Actos contains the active ingredient pioglitazone in the form of pioglitazone hydrochloride, which is a thiazolidinedione and acts as an agonist for the peroxisome proliferator-activated receptor (PPAR) gamma. This medication is formulated as a tablet for oral administration with dosage strengths of 15 mg, 30 mg, or 45 mg. Key inactive ingredients include carboxymethylcellulose calcium, hydroxypropyl cellulose, lactose monohydrate, and magnesium stearate.

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. Take your medication at the same time each day. Do not take more often than directed. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed and protect from moisture and humidity. Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Change in vision such as blurry vision, seeing halos around lights, vision loss -Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue -Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue -Red or dark brown urine, pain or trouble when passing urine, passing frequent amounts of urine Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Headache -Muscle pain -Runny or stuffy nose

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Bladder cancer -Diabetic ketoacidosis -Eye disease called macular edema -Heart disease -Heart failure -Kidney disease -Liver disease -Polycystic ovary syndrome -Premenopausal -Swelling of the arms, legs, or feet -Type 1 diabetes -An unusual or allergic reaction to pioglitazone, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

-Gemfibrozil -Rifampin -Topiramate Other medications may affect the way this medication works. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended. Some medications may affect your blood sugar levels or hide the symptoms of low blood sugar (hypoglycemia). Talk with your care team about all the medications you take. They may suggest changes to your dose or checking your blood sugar levels more often. Medications that may affect your blood sugar levels include: -Alcohol -Certain antibiotics, such as ciprofloxacin, levofloxacin, sulfamethoxazole; trimethoprim -Certain medications for blood pressure or heart disease, such as benazepril, enalapril, lisinopril, losartan, valsartan -Certain medications for mental health conditions, such as fluoxetine or olanzapine -Diuretics, such as hydrochlorothiazide (HCTZ) -Estrogen and progestin hormones -Other medications for diabetes -Steroid medications, such as prednisone or cortisone -Testosterone -Thyroid hormones Medications that may mask symptoms of low blood sugar include: -Beta blockers, such as atenolol, metoprolol, propranolol -Clonidine -Guanethidine -Reserpine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. You may need blood work done while you are taking this medication. Your care team will monitor your HbA1C (A1C). This test shows what your average blood sugar (glucose) level was over the past 2 to 3 months. Know the symptoms of low blood sugar and know how to treat it. Always carry a source of quick sugar with you. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink if your blood sugar is too low and you are unable to care for yourself. Get medical help at once. Tell your care team if you have high blood sugar. Your medication dose may change if your body is under stress. Some types of stress that may affect your blood sugar include fever, infection, and surgery. Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the medications and doses you take on the card. This medication may cause you to ovulate, which may increase your chances of becoming pregnant. Talk with your care team about contraception while you are taking this medication. Contact your care team if you think you might be pregnant.

What are the most serious risks of this medication?

This medicine may cause new or worse heart failure. Do not take this medicine if you have severe heart failure. Talk to your healthcare provider about taking this medicine if you have symptoms of heart failure like shortness of breath or swelling.