INDICATIONS

Actos is used for treating type 2 diabetes in certain patients. It is used along with diet and exercise. It may be used alone or with other antidiabetic medicines. Actos is a thiazolidinedione antidiabetic. It works by lowering blood sugar by making the cells of the body more sensitive to the action of insulin.

INSTRUCTIONS

Use Actos as directed by your doctor.

• Take Actos by mouth with or without food.
• Continue to take Actos even if you feel well. Do not miss any dose.
• Taking Actos at the same time each day will help you remember to take it.
• If you miss a dose of Actos, take it as soon as possible. If it almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any question you may have about how to use Actos.

STORAGE

Store Actos at 77 degrees F (25 degrees C) in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Actos out of the reach of children and away from pets.

MORE INFO:

Active Ingredient: Pioglitazone hydrochloride.

All medicines may cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome:

Headache; muscle aches; sore throat; weight gain.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; symptoms of heart failure (eg, shortness of breath; sudden unexplained weight gain; swelling of the hands, ankles, or feet); symptoms of liver problems (eg, dark urine; stomach pain; unexplained nausea, vomiting, or loss of appetite; yellowing of the skin or eyes; sweating); symptoms of low blood sugar (eg, anxiety; chills, increased hunger, headache; increased dizziness or drowsiness; tremors); unusual bone pain; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.

Do NOT use Actos if:

• you are allergic to any ingredient in Actos
• you have moderate to severe heart failure
• you have type 1 diabetes
• you have a history of liver problems, including jaundice (yellowing of the skin or eyes), during therapy with a similar medicine called troglitazone.

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Actos. Tell your doctor or pharmacist if you have any medical condition, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have diabetic ketoacidosis (a severe problem associated with diabetes)
• if you have a history of liver problems, abnormal liver function tests, heart problems (eg, congestive heart failure [CHF]), or eye or vision problems
• if you have swelling problems (edema).

Some medicines may interact with Actos. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Gemfibrozil, insulin, or oral antidiabetic medicines (eg, glipizide) because the risk of low blood sugar may be increased
• Rifampin because it may decrease Actos's effectiveness, resulting in high blood sugar
• Anticoagulants (eg, warfarin) because the risk of their side effects may be increased or their effectiveness may be decreased by Actos.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Actos may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

• Proper diet, regular exercise, and regular blood sugar testing are important for best results with Actos. Follow the diet and exercise program given to you by your health care provider.
• Check your blood sugar levels as directed by your doctor. If they are often higher than they should be and you take Actos exactly as prescribed, tell your doctor.
• It may be harder to control your blood sugar during times of stress such as fever, infection, injury, or surgery. Talk with your doctor about how to control your blood sugar if any of these occur. Do not change the dose of your medicine without checking with your doctor.
• Do NOT take more than the recommended dose without checking with your doctor.
• Actos may cause low blood sugar levels when it is used along with insulin or other oral diabetic medicines. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
• Actos may cause ovulation in women who have not reached menopause but do not ovulate. Be sure to use effective birth control while using Actos.
• Tell your doctor or dentist that you take Actos before you receive any medical or dental care, emergency care, or surgery.
• Actos may be associated with an increased risk of bladder cancer. Discuss any questions or concerns with your doctor.
• An increased incidence of bone fracture has been reported in women who take Actos. Tell your doctor if you have a history of bone fracture, low calcium intake, or weak bones (eg, osteoporosis). Tell your doctor right away if you experience any unusual bone pain.
• Lab tests, including fasting blood sugar, hemoglobin A_1c, eye examinations, and liver function, may be performed while you use Actos. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Actos should not be used in children younger than 18 years old; safety and effectiveness in these children have not been confirmed.
• Pregnancy and breast-feeding: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Actos while you are pregnant. It is not known if Actos is found in breast milk. Do not feed breast while taking Actos.