Pioglitazone is used, along with diet and exercise, in the treatment of non-insulin-dependent diabetes mellitus (type II diabetes). Pioglitazone may also be used with a sulfonylurea (e.g., Diabeta, Glucotrol, Micronase, others), metformin (Glucophage), or insulin when diet and exercise plus any one of these medicines alone do not result in adequate blood sugar control.

Pioglitazone may also be used for purposes other than those listed in this medication guide.

Special precautions

* Do not take pioglitazone without first talking to your doctor if you have liver disease.

* Before taking this medication, tell your doctor if you

• have heart failure or heart disease;

• have edema (water retention or swelling);
• have type 1 diabetes mellitus (insulin-dependent diabetes);
• Have a serious infection, illness, or injury; or need surgery.

* You may not be able to take pioglitazone, or you may need a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

* Treatment with pioglitazone may cause resumption of fertility by allowing for the return of ovulation (production of eggs) in certain women with insulin resistance who were not ovulating before treatment with pioglitazone. Therefore, pregnancy may occur and birth control may be a consideration.

* Usually, liver function is monitored with blood tests at the start of treatment, every two months for the first year of treatment, and periodically thereafter during treatment with pioglitazone. Notify your doctor immediately if you develop nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, yellow skin or eyes, or dark urine. These symptoms may be early signs of liver problems.

* Notify your doctor immediately if you experience an unusually rapid increase in weight or edema (water retention), shortness of breath, or chest pain during treatment with pioglitazone. These may be early symptoms of heart problems.

* Pioglitazone usually does not cause hypoglycemia (low blood sugar). However, hypoglycemia may occur as a result of skipped meals, excessive exercise, or alcohol consumption while taking pioglitazone. Know the signs and symptoms of hypoglycemia, which include headache, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry hard candy or glucose tablets with you to treat episodes of low blood sugar.

* Pioglitazone may decrease the effects of some birth control pills. Additional measures may be necessary to prevent pregnancy while taking pioglitazone. Talk to your doctor about the use of birth control.

* Pioglitazone is in the FDA pregnancy category C. This means that it is not known whether pioglitazone will be harmful to an unborn baby. Generally, insulin is the drug of choice for controlling diabetes during pregnancy. Do not take pioglitazone without first talking to your doctor if you are pregnant or could become pregnant during treatment.

* It is not known whether pioglitazone passes into breast milk. Do not take pioglitazone without first talking to your doctor if you are breast-feeding a baby.

* The safety and effectiveness of pioglitazone have not been established for children.

* Avoid alcohol. It lowers blood sugar and may interfere with diabetes treatment.

* Tell your doctor and dentist that you are taking this medication before having surgery.

* Do not take over-the-counter or prescription cough, cold, allergy, pain, or weight-loss medications during treatment with pioglitazone without first talking to your doctor.

Side effects

If you experience any of the following serious side effects, stop taking pioglitazone and seek emergency medical attention or notify your doctor immediately:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

• nausea, vomiting, abdominal pain, or loss of appetite;
• unusual fatigue;
• yellowing of the skin or eyes; or
• Dark urine.

Notify your doctor immediately if you experience an unusually rapid increase in weight or edema (swelling, water retention), shortness of breath, or chest pain during treatment with pioglitazone. These may be early symptoms of heart problems.

Other less serious side effects may also occur. Continue to take pioglitazone and talk to your doctor if you experience:

• headache;

• muscle aches; or
• Sore throat, nasal discharge, or cold symptoms.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Keep all appointments with your doctor.

Do not let anyone else take your medicines.

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