst or amount of urine; vision changes; vomiting; yellowing of the skin.

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