Actoplus Met XR
Generic Name: Metformin Extended-Release/Pioglitazone Tablets (met-FOR-min/PYE-oh-GLI-ta-zone)
Brand Name: Actoplus Met XR
Actoplus Met XR 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 Actoplus Met XR .
Do not begin to take Actoplus Met XR if you are more 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 Actoplus Met XR 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 lightheadedness, 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 Actoplus Met XR may cause or worsen heart failure in some patients. Tell your doctor if you have a history of heart failure. Actoplus Met XR 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 Actoplus Met XR 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.
Actoplus Met XR is used for:
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Treating type 2 diabetes. It is used along with diet and exercise. It may be used alone or with other antidiabetic medicines.
Actoplus Met XR 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 Actoplus Met XR if:
- you are allergic to any ingredient in Actoplus Met XR
- you have type 1 diabetes
- you have 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 more 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.
Before using Actoplus Met XR :
Some medical conditions may interact with Actoplus Met XR . 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 Actoplus Met XR . 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 Actoplus Met XR 's side effects
- Rifampin because it may decrease Actoplus Met XR '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 Actoplus Met XR
This may not be a complete list of all interactions that may occur. Ask your health care provider if Actoplus Met XR 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 Actoplus Met XR :
Use Actoplus Met XR as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Actoplus Met XR comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Actoplus Met XR refilled.
- Take Actoplus Met XR by mouth with the evening meal, unless your doctor tells you otherwise.
- Swallow Actoplus Met XR whole. Do not break, crush, or chew before swallowing.
- Take Actoplus Met XR on a regular schedule to get the most benefit from it. Taking Actoplus Met XR at the same times each day will help you remember to take it.
- Continue to take Actoplus Met XR even if you feel well. Do not miss any doses.
- If you miss a dose of Actoplus Met XR , 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 Actoplus Met XR .
Important safety information:
- Actoplus Met XR may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Actoplus Met XR 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 Actoplus Met XR .
- Tell your doctor or dentist that you take Actoplus Met XR 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 Actoplus Met XR .
- Actoplus Met XR 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 Actoplus Met XR .
- 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 Actoplus Met XR exactly as prescribed, tell your doctor.
- Actoplus Met XR 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 Actoplus Met XR 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.
- Actoplus Met XR 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 Actoplus Met XR . 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.
- Actoplus Met XR may be associated with an increased risk of bladder cancer. Discuss any questions or concerns with your doctor.
- You may notice undissolved parts of Actoplus Met XR 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 Actoplus Met XR . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Actoplus Met XR 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.
- Actoplus Met XR 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 Actoplus Met XR while you are pregnant. It is not known if Actoplus Met XR is found in breast milk. Do not breast-feed while taking Actoplus Met XR .
Possible side effects of Actoplus Met XR :
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:
Seek medical attention right away if any of these SEVERE side effects occur:Cold-like symptoms; diarrhea; headache; indigestion; mild weight gain; nausea; stomach upset.
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 lightheadedness; 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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Symptoms may include dizziness or lightheadedness; 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 Actoplus Met XR :Store Actoplus Met XR at 77 degrees F (25 degrees C). 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 bathroom. Keep Actoplus Met XR out of the reach of children and away from pets.
General information:
- If you have any questions about Actoplus Met XR , please talk with your doctor, pharmacist, or other health care provider.
- Actoplus Met XR 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 Actoplus Met XR for an extended period of time, obtain refills before your supply runs out.
This information is a summary only. It does not contain all information about Actoplus Met XR . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
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ActoPlus Met XR Drug Interactions
