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FDA Approves ACTOplus met(R) XR (pioglitazone HCl and metformin HCl extended-release) Tablets for the Treatment of Type 2 Diabetes
Date:5/13/2009

pioglitazone, metformin, or any other component of ACTOplus met and ACTOplus met XR. ACTOplus met and ACTOplus met XR should not be taken by people who drink excessive amounts of alcohol. ACTOplus met and ACTOplus met XR should be discontinued in patients with severe infection or in patients undergoing X-ray studies using intravenous contrast dye. Talk to your health professional before discontinuing any medications.

Your health professional should perform a blood test to check for liver problems before you start ACTOplus met and ACTOplus met XR and periodically thereafter. Do not take ACTOplus met and ACTOplus met XR if you have active liver disease. Talk to your doctor immediately if you experience nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or yellowing of the skin. If you are of childbearing age, talk to your doctor before taking ACTOplus met and ACTOplus met XR, as they could increase your chance of becoming pregnant. Some people, particularly women, are at higher risk of having bone fractures while taking ACTOplus met and ACTOplus met XR. 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 ACTOplus met and ACTOplus met XR.

Safety and effectiveness of ACTOplus met and ACTOplus met XR in pediatric patients have not been established. Use in pediatric patients is not recommended for the treatment of diabetes due to lack of long-term safety data. ACTOplus met XR must be swallowed whole and not chewed, cut, or crushed.

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SOURCE Takeda Pharmaceutical Company Limited
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