Avandamet

This combination medication is used along with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes (non-insulin-dependent diabetes). This medication works by helping to restore your body's proper response to the insulin you naturally produce. Rosiglitazone-containing medications should only be used when other medications cannot be taken or have not worked well. Talk to your doctor about the risks and benefits of this product (see Warning section). 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. Rosiglitazone belongs to a class of drugs known as thiazolidinediones or "glitazones." Metformin is a biguanide-type drug.

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.

Read the Medication Guide provided by your pharmacist before you start taking this medication and each time you get a refill. Read and sign the Informed Consent form provided by your doctor. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth, usually once or twice daily with a meal or as directed by your doctor. The dosage is based on your medical condition and response to therapy. Taking more than 8 milligrams of rosiglitazone per day, or more than 2000 milligrams of metformin per day, is not recommended unless your doctor directs otherwise. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: birth control pills, bupropion, calcium channel blockers (e.g., nifedipine), cephalexin, cimetidine, corticosteroids (e.g., prednisone), decongestants, other diabetes drugs (e.g., glyburide, acarbose, insulin), estrogens, gemfibrozil, herbal products (e.g., fenugreek, Gymnema, ginseng), isoniazid, niacin, phenothiazines (e.g., chlorpromazine), phenytoin, nitrates (e.g., isosorbide dinitrate), quinolone antibiotics (e.g., ciprofloxacin), rifampin, thyroid drugs, "water pills" (diuretics such as hydrochlorothiazide, furosemide). Beta-blocker medications (e.g., 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. If you are scheduled to undergo any X-ray or scanning procedure using injectable iodinated contrast material, be sure to inform your doctor that you are taking this medication. You will need to temporarily stop this medication around the time of your procedure. Consult your doctor for further instructions. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).

Do not share this medication with others. It is recommended you attend a diabetes education program to understand diabetes and all the important aspects of its treatment, including meals/diet, exercise, personal hygiene, medications, and getting regular eye, foot and 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 (e.g., liver and kidney function tests, fasting blood glucose, hemoglobin A1c, blood cholesterol levels, complete blood counts) will be performed from time to time to monitor for side effects and response to therapy. Regularly check your blood or urine for sugar as directed by your doctor or pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: rapid/difficult breathing, severe drowsiness, slow/irregular heartbeat.

Before taking rosiglitazone/metformin, tell your doctor or pharmacist if you are allergic to it; or to other "glitazones" such as pioglitazone; 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. Promptly talk with your doctor or pharmacist about the benefits and possible risks of this medication, even if you have been taking it for awhile, especially if you have heart problems. Do not stop taking it unless directed to do so. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease, history of liver disease, conditions that may cause a low oxygen blood level or poor circulation (e.g., severe congestive heart failure, recent heart attack, recent stroke), lack of body fluids (dehydration), serious infection, metabolic acidosis (e.g., diabetic ketoacidosis), type 1 diabetes (insulin-dependent diabetes). Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe breathing problems (e.g., obstructive lung disease, severe asthma), heart disease (e.g., chronic congestive heart failure, heart attack, angina), blood problems (e.g., anemia, vitamin B-12 deficiency), swelling (edema), fertility problems (e.g., ovulation problems), high cholesterol, upcoming surgery, alcohol use, eye (retina) problems, bone problems (e.g., osteoporosis, osteopenia). 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 taking this medication because it can increase the risk of developing low blood sugar. During times of stress, such as fever, infection, injury or surgery, it may be more difficult to control your blood sugar. Consult your doctor, as a change in your medication or how often you test your blood sugar may be required. This medication may increase the risk of bone fracture (upper arm, hand, foot) in female patients. To lower the chance of getting injured, use caution when doing activities such as contact sports. Kidney function declines as you grow older. The metformin in this product is removed by the kidneys. Therefore, elderly people may be at a greater risk for low blood sugar and lactic acidosis while using this drug. Children may be more sensitive to the effects of this drug, especially low blood sugar. This medication can cause changes in the menstrual cycle (promote ovulation) in women with certain fertility problems, increasing the risk of becoming pregnant. Consult your doctor or pharmacist about the use of reliable birth control while using this medication. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Your doctor may substitute insulin for this drug during your pregnancy. Follow all instructions carefully. This medication passes into breast milk. Consult your doctor before breast-feeding.

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage from 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product.

See also Warning section. Nausea, stomach upset, diarrhea and metallic taste may occur at the beginning of treatment as your body adjusts to the medication. If stomach symptoms return later (after you are on the same dose for several days or more), tell your doctor immediately. Returning stomach symptoms may be due to lactic acidosis. Headache, joint pain, weight gain, loss of appetite, cough and fever may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. 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 immediately if this unlikely but serious side effect occurs: bone fracture. Seek immediate medical attention if any of these rare but very serious side effects occur: vomiting, stomach pain, yellowing eyes/skin, dark urine, vision changes (e.g., color or night vision problems). This medication usually does not cause low blood sugar (hypoglycemia), but this effect may occur if you do not consume enough calories (from food, juices, fruit, etc.). The symptoms include chills, cold sweat, dizziness, drowsiness, shaking, rapid heart rate, weakness, headache, fainting, tingling of the hands/feet, or hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you are in a situation where you don't have these reliable forms of glucose, eat a quick source of sugar such as table sugar, honey, or candy, or drink a glass of orange juice or non-diet soda to quickly raise your blood sugar level. Tell your doctor immediately about the reaction. To help prevent hypoglycemia, eat meals on a regular schedule and do not skip meals. Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your medication dosage may need to be increased. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe 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. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

The rosiglitazone in this medication may infrequently cause or worsen certain heart problems (congestive heart failure, heart attack). Seek immediate medical attention if you notice any symptoms of heart problems, including: swelling of the hands/feet, unusual/sudden weight gain, trouble breathing, chest pain/discomfort. The metformin in this combination medication can rarely cause a condition called lactic acidosis, which can be fatal. Seek immediate medical attention if you develop any of the following symptoms of lactic acidosis: unusual tiredness, severe drowsiness, cold skin, muscle pain, rapid/difficult breathing, unusually slow/irregular heartbeat. Lactic acidosis is more likely to occur in patients who have: serious infection, surgery, kidney or liver disease, conditions that may cause a low level of oxygen in the blood or poor circulation (e.g., severe congestive heart failure, recent heart attack or stroke), excessive alcohol use, a lack of body fluids (dehydration), X-ray or scanning procedures that require an injectable iodinated contrast drug. The elderly are also at a higher risk, especially people over 80 who have not had kidney and liver tests.