Pioglitazone/ metformin extended-release tablets

Generic Name: pioglitazone/metformin (PYE-oh-GLI-ta-zone/met-FOR-min)
Brand Name: Actoplus Met XR

Pioglitazone/metformin extended-release tablets may rarely cause a serious and sometimes fatal condition called lactic acidosis. Most of these cases have occurred in diabetic patients who also have certain kidney problems. The risk of lactic acidosis may be greater if you have liver problems, kidney problems, or heart failure. The risk may also be greater in patients who are elderly or who drink alcohol. Lab tests, including kidney function, may be performed while you take pioglitazone/metformin extended-release tablets.

Do not begin to take pioglitazone/metformin extended-release tablets if you are older than 80 years old unless lab tests show that you do not have decreased kidney function. Do not take it if you have severe infection or low blood oxygen levels, or are dehydrated. Tell your doctor if you take pioglitazone/metformin extended-release tablets before you have any surgery or lab procedures.

Contact your doctor right away if you notice symptoms such as muscle pain or tenderness, unusual drowsiness, dizziness or light-headedness, slow or irregular heartbeat, fast or difficult breathing, unusual stomach discomfort, or unusual weakness or tiredness. Contact your doctor right away if you start to feel unusually cold, or if you have a general feeling of being unwell.

Thiazolidinedione antidiabetics such as pioglitazone/metformin extended-release tablets may cause or worsen heart failure in some patients. Tell your doctor if you have a history of heart failure. Pioglitazone/metformin extended-release tablets should not be used to treat patients with moderate to severe heart failure. You will be monitored for signs of heart failure when you start pioglitazone/metformin extended-release tablets and when your dose increases. Contact your doctor at once if you develop swelling of the hands, ankles, or feet; shortness of breath; or sudden, unexplained weight gain. Your doctor may need to stop your medicine or change your dose.


Pioglitazone/ metformin extended-release tablets is used for:

Treating type 2 diabetes. It is used along with diet and exercise. It may be used alone or with other antidiabetic medicines.

Pioglitazone/metformin extended-release tablets is a biguanide and thiazolidinedione antidiabetic combination. It works by decreasing the amount of sugar the liver produces and the intestines absorb. It also helps to make your body more sensitive to the insulin that you naturally produce.

Do NOT use pioglitazone/ metformin extended-release tablets if:

  • you are allergic to any ingredient in pioglitazone/metformin extended-release tablets
  • you have type 1 diabetes
  • you have bladder cancer or moderate to severe heart failure
  • you have a severe infection, low blood oxygen levels, kidney or liver problems, or high blood ketone or acid levels (eg, diabetic ketoacidosis), or you are severely dehydrated
  • you have had a stroke or a recent heart attack, or you are in shock
  • you are 80 years old or older and have not had a kidney function test
  • you will be having surgery or certain lab procedures
  • 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.

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Before using pioglitazone/ metformin extended-release tablets:

Some medical conditions may interact with pioglitazone/metformin extended-release tablets. Tell your doctor or pharmacist if you have any medical conditions, 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 a history of heart problems (eg, heart failure), abnormal liver function tests, lung or breathing problems, thyroid problems, stomach or bowel problems (eg, paralysis, blockage), adrenal or pituitary problems, eye or vision problems (eg, macular degeneration), bladder cancer, or lactic acidosis
  • if you have fluid retention or swelling problems, vomiting, diarrhea, poor health or nutrition, low blood calcium or vitamin B12 levels, or anemia, or if you are dehydrated
  • if you have an infection, fever, recent injury, or moderate to severe burns
  • if you have a history of bone fracture, weak bones (eg, osteoporosis), or low calcium intake
  • if you drink alcohol or have a history of alcohol abuse
  • if you will be having surgery or certain lab procedures
  • if you take a beta-blocker (eg, propranolol)

Some MEDICINES MAY INTERACT with pioglitazone/metformin extended-release tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Calcium channel blockers (eg, nifedipine), corticosteroids (eg, prednisone), diuretics (eg, furosemide, hydrochlorothiazide), estrogen, hormonal contraceptives (eg, birth control pills), insulin, isoniazid, nicotinic acid, oral antidiabetics (eg, glipizide), phenothiazines (eg, chlorpromazine), phenytoin, sympathomimetics (eg, albuterol, pseudoephedrine), or thyroid hormones (eg, levothyroxine) because the risk of high or low blood sugar may be increased
  • Amiloride, cimetidine, digoxin, gemfibrozil, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin because they may increase the risk of pioglitazone/metformin extended-release tablets's side effects
  • Rifampin because it may decrease pioglitazone/metformin extended-release tablets's effectiveness, resulting in high blood sugar
  • Anticoagulants (eg, warfarin) because their effectiveness may be decreased or the risk of their side effects may be increased by pioglitazone/metformin extended-release tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if pioglitazone/metformin extended-release tablets 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.

How to use pioglitazone/ metformin extended-release tablets:

Use pioglitazone/metformin extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Pioglitazone/metformin extended-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get pioglitazone/metformin extended-release tablets refilled.
  • Take pioglitazone/metformin extended-release tablets by mouth with the evening meal, unless your doctor tells you otherwise.
  • Swallow pioglitazone/metformin extended-release tablets whole. Do not break, crush, or chew before swallowing.
  • Take pioglitazone/metformin extended-release tablets on a regular schedule to get the most benefit from it. Taking pioglitazone/metformin extended-release tablets at the same times each day will help you remember to take it.
  • Continue to take pioglitazone/metformin extended-release tablets even if you feel well. Do not miss any doses.
  • If you miss a dose of pioglitazone/metformin extended-release tablets, 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 questions you may have about how to use pioglitazone/metformin extended-release tablets.

Important safety information:

  • Pioglitazone/metformin extended-release tablets may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use pioglitazone/metformin extended-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Follow the diet and exercise program given to you by your health care provider.
  • Talk to your doctor of health care provider before you drink alcohol while you use pioglitazone/metformin extended-release tablets.
  • Tell your doctor or dentist that you take pioglitazone/metformin extended-release tablets before you receive any medical or dental care, emergency care, or surgery.
  • Do NOT take more than the recommended dose without checking with your doctor.
  • Be careful not to become dehydrated, especially during hot weather, while you are being active, or if you have vomiting or diarrhea. Dehydration may increase your risk of side effects from pioglitazone/metformin extended-release tablets.
  • Pioglitazone/metformin extended-release tablets may cause ovulation in women who have not reached menopause but do not ovulate. Women who wish to avoid pregnancy should be sure to use effective birth control while using pioglitazone/metformin extended-release tablets.
  • Carry an ID card at all times that says you have diabetes. Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take pioglitazone/metformin extended-release tablets exactly as prescribed, tell your doctor.
  • Pioglitazone/metformin extended-release tablets does not usually cause low blood sugar. Low blood sugar may be more likely to occur if you skip a meal, exercise heavily, or drink alcohol. It may also be more likely if you take pioglitazone/metformin extended-release tablets along with certain other medicines for diabetes (eg, sulfonylureas, insulin). 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.
  • Fever, infection, injury, or surgery may increase your risk for high or low blood sugar levels. If any of these occur, check your blood sugar closely and tell your doctor right away.
  • Pioglitazone/metformin extended-release tablets may commonly cause stomach upset, indigestion, nausea, or diarrhea at the beginning of treatment. If you develop unusual or unexpected stomach problems, or if you develop stomach problems later during treatment, contact your doctor at once. This may be a sign of lactic acidosis.
  • An increased incidence of bone fracture has been reported in women who take pioglitazone/metformin extended-release tablets. 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.
  • Pioglitazone/metformin extended-release tablets may be associated with an increased risk of bladder cancer. Tell your doctor right away if you notice symptoms that could be associated with bladder cancer (eg, a red color or blood in the urine, difficult or painful urination, an increased need to urinate). Discuss any questions or concerns with your doctor.
  • You may notice undissolved parts of pioglitazone/metformin extended-release tablets in your stool. This is normal and not a cause for concern.
  • Lab tests, including kidney and liver function, fasting blood glucose, hemoglobin A1c, blood counts, and eye examinations, may be performed while you use pioglitazone/metformin extended-release tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use pioglitazone/metformin extended-release tablets with caution in the ELDERLY; they may be more sensitive to its effects. Low blood sugar levels may also be more difficult to recognize in the elderly.
  • Pioglitazone/metformin extended-release tablets should not be used in CHILDREN; safety and effectiveness in 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 pioglitazone/metformin extended-release tablets while you are pregnant. It is not known if pioglitazone/metformin extended-release tablets is found in breast milk. Do not breast-feed while taking pioglitazone/metformin extended-release tablets.

Possible side effects of pioglitazone/ metformin extended-release tablets:

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:

Cold-like symptoms; diarrhea; headache; indigestion; mild weight gain; nausea; stomach upset.

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; bone pain; chest pain or discomfort; dark urine; difficult or painful urination; dizziness or light-headedness; fainting; fast or difficult breathing; feeling of being unusually cold; general feeling of being unwell; muscle pain or weakness; pale stools; persistent loss of appetite; severe or persistent headache, nausea, or vomiting; shortness of breath; slow or irregular heartbeat; sudden, unexplained weight gain; swelling of the hands, ankles, or feet; unusual stomach pain or discomfort; unusual drowsiness; unusual tiredness or weakness; yellowing of the eyes or skin.

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. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dizziness or light-headedness; fast or difficult breathing; feeling of being unusually cold; general feeling of being unwell; muscle pain or tenderness; slow or irregular heartbeat; unusual drowsiness; unusual stomach discomfort; unusual weakness or tiredness.

Proper storage of pioglitazone/metformin extended-release tablets:

Store pioglitazone/metformin extended-release tablets between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in bathroom. Keep pioglitazone/metformin extended-release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about pioglitazone/metformin extended-release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Pioglitazone/metformin extended-release tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • If using pioglitazone/metformin extended-release tablets for an extended period of time, obtain refills before your supply runs out.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take pioglitazone/metformin extended-release tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about pioglitazone/metformin extended-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to pioglitazone/metformin extended-release tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using pioglitazone/metformin extended-release tablets.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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