SIDE EFFECTS: See also Warning section. Nausea, vomiting, stomach upset, diarrhea, weakness, sore throat, muscle pain, weight gain, tooth problems or a metallic taste in the mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If stomach symptoms return later (after taking the same dose for several days or weeks), tell your doctor right away. Stomach symptoms that occur after the first days of your treatment may be signs of lactic acidosis. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: new/worsening vision problems (such as blurred vision), bone fracture, reddish-colored urine, urgent need to urinate, pain while urinating. Pioglitazone may rarely cause liver disease. Tell your doctor right away if you develop symptoms of liver disease, including: dark urine, yellowing of eyes/skin, persistent nausea/vomiting, stomach/abdominal pain. This medication usually does not cause low blood sugar (hypoglycemia). Low blood sugar may occur if this drug is prescribed with other diabetes medications (such as insulin or a sulfonylurea). Low blood sugar is more likely if you drink large amounts of alcohol, do unusually heavy exercise, or do not consume enough calories from food. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your doctor right away. Your dosage may need to be increased. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking pioglitazone/metformin and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually once or twice daily with meals to decrease stomach upset. Drink plenty of fluids while taking this medication unless otherwise directed by your doctor. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). To reduce your risk of side effects (such as upset stomach), your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Take this medication regularly in order to get the most benefit from it. Remember to use it at the same time(s) each day. If you are already taking another diabetes medication, follow your doctor's directions carefully for stopping/continuing the old drug and starting this medication. Check your blood sugar regularly as directed by your doctor. Keep track of the results, and share them with your doctor. Tell your doctor if your blood sugar measurements are too high or too low. Your dosage/treatment may need to be changed. It may take up to 2 to 3 months before the full benefit of this drug takes effect.

PRECAUTIONS: See also Warning section. Before taking this medication, tell your doctor or pharmacist if you are allergic to pioglitazone or metformin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe breathing problems (such as obstructive lung disease, severe asthma), blood problems (such as anemia, vitamin B12 deficiency), kidney disease, liver disease, heart disease (such as congestive heart failure, chest pain), fluid in your lungs, swelling (edema), a certain eye problem (macular edema), bladder cancer. Before having surgery or any X-ray/scanning procedure using iodinated contrast, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). You may need to stop this medication for a short time for the surgery/procedure. Ask your doctor or dentist for instructions before your surgery/procedure. You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcohol while using this medication because it can increase your risk of lactic acidosis and developing low blood sugar. High fever, "water pills" (diuretics such as hydrochlorothiazide), too much sweating, diarrhea, or vomiting may cause dehydration and increase your risk of lactic acidosis. Stop taking this medication and tell your doctor right away if you have prolonged diarrhea or vomiting. Be sure to drink enough fluids to prevent dehydration unless your doctor directs you otherwise. It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because increased stress may require a change in your treatment plan, medications, or blood sugar testing. Pioglitazone may increase the risk of bone fracture in women (usually in the upper arm, hand, or foot). See also Notes section. Older adults may be at greater risk for side effects such as low blood sugar or lactic acidosis. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Your doctor may direct you to use insulin instead of this product during your pregnancy. Follow your doctor's instructions carefully. This medication can cause changes in the menstrual cycle (promote ovulation) and increase the risk of becoming pregnant. Consult your doctor or pharmacist about the use of reliable birth control while using this medication. Metformin passes into breast milk in small amounts. It is unknown if pioglitazone passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Other medications can affect the removal of pioglitazone from your body, which may affect how pioglitazone works. Examples include gemfibrozil, rifamycins including rifampin, among others. Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are unaffected by these drugs. Many drugs can affect your blood sugar, making it harder to control. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Overdose can cause lactic acidosis. Symptoms of overdose may include: severe drowsiness, severe nausea/vomiting/diarrhea, rapid breathing, slow/irregular heartbeat.