When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to pioglitazone or if you have severe heart failure.

How to Use This Medicine:
Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

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

• Some medicines and foods can affect how pioglitazone works. Tell your doctor if you are taking any of the following:
  
  • Insulin or other medicine to treat diabetes
  • Gemfibrozil
  • Rifampin

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, heart disease, heart failure, or bladder cancer.
• This medicine may cause the following problems:
  
  • Low blood sugar
  • Liver damage
  • Congestive heart failure
  • Broken bones, especially in women
  • Bladder cancer, if taken for more than 12 months
  • Macular edema (swelling behind the eye)
• Women: This medicine can cause you to ovulate if you did not ovulate regularly before. This means you could get pregnant. Talk with your doctor about birth control if this is a concern for you.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Blood in your urine, pain when urinating, urgent need to urinate, change in how often or how much you urinate
• Blurred vision, trouble seeing, vision changes
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Lightheadedness, dizziness, shakiness, or increased hunger
• Rapid weight gain, swelling in your hands, ankles, or feet, trouble breathing
• Unusual tiredness or weakness

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

• Cough, runny or stuffy nose, sneezing, or sore throat

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