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Brand Names: Actoplus Met, Actoplus Met XR

Generic Name: metformin and pioglitazone (Pronunciation: met FOR min and PYE o GLI ta zone)

• What is metformin and pioglitazone (Actoplus Met, Actoplus Met XR)?
• What are the possible side effects of metformin and pioglitazone (Actoplus Met, Actoplus Met XR)?
• What is the most important information I should know about metformin and pioglitazone (Actoplus Met, Actoplus Met XR)?
• What should I discuss with my healthcare provider before taking metformin and pioglitazone (Actoplus Met, Actoplus Met XR)?
• How should I take metformin and pioglitazone (Actoplus Met, Actoplus Met XR)?
• What happens if I miss a dose (Actoplus Met, Actoplus Met XR)?
• What happens if I overdose (Actoplus Met, Actoplus Met XR)?
• What should I avoid while taking metformin and pioglitazone (Actoplus Met, Actoplus Met XR)?
• What other drugs will affect metformin and pioglitazone (Actoplus Met, Actoplus Met XR)?
• Where can I get more information?

What is metformin and pioglitazone (Actoplus Met, Actoplus Met XR)?

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

Metformin and pioglitazone is for people with type 2 diabetes who do not use daily insulin injections. This medication is not for treating type 1 diabetes.

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

Actoplus Met 15-500 mg

oblong, white, imprinted with 4833M, 15/500

Actoplus Met 15-850 mg

oblong, white, imprinted with 4833M, 15/850

What are the possible side effects of metformin and pioglitazone (Actoplus Met, Actoplus Met XR)?

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or irregular heart rate, dizziness, or feeling very weak or tired.

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

Call your doctor at once if you have any other serious side effects, such as:

• stomach pain, blood in your urine, painful urination;
• feeling short of breath, especially when lying down;
• swelling or rapid weight gain;
• pale skin, feeling light-headed, rapid heart rate, trouble concentrating;
• sudden unusual pain in your hand, arm, or foot; or
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• headache;
• diarrhea, upset stomach; or
• sneezing, runny nose, cough or other signs of a cold.

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.

What is the most important information I should know about metformin and pioglitazone (Actoplus Met, Actoplus Met XR)?

You should not use this medication if you are allergic to metformin (Glucophage) or pioglitazone (Actos), or if you have kidney problems, severe heart failure, active bladder cancer, or metabolic acidosis. Do not use metformin and pioglitazone if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Do not take this medicine for longer than recommended. Taking pioglitazone for longer than 1 year (12 months) may increase your risk of developing bladder cancer. Talk with your doctor about your specific risk.

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking metformin and pioglitazone.

Before taking metformin and pioglitazone, tell your doctor if you have congestive heart failure or heart disease, a history of bladder cancer, a history of heart attack or stroke, liver disease, eye problems caused by diabetes, or if you are 80 years or older.

Some people develop lactic acidosis while taking metformin. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

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