Important Safety Information for Avandaryl®

Important Safety Information for Avandaryl®
GlaxoSmithKline

Avandaryl, along with diet and exercise, helps improve blood sugar control in patients with type 2 diabetes. Avandaryl is a combination of two drugs - rosiglitazone maleate and glimepiride.

Avandaryl can cause or worsen heart failure. If you have severe heart failure (very poor pumping ability of the heart), you cannot be started on Avandaryl. Avandaryl is also not recommended if you have heart failure with symptoms (such as shortness of breath or swelling) even if these symptoms are not severe.

Rosiglitazone, a component of Avandaryl, may increase your risk of other heart problems that occur when there is reduced blood flow to the heart, such as chest pain (angina) or heart attack (myocardial infarction). This risk appeared higher in patients taking medicines called nitrates or insulin. Taking rosiglitazone with insulin or with nitrates is not recommended.

If you have chest pain or a feeling of chest pressure, you should seek immediate medical attention, regardless of what diabetes medicines you are taking.

Avandaryl may cause low blood sugar. Lightheadedness, dizziness, shakiness or hunger may mean that your blood sugar is too low. If you have kidney problems, you may need a lower dose of Avandaryl to reduce problems with low blood sugar. Talk to your doctor if low blood sugar is a problem for you.

If you take Avandaryl, tell your doctor right away if you:
* Have swollen legs or ankles, a rapid increase in weight or difficulty breathing, or unusual tiredness
* Experience changes in vision
* Become pregnant

Review your medical history and tell your doctor if you:
* Have heart failure or other heart problems
* Have liver problems or liver disease
* Are pregnant or are nursing

Women taking Avandaryl should know that Avandaryl may increase the risk of pregnancy

More fractures have been observed in women taking Avandaryl .

For more information about Avandaryl, please see Patient Information. For further information on Avandaryl, please see full Prescribing Information.

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