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Brand Names: Actos

Generic Name: pioglitazone (oral) (Pronunciation: PYE o GLIT a zone)

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

What is pioglitazone (Actos)?

Pioglitazone is an oral diabetes medicine that helps control blood sugar levels.

Pioglitazone is for people with type 2 (non-insulin-dependent) diabetes. Pioglitazone is sometimes used in combination with insulin or other medications, but it is not for treating type 1 diabetes.

Pioglitazone may also be used for purposes not listed in this medication guide.

Actos 15 mg

round, white, imprinted with ACTOS, 15

Actos 30 mg

round, white, imprinted with ACTOS, 30

Actos 45 mg

round, white, imprinted with ACTOS, 45

What are the possible side effects of pioglitazone (Actos)?

Stop using pioglitazone and call your doctor at once if you have any of these serious side effects:

• stomach pain, blood in your urine;
• painful urination;
• feeling short of breath, even with mild exertion;
• swelling or rapid weight gain;
• chest pain, general ill feeling;
• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• blurred vision;
• increased thirst or hunger, urinating more than usual; or
• pale skin, easy bruising or bleeding, weakness.

Less serious side effects may include:

• cold symptoms such as stuffy nose, sneezing, cough, sore throat;
• headache;
• gradual weight gain;
• muscle pain;
• back pain; or
• tooth problems.

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 pioglitazone (Actos)?

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

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

Before taking pioglitazone, tell your doctor if you have congestive heart failure or heart disease, fluid retention, a history of bladder cancer, a history of heart attack or stroke, or liver disease.

Take care not to let your blood sugar get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.

Some women using pioglitazone have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control.

Women may also be more likely than men to have bone fractures in the upper arm, hand, or foot while taking pioglitazone. Talk with your doctor if you are concerned about this possibility.

Certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with pioglitazone.

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