Important Safety Information About duetact® (pioglitazone HCl and glimepiride)
Duetact contains 2 prescription antidiabetic medicines: pioglitazone HCl (ACTOS) and glimepiride, a sulfonylurea. Duetact is used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes who are already taking ACTOS and a sulfonylurea together, or taking a sulfonylurea alone and it is not controlling blood sugar.
Duetact is not for everyone. Certain patients with heart failure should not start taking duetact. Duetact can cause or worsen congestive heart failure. Talk to your doctor immediately if you experience rapid weight gain, fluid retention (swelling), or shortness of breath.
Do not take duetact if you have active liver disease. Your doctor should perform a blood test to check for liver problems before you start duetact and periodically thereafter. Talk to your doctor immediately if you experience nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or yellowing of the skin. Some people taking duetact may experience flu-like symptoms, mild-to-moderate swelling of legs and ankles, and anemia. Duetact may cause low blood sugar. Lightheadedness, dizziness, shakiness, or hunger may mean that your blood sugar is too low. Talk to your doctor if low blood sugar is a problem for you.
Duetact may increase your risk of becoming pregnant. If you are pregnant or thinking about becoming pregnant, talk to your doctor before taking duetact. If you are nursing, do not take duetact. Some people, particularly women, are at higher risk of having bone fractures while taking duetact. Patients with diabetes should have regular eye exams. If you experience vision problems, consult your doctor immediately. Very rarely, some patients have experienced visual changes while taking pioglitazone, a component of duetact. Duetact should not be used in patients with type 1 diabetes.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch, or call 1-800-FDA-1088.