About ACTOplus met

Is ACTOplus met right for you?

Answer these questions and share them with your health professional to find out if ACTOplus met may be right for you:

  1. Are your premeal blood sugar levels consistently above 130 mg/dL?
  2. Are you having problems managing your diabetes with healthy eating and physical activity alone?
  3. Are you having problems managing your diabetes with your current oral medications or insulin injections?
  4. Are you already taking ACTOS and metformin together or metformin alone and your blood sugar is still not where it should be?
  5. Are you interested in a diabetes medication that may provide some improvements in HDL (good) cholesterol and triglyceride levels?

If you have type 2 diabetes and answered “yes” to any of these questions, ask your health professional if ACTOplus met is right for you. Remember, only your health professional can determine the best treatment for you.

Next: How ACTOplus met works

While ACTOplus met may provide some lipid benefits, ACTOplus met is not indicated to treat lipid disorders and should not be used as a substitute for lipid-lowering therapy.

The effects of these lipid changes on morbidity and mortality have not been determined.

Management of type 2 diabetes should also include nutritional counseling, weight reduction as needed, and exercise.

Please see Important Safety Information, including warnings about heart failure and lactic acidosis, below.

Important Safety Information About ACTOplus met® (pioglitazone HCl and metformin HCl)

ACTOplus met contains two prescription antidiabetic medicines: pioglitazone HCl (ACTOS) and metformin HCl. ACTOplus met is used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes who are already taking ACTOS and metformin together, or taking metformin alone and it is not controlling blood sugar at normal levels.

ACTOplus met is not for everyone. Certain patients with heart failure should not start taking ACTOplus met. ACTOplus met 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.

A small number of people who have taken metformin, a component of ACTOplus met, have developed a rare, serious condition called lactic acidosis. Lactic acidosis, a buildup of lactic acid in the blood, can be fatal in about half the cases. Because lactic acidosis occurs most frequently in people with kidney problems, ACTOplus met should not be used in people with kidney disease or in people 80 years of age and older whose kidneys do not work properly. ACTOplus met should not be taken by people with metabolic acidosis, or with hypersensitivity to pioglitazone, metformin, or any other component of ACTOplus met. ACTOplus met should not be taken by people who drink excessive amounts of alcohol. ACTOplus met 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 periodically thereafter. Do not take ACTOplus met 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, as it could increase your chance of becoming pregnant. Some people, particularly women, are at higher risk of having bone fractures while taking ACTOplus met. 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.

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.
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