"The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called keto"...
Avandamet Consumer (continued)
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 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.
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.
Read the Avandamet (rosiglitazone maleate and metformin hcl) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: 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.
Additional Avandamet Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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