The rosiglitazone in this medication may infrequently 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.
This medication is not recommended in patients with certain types of heart failure. Before using this medication, tell your doctor if you have heart failure.
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.Who should not take rosiglitazone-metformin?
This combination medication is used along with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. This medication works by helping to restore your body's proper response to the insulin you naturally produce.
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.
Read the Medication Guide provided by your pharmacist before you start taking this medication and each time you get a refill. 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.
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.
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.
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: bone fracture, persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine, vision changes (e.g., color or night vision problems).
Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, unusual sweating.
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 rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
In the US -
See also Warning section.
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.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, breathing problems (e.g., obstructive lung disease, severe asthma), heart disease (e.g., 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, 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.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
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.
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.
A product that may interact with this drug is: insulin.
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.
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 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.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: rapid/difficult breathing, severe drowsiness, slow/irregular heartbeat.
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 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 May 2014. Copyright(c) 2014 First Databank, Inc.
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