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Glucovance Consumer Information

GLUCOVANCE

Generic Name: glyburide and metformin (GLYE byoor ide and met FORE min)

Brand Names: Glucovance

What is the most important information I should know about glyburide and metformin?

• A small number of people who have taken metformin have developed a serious condition called lactic acidosis that has been fatal in up to 50% of cases. Lactic acidosis has occurred most often in people whose kidneys were not working properly. Liver problems may also increase the risk of developing lactic acidosis. Stop taking glyburide and metformin and call your doctor immediately if you experience a feeling of general discomfort or sickness; weakness; sore or aching muscles; trouble breathing, unusual drowsiness, dizziness or lightheadedness; unusual or unexplained stomach upset (after the initial stomach upset that may occur at the start of therapy with glyburide and metformin); or the sudden development of a slow or irregular heartbeat. These may be signs of lactic acidosis.
• Avoid excessive alcohol intake while taking glyburide and metformin. Together, alcohol and glyburide and metformin may increase the risk of lactic acidosis and hypoglycemia.
• Know the signs and symptoms of low blood sugar (hypoglycemia), which include hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of hard candy or glucose tablets with you to treat episodes of low blood sugar.

What is glyburide and metformin?

• Glyburide is in a class of drugs called sulfonylureas. It is used to help control blood sugar levels by stimulating the pancreas to release more insulin into the blood.
• Metformin is also used to regulate blood sugar levels. Metformin works in three ways: first, it reduces the amount of glucose (sugar) produced by your liver; second, it reduces the amount of glucose absorbed from food through your stomach; and third, it makes the insulin that your body produces work better to reduce the amount of glucose already in your blood.
• Glyburide and metformin is used with diet and exercise to treat non-insulin-dependent (type 2) diabetes.
• Glyburide and metformin may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking glyburide and metformin?

• Do not take glyburide and metformin without first talking to your doctor if you
• are allergic to either glyburide (Diabeta, Micronase, Glynase) or metformin (Glucophage);
• have kidney disease;
• have liver disease;
• have congestive heart failure;
• have acute or chronic metabolic acidosis, including diabetic ketoacidosis;
• have had a heart attack or a stroke;
• have a serious infection, illness, or injury;
• need to have surgery;
• need to have x-rays or other procedures using injectable contrast agents;
• are dehydrated due to diarrhea, vomiting, fever, heat stroke, decreased fluid intake, or any other cause;
• drink alcohol; or
• are 80 years of age or older and have not had your kidney function tested.
• You may not be able to take glyburide and metformin, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
• Glyburide and metformin is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Usually, your doctor will want to prescribe insulin to control diabetes during pregnancy. Do not take glyburide and metformin without first talking to your doctor if you are pregnant.
• Glyburide and metformin passes into breast milk and may affect a nursing baby. Do not take glyburide and metformin without first talking to your doctor if you are breastfeeding a baby.
• If you are over the age of 65 years, there may be an increase in the risk of developing lactic acidosis due to a natural decline in kidney function with advancing age. Your doctor may prescribe a lower dose or special monitoring during your treatment.

How should I take glyburide and metformin?

• Take glyburide and metformin exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take each dose with a full glass of water.
• Take glyburide and metformin with a meal to reduce nausea, diarrhea, and upset stomach that may occur with glyburide and metformin therapy. These symptoms may be more likely to occur during the first few weeks of therapy.
• A decrease in vitamin B12 may also occur during therapy with glyburide and metformin. Your doctor may want to monitor your blood levels of vitamin B12 and you may need to take B12 supplements. A vitamin B12 deficiency may rarely cause anemia.
• Follow your diet, medication, and exercise routines very closely. Changing any of these things can effect your blood sugar levels.
• Know the signs and symptoms of low blood sugar (hypoglycemia), which include hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of hard candy or glucose tablets with you to treat episodes of low blood sugar.
• Your doctor may want to monitor your blood sugar control and other factors with regularly scheduled blood tests.
• Store glyburide and metformin at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

• Seek emergency medical attention.
• Symptoms of a glyburide and metformin overdose include hunger, nausea, anxiety, cold sweats, weakness, drowsiness, unconsciousness, and coma. An overdose of glyburide and metformin may also cause lactic acidosis. Symptoms of lactic acidosis include a feeling of general discomfort or sickness; weakness; sore or aching muscles; trouble breathing; unusual drowsiness, dizziness or lightheadedness; unusual or unexplained stomach upset (after the initial stomach upset that may occur at the start of therapy with glyburide and metformin); and the sudden development of a slow or irregular heartbeat.

What should I avoid while taking glyburide and metformin?

• Avoid excessive alcohol intake while taking glyburide and metformin. Together, alcohol and glyburide and metformin may increase the risk of lactic acidosis and hypoglycemia.
• Follow your diet, medication, and exercise routines very closely. Changing any of these things can effect your blood sugar levels.
• Tell your doctor or other health care provider that you are taking this medication if you need to have surgery or x-ray procedures that require injection of contrast agents. Treatment with glyburide and metformin may need to be stopped for a short period of time.
• Tell your doctor that you are taking glyburide and metformin if you become ill, if you have a heart attack; if you have a stroke; if you develop congestive heat failure; if you experience diarrhea, vomiting, fever, or dehydration from any cause; or if you decrease the amount of food or liquid in your normal diet. You may need to stop your treatment with glyburide and metformin for a short amount of time until you are feeling better.
• Do not take any over-the-counter cough, cold, allergy, pain, or weight loss medications without first talking to your doctor.