Pioglitazone (By mouth)

Brand Name(s)

Actos

When This Medicine Should Not Be Used

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Introduction

Pioglitazone (pye-oh-GLI-ta-zone)

Used together with proper diet and exercise to help control blood sugar in adults with type 2 diabetes.

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food.
• Carefully follow your doctor's instructions about a special diet, exercise, or weight loss. Check your blood sugar on a regular basis at home.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using other medicines to treat your diabetes, such as insulin. Tell your doctor if you are using gemfibrozil (Lopid®) or rifampin (Rifadin®, Rimactane®).

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding. Certain women may be at an increased risk for pregnancy while taking this medicine. If you had problems ovulating and had irregular periods in the past, this medicine may cause you to ovulate. This could increase your chance of becoming pregnant. Talk to your doctor about effective birth control while you are using this medicine.
• Make sure your doctor knows if you have liver disease, heart disease, congestive heart failure, or edema (problems with fluid retention or swelling). Also, tell your doctor if you have an eye disease such as macular edema (swelling of the back of the eye), fragile bones (especially women), or a history of bladder cancer. Tell your doctor if you recently had a fever, infection, trauma, or surgery.
• This medicine may not work as well if you have surgery, get hurt, or get sick. If you have severe vomiting, diarrhea, or fever, call your doctor for instructions.
• Check with your doctor right away if you start having chest pain; shortness of breath; excessive swelling of the hands, wrist, ankles, or feet; or if you are rapidly gaining weight. These may be symptoms of a serious heart problem.
• If you have abdominal or stomach pain; dark urine; a loss of appetite; nausea or vomiting; unusual tiredness or weakness; or yellow eyes or skin, check with your doctor right away. These may be symptoms of a serious liver problem.
• Check with your doctor immediately if blurred vision, decreased vision, or any other change in vision occurs while you are taking this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
• This medicine may increase the risk for bone fractures in women. Ask your doctor about ways to keep your bones strong to help prevent fractures.
• This medicine may increase your risk for bladder cancer if you take it for more than 12 months. Tell your doctor right away if you have blood in the urine; a frequent, strong, or increased urge to urinate; painful urination; or pain in the back, lower abdomen, or stomach.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments. You will also need to check your blood sugar on a regular basis at home.
• Some things that can lead to low blood sugar are exercising more than normal or waiting too long to eat. Tell your doctor about any sudden change in your medical condition.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision or other changes in vision.
• Chest pain or uneven heartbeat.
• Dark-colored urine or pale stools.
• Lightheadedness, dizziness, shakiness, or increased hunger.
• Nausea, vomiting, loss of appetite, or pain in your upper stomach.
• Pain or swelling in the arms or legs without an injury.
• Rapid weight gain.
• Shortness of breath, cold sweats, and bluish-colored skin.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding or bruising.
• Unusual tiredness or weakness.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Cough, runny or stuffy nose, sneezing, or sore throat.
• Headache.
• Muscle pain.
• Problems with your teeth.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088