Pioglitazone is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Pioglitazone is not for treating type 1 diabetes.

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

Pioglitazone can cause or worsen congestive heart failure. You should not use this medicine if you have severe or uncontrolled heart failure.

Stop using this medicine and call your doctor at once if you have shortness of breath (especially when lying down), unusual tiredness, swelling, or rapid weight gain.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Pioglitazone is usually taken once daily, with or without food.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Pioglitazone is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Usual Adult Dose for Diabetes Type 2:

-Patients without congestive heart failure:
Initial dose: 15 mg or 30 mg orally once a day
-Patients with congestive heart failure (New York Heart Association [NYHA] Class I or II):
Initial dose: 15 mg orally once a day

Maintenance dose: 15 mg to 45 mg orally once a day based on glycemic response as determined by HbA1c
Maximum dose: 45 mg orally once a day

Comments:
-This drug exerts its antihyperglycemic effect only in the presence of endogenous insulin and therefore is not expected to be effective in patients with type 1 diabetes mellitus or diabetic ketoacidosis.
-Patients concomitantly receiving an insulin secretagogue or insulin may need to reduce the dose of the insulin secretagogue or insulin if hypoglycemia occurs.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings

You should not use pioglitazone if you are allergic to pioglitazone, or if you have:

• severe or uncontrolled heart failure; or

• diabetic ketoacidosis (call your doctor for treatment).

This medication may increase your risk of developing bladder cancer. Talk with your doctor about your specific risk.

Tell your doctor if you have ever had:

• congestive heart failure or heart disease;

• a heart attack or stroke;

• eye problems caused by diabetes;

• bladder cancer; or

• liver disease.

Pioglitazone may increase your risk of serious heart problems, but not treating your diabetes can also damage your heart and other organs. Talk to your doctor about the risks and benefits of this medicine.

Follow your doctor's instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

Pioglitazone may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

Women may be more likely to have a broken bone while using pioglitazone. Talk with your doctor about ways to keep your bones healthy.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Pioglitazone is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have signs of low blood sugar, such as extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

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).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

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.

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

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using pioglitazone and call your doctor at once if you have symptoms of liver damage: nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Pioglitazone may cause serious side effects. Call your doctor at once if you have:

• shortness of breath (especially when lying down), unusual tiredness, swelling, rapid weight gain;

• pink or red urine, painful or difficult urination, new or worsening urge to urinate;

• changes in your vision; or

• sudden unusual pain in your hand, arm, or foot.

Some people taking pioglitazone have had bladder cancer, but it is not clear if pioglitazone was the actual cause.

Common side effects of pioglitazone may include:

• headache;

• muscle pain; or

• cold symptoms such as stuffy nose, sinus pain, sneezing, sore throat.

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.

Tell your doctor if you use insulin. Taking pioglitazone while you are using insulin may increase your risk of serious heart problems.

Many drugs can affect pioglitazone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor, your eye doctor, and the laboratory. Your doctor will probably order regular eye examinations and certain laboratory tests before and during your treatment 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.

• Actoplus Met® (containing Metformin, Pioglitazone)
• Actoplus Met® XR (containing Metformin, Pioglitazone)
• Duetact® (containing Glimepiride, Pioglitazone)