Brand Name(s):

• Actos®
• Actoplus Met®(as a combination product containing Metformin, Pioglitazone)
• Actoplus Met®XR (as a combination product containing Metformin, Pioglitazone)
• Duetact®(as a combination product containing Glimepiride, Pioglitazone)

IMPORTANT WARNING

Pioglitazone and other similar medications for diabetes may cause or worsen congestive heart failure (condition in which the heart is unable to pump enough blood to the other parts of the body). Before you start to take pioglitazone, tell your doctor if you have or have ever had congestive heart failure, especially if your heart failure is so severe that you must limit your activity and are only comfortable when you are at rest or you must remain in a chair or bed. Also tell your doctor if you were born with a heart defect, and if you have or have ever had swelling of the arms, hands, feet, ankles, or lower legs; heart disease; high cholesterol or fats in the blood; high blood pressure; coronary artery disease (narrowing of the blood vessels that supply blood to the heart); a heart attack; an irregular heartbeat; or sleep apnea. Your doctor may tell you not to take pioglitazone or may monitor you carefully during your treatment.

If you develop congestive heart failure, you may experience certain symptoms. Tell your doctor immediately if you have any of the following symptoms, especially when you first start taking pioglitazone or after your dose is increased: large weight gain in a short period of time; shortness of breath; swelling of the arms, hands, feet, ankles, or lower legs; swelling or pain in the stomach; waking up short of breath during the night; needing to sleep with extra pillows under your head in order to breathe easier while lying down; frequent dry cough or wheezing; difficulty thinking clearly or confusion; fast or racing heart beat; not able to walk or exercise as well; or increased tiredness.

WHY is this medicine prescribed?

Pioglitazone is used with a diet and exercise program and sometimes with other medications, to treat type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood). Pioglitazone is in a class of medications called thiazolidinediones. It works by increasing the body's sensitivity to insulin, a natural substance that helps control blood sugar levels. Pioglitazone is not used to treat type 1 diabetes (condition in which the body does not produce insulin and, therefore, cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated).

HOW should this medicine be used?

Pioglitazone comes as a tablet to take by mouth. It is usually taken once daily with or without meals. Take pioglitazone at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take pioglitazone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of pioglitazone and gradually increase your dose.

Pioglitazone controls type 2 diabetes but does not cure it. It may take 2 weeks for your blood sugar to decrease and 2 to 3 months for you to feel the full effect of pioglitazone. Continue to take pioglitazone even if you feel well. Do not stop taking pioglitazone without talking to your doctor.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking pioglitazone,

• tell your doctor and pharmacist if you are allergic to pioglitazone, any other medications, or any of the ingredients in pioglitazone tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Be sure to mention any of the following: atorvastatin (Lipitor), gemfibrozil (Lopid), hormonal contraceptives (birth control pills, patches, rings, implants, and injections), insulin or other medications to treat diabetes; ketoconazole (Nizoral), midazolam (Versed), nifedipine (Procardia), and rifampin (Rifadin, Rifater, in Rifamate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section, or if you have or have ever had bladder cancer, diabetic eye disease, or kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking pioglitazone, call your doctor. Do not breast-feed while you are taking pioglitazone.
• if you have not yet experienced menopause (change of life; end of monthly periods) you should know that pioglitazone may increase the chance that you will become pregnant even if you do not have regular monthly periods or if you have a condition that prevents you from ovulating (releasing an egg from the ovaries). Talk to your doctor about methods of birth control that will work for you.
• if you will be having surgery, including dental surgery, tell the doctor or dentist that you are taking pioglitazone.
• ask your doctor what to do if you get sick, develop an infection or fever, experience unusual stress, or are injured. These conditions can affect your blood sugar and the amount of pioglitazone you may need.

What SPECIAL DIETARY instructions should I follow?

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthy diet, exercise regularly, and lose weight if necessary. This will help to control your diabetes and help pioglitazone work more effectively.

Alcohol may cause a decrease in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are taking pioglitazone.

What should I do IF I FORGET to take a dose?

If you remember that same day, take the missed dose as soon as your remember it. However, if you do not remember until the next day, skip the missed dose and continue your regular dosing schedule. Do not take more than one dose in one day and do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat, light, and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor, your eye doctor, and the laboratory. Your doctor will probably order regular eye examinations and certain laboratory tests to check your body's response to pioglitazone. Your blood sugar and glycosolated hemoglobin should be checked regularly to determine your response to pioglitazone. Your doctor will also tell you how to check your response to pioglitazone by measuring your blood or urine sugar levels at home. Follow these directions carefully.

You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: October 15, 2011.