Type of medicine: antihyperglycemic; antidiabetic
Generic and brand names: rosiglitazone maleate and metformin hydrochloride, oral; Avandamet
This medicine is taken by mouth to treat type 2 diabetes when diet and exercise have not controlled blood sugar levels.
Because this medicine has been associated with serious side effects, it is restricted to people who:
Talk with your healthcare provider about this.
You must be enrolled in a special program before you can receive this medicine. Only a few healthcare providers are allowed to prescribe this medicine. Also, only a few pharmacies are allowed to sell it. For more information call 1-800-AVANDIA.
Tell your healthcare provider if you have ever had:
Also tell your provider if you:
Tell your provider if you have an illness that results in severe vomiting, diarrhea, or fever, or if you have not been drinking much liquid lately.
This medicine is not recommended for people who are taking insulin or nitrates. Tell your healthcare provider if you are taking any medicines for heart failure, high blood pressure, high cholesterol, or for prevention of heart disease or stroke.
Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Talk to your healthcare provider about whether you will need to use insulin to control your blood sugar during pregnancy. Do not breast-feed while you are taking this medicine without your healthcare provider's approval.
Women who have not gone through menopause, or who do not have periods regularly or at all, may be able to become pregnant while taking this medicine. Talk to your healthcare provider about an effective method of birth control.
Check the label on the medicine for directions about your specific dose. Take this medicine every day exactly as your healthcare provider prescribes. Do not stop taking this medicine without your healthcare provider's approval. Take it with a meal. Follow carefully the diet and exercise plan your healthcare provider gives you. Diet and exercise affect your dosage.
Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.
If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.
If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.
Symptoms of an acute overdose may include: hunger, headache, confusion, irritability, drowsiness, weakness, dizziness, tremors, sweating, fast or slow heartbeat, seizures, fainting, coma, chills, muscle pain, shortness of breath, stomach pain, lightheadedness.
This medicine may cause or worsen heart failure. It may also increase your risk for a heart attack, stroke, or other heart problems, especially if you also take insulin or nitrate medicines. You will be required to review and sign a statement that you understand the risks. Talk with your healthcare provider about this.
Get medical care right away if you start having chest pain or pressure; shortness of breath; any unexplained swelling; or if you are gaining weight very fast. These may be symptoms of a serious heart problem.
You will need to have blood tests regularly to see if the medicine is working and to check for any signs of side effects that show up only on blood tests. You may be able to do your own testing for blood sugar levels on a small machine at home, but your healthcare provider will do other tests. People with diabetes should also have regular eye exams.
Lactic acidosis is a rare but serious complication that can occur with use of this medicine. This condition is caused by a buildup of lactic acid in the blood. This happens more often in people with kidney problems. Most people with kidney problems should not take this medicine. Stop taking this medicine and contact your healthcare provider right away if you develop unexplained symptoms such as:
Low blood sugar (hypoglycemia) can occur if you miss or delay meals, drink too much alcohol, take too much medicine, or exercise more than usual. Symptoms of low blood sugar include confusion, shaking, weakness, strong hunger, cold sweats, headache, nausea, vision problems, and feeling faint. Treat the condition quickly by eating or drinking something with sugar in it such as candy, juice, or nondiet soda. Taking glucose tablets or gels (available in drug stores) is another quick way to treat hypoglycemia. Be sure to talk about this with your healthcare provider.
Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.
Alcohol may affect the way your body responds to this medicine and to food. Do not drink alcohol unless your healthcare provider approves.
Rarely, this medicine may cause vision problems. You need to have regular eye exams while taking this medicine.
Some people, particularly women, are at higher risk of having bone fractures while taking this medicine. You may also need bone scans or X-rays to see if this medicine is affecting your bones. Talk to your healthcare provider about how to keep your bones healthy.
If you need emergency care, surgery, lab tests, X-rays, or dental work, tell the healthcare provider or dentist you are taking this medicine. Wear some form of ID stating that you are a diabetic (such as a Medic Alert bracelet). If you become unconscious, the ID tells emergency healthcare providers that you are a diabetic and need special care.
Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.
Life threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives, itching, rash, trouble breathing, tightness in your chest, swelling of your lips, tongue, and throat).
Serious (report these to your healthcare provider right away): Chest pain or pressure; muscle pain; trouble breathing or shortness of breath (especially when lying down); severe stomach pain; severe nausea or vomiting; extreme thirst; irregular heartbeat; severe dizziness; increasing drowsiness; loss of appetite; dark urine; light-colored bowel movements; yellowing of your eyes or skin; dark urine; unexplained tiredness; confusion; swelling of legs or ankles, or any unexplained swelling; unusual bruising or bleeding; vision problems; unusually fast weight gain.
Other: Mild nausea or vomiting, diarrhea, bloating, stuffy or runny nose, headache.
When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:
Do not drink large amounts of alcohol while you are taking this medicine. Talk to your healthcare provider about this.
Many medicines may change how well this medicine controls your blood sugar. Be sure to tell the healthcare provider who prescribed this medicine about any other medicines you are taking, including nonprescription products. Also, tell any other healthcare providers who treat you that you are taking this medicine for diabetes.
Many nonprescription products contain sugar, alcohol, or other ingredients that may interfere with this medicine or increase your blood sugar. Check product labels for warnings for diabetics or ask your healthcare provider or pharmacist for advice.
If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.
Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.
This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.
Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.
Keep all medicines out of the reach of children.
Do not share medicines with other people.
