Metformin and pioglitazone is a combination of two oral diabetes medicines that help control blood sugar levels.

Metformin and pioglitazone is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus who do not use daily insulin injections. Metformin and pioglitazone is not for treating type 1 diabetes.

Metformin and pioglitazone may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to metformin or pioglitazone, or if you have:

• severe heart failure;
• severe kidney disease;
• active bladder cancer; or
• metabolic acidosis or ketoacidosis (call your doctor for treatment).

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking metformin and pioglitazone. Be sure your caregivers know ahead of time that you are using this medicine.

Tell your doctor if you have ever had:

• kidney problems;
• congestive heart failure or other heart problems;
• fluid retention;
• eye problems caused by diabetes;
• bladder cancer;
• a heart attack or stroke;
• liver disease; or
• if you are 80 years or older.

This medication may increase your risk of developing bladder cancer. Talk with your doctor about your specific risk.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.

Metformin and pioglitazone may increase your risk of serious heart problems, but not treating your diabetes can also damage your heart and other organs. Talk to your doctor about the risks and benefits of this medicine.

Follow your doctor's instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

Metformin may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

Women may be more likely to have a broken bone while using metformin and pioglitazone. Talk with your doctor about ways to keep your bones healthy.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Metformin and pioglitazone is not approved for use by anyone younger than 18 years old.

Use Actoplus Met (Metformin Pioglitazone) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people using metformin and pioglitazone develop lactic acidosis, which can be fatal. Get emergency medical help if you have even mild symptoms such as:

• unusual muscle pain;
• feeling cold;
• trouble breathing;
• feeling dizzy, light-headed, tired, or very weak;
• stomach pain, vomiting; or
• slow or irregular heart rate.

Call your doctor at once if you have:

• pink or red urine, painful or difficult urination, new or worsening urge to urinate;
• changes in your vision;
• heart problems-- swelling, rapid weight gain, feeling short of breath;
• liver problems--loss of appetite, nausea, vomiting, stomach pain, tiredness, dark urine, jaundice (yellowing of the skin or eyes); or
• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects may include:

• headache;
• weight gain;
• diarrhea; or
• cold symptoms such as stuffy nose, sinus pain, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Avoid drinking alcohol. It can lower your blood sugar and may increase your risk of lactic acidosis.