Pioglitazone (one ingredient in this combination medication) may rarely cause or worsen a certain heart problem (congestive heart failure). Tell your doctor right away if you notice any symptoms of heart failure, including: swelling of the hands/feet, unusual/sudden weight gain, trouble breathing, unusual tiredness.
This medication is not recommended for people with certain types of heart failure. Before using this medication, tell your doctor if you have heart failure.
Rarely, too much metformin (one ingredient in this combination medication) can build up in the body and cause a serious (sometimes fatal) condition called lactic acidosis. Lactic acidosis is more likely to happen in certain medical conditions such as kidney or liver disease, recent surgery, a serious infection, conditions that may cause a low level of oxygen in the blood or poor circulation (such as congestive heart failure, recent heart attack, recent stroke), heavy alcohol use, a severe loss of body fluids (dehydration), or X-ray or scanning procedures that require an injectable iodinated contrast drug. Tell your doctor right away if any of these conditions occur or if you notice a big change in your overall health. You may need to stop taking this medication temporarily. Older adults are also at higher risk, especially those older than 80 years who have not had kidney tests. (See also Side Effects and Precautions sections.)
Stop taking this medication and get medical help right away if you develop any of the following symptoms of lactic acidosis: unusual tiredness, dizziness, severe drowsiness, chills, blue/cold skin, muscle pain, fast/difficult breathing, slow/irregular heartbeat, stomach pain with nausea, vomiting, or diarrhea.Who should not take Actoplus Met XR?
This combination medication is used along with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.
Pioglitazone belongs to a class of drugs known as thiazolidinediones or "glitazones". Metformin and pioglitazone work by helping to restore your body's proper response to the insulin you naturally produce. Metformin also decreases the amount of sugar that your liver makes and that your stomach/intestines absorb.
Talk to your doctor about the risks and benefits of using pioglitazone-containing products.
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.
Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing. 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. To help you remember, take it at the same time each day.
If you are already taking another anti-diabetic drug, 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.
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.
An empty tablet shell may appear in your stool. This effect is harmless because your body has already absorbed the medication.
Remember that your doctor has prescribed this medication because he or she 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 anti-diabetic 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.
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 injectable iodinated contrast material, tell your doctor that you are taking this medication. You will need to temporarily stop this medication before the time of your surgery/procedure. Consult your doctor for further instructions.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. 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 loss of too much body water (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 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 level 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 levels, making it more difficult to control your blood sugar. 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 levels regularly as directed by your doctor. Tell your doctor about the results and of any symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your anti-diabetic medication, exercise program, or diet.
If overdose is suspected, contact a poison control center or emergency room 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.
Do not share this medication with others.
You should attend a diabetes education program to learn more about diabetes and all the important aspects of its treatment, including meals/diet, exercise, personal hygiene, medications, and getting regular eye/foot/medical exams.
Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, eating well-balanced meals containing adequate calcium and vitamin D, stopping smoking, and limiting alcohol. Consult your doctor to see if you need to take calcium/vitamin D supplements and discuss lifestyle changes that might benefit you.
Keep all medical appointments. Laboratory and/or medical tests (such as kidney/liver function tests, blood glucose, hemoglobin A1c, complete blood counts, eye exams) should be performed periodically to check for side effects and monitor your response to treatment. Check your blood sugar levels regularly as directed.
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised October 2015. Copyright(c) 2015 First Databank, Inc.
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