Glucovance Patient, Information, Instructions - Glyburide and Metformin

Glucovance Patient, Information, Instructions - Glyburide and Metformin INFORMATION FOR PATIENTS

(Glyburide and Metformin HCl Tablets)

Q1. Why do I need to take GLUCOVANCE?

Your doctor has prescribed GLUCOVANCE to treat your type 2 diabetes. This is also known as non-insulin-dependent diabetes mellitus.

Q2. What is type 2 diabetes?

People with diabetes are not able to make enough insulin and/or respond normally to the insulin their body does make. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems including kidney damage, amputations, and blindness. Diabetes is also closely linked to heart disease. The main goal of treating diabetes is to lower your blood sugar to a normal level.

Q3. Why is it important to control type 2 diabetes?

The main goal of treating diabetes is to lower your blood sugar to a normal level. Studies have shown that good control of blood sugar may prevent or delay complications such as heart disease, kidney disease, or blindness.

Q4. How is type 2 diabetes usually controlled?

High blood sugar can be lowered by diet and exercise, by a number of oral medications, and by insulin injections. Before taking GLUCOVANCE you should first try to control your diabetes by exercise and weight loss. Even if you are taking GLUCOVANCE, you should still exercise and follow the diet recommended for your diabetes.

Q5. Does GLUCOVANCE work differently from other glucose-control medications?

Yes it does. GLUCOVANCE combines two glucose lowering drugs, glyburide and metformin. These two drugs work together to improve the different metabolic defects found in type 2 diabetes. Glyburide lowers blood sugar primarily by causing more of the body's own insulin to be released, and metformin lowers blood sugar, in part, by helping your body use your own insulin more effectively. Together, they are efficient in helping you achieve better glucose control.

Q6. What happens if my blood sugar is still too high?

When blood sugar cannot be lowered enough byGLUCOVANCE your doctor may prescribe injectable insulin or take other measures to control your diabetes.

Q7. Can GLUCOVANCE cause side effects?

GLUCOVANCE, like all blood sugar-lowering medications, can cause side effects in some patients. Most of these side effects are minor. However, there are also serious, but rare, side effects related to GLUCOVANCE (see Q9-Q13 ).

Q8. What are the most common side effects of GLUCOVANCE?

The most common side effects of GLUCOVANCE are normally minor ones such as diarrhea, nausea, and upset stomach. If these side effects occur, they usually occur during the first few weeks of therapy. Taking your GLUCOVANCE with meals can help reduce these side effects.

Less frequently, symptoms of hypoglycemia (low blood sugar), such as lightheadedness, dizziness, shakiness, or hunger may occur. The risk of hypoglycemic symptoms increases when meals are skipped, too much alcohol is consumed, or heavy exercise occurs without enough food. Following the advice of your doctor can help you to avoid these symptoms.

Q9. Are there any serious side effects that GLUCOVANCE can cause?

GLUCOVANCE rarely causes serious side effects. The most serious side effect that GLUCOVANCE can cause is called lactic acidosis.

Q10. What is lactic acidosis and can it happen to me?

Lactic acidosis is caused by a buildup of lactic acid in the blood. Lactic acidosis associated with metformin is rare and has occurred mostly in people whose kidneys were not working normally. Lactic acidosis has been reported in about one in 33,000 patients taking metformin over the course of a year. Although rare, if lactic acidosis does occur, it can be fatal in up to half the cases.

It's also important for your liver to be working normally when you take GLUCOVANCE. Your liver helps remove lactic acid from your bloodstream.

Your doctor will monitor your diabetes and may perform blood tests on you from time to time to make sure your kidneys and your liver are functioning normally.

There is no evidence that GLUCOVANCE causes harm to the kidneys or liver.

Q11. Are there other risk factors for lactic acidosis?

Your risk of developing lactic acidosis from taking GLUCOVANCE (Glyburide and Metformin HCl Tablets) is very low as long as your kidneys and liver are healthy. However, some factors can increase your risk because they can affect kidney and liver function. You should discuss your risk with your physician.

You should not take GLUCOVANCE if:

Q12. What are the symptoms of lactic acidosis?

Some of the symptoms include: feeling very weak, tired or uncomfortable; unusual muscle pain, trouble breathing, unusual or unexpected stomach discomfort, feeling cold, feeling dizzy or lightheaded, or suddenly developing a slow or irregular heartbeat.

If you notice these symptoms, or if your medical condition has suddenly changed, stop taking GLUCOVANCE tablets and call your doctor right away. Lactic acidosis is a medical emergency that must be treated in a hospital.

Q13. What does my doctor need to know to decrease my risk of lactic acidosis?

Tell your doctor if you have an illness that results in severe vomiting, diarrhea, and/or fever, or if your intake of fluids is significantly reduced. These situations can lead to severe dehydration, and it may be necessary to stop taking GLUCOVANCE temporarily.

You should let your doctor know if you are going to have any surgery or specialized x-ray procedures that require injection of contrast agents. GLUCOVANCE therapy will need to be stopped temporarily in such instances.

Q14. Can I take GLUCOVANCE with other medications?

Remind your doctor that you are taking GLUCOVANCE when any new drug is prescribed or a change is made in how you take a drug already prescribed. GLUCOVANCE may interfere with the way some drugs work and some drugs may interfere with the action of GLUCOVANCE.

Q15. What if I become pregnant while taking GLUCOVANCE?

Tell your doctor if you plan to become pregnant or have become pregnant. As with other oral glucose-control medications, you should not take GLUCOVANCE during pregnancy.

Usually your doctor will prescribe insulin while you are pregnant. As with all medications, you and your doctor should discuss the use of GLUCOVANCE if you are nursing a child.

Q16. How do I take GLUCOVANCE?

Your doctor will tell you how many GLUCOVANCE tablets to take and how often. This should also be printed on the label of your prescription. You will probably be started on a low dose of GLUCOVANCE and your dosage will be increased gradually until your blood sugar is controlled.

Q17. Where can I get more information about GLUCOVANCE?

This leaflet is a summary of the most important information about GLUCOVANCE. If you have any questions or problems, you should talk to your doctor or other healthcare provider about type 2 diabetes as well as GLUCOVANCE and its side effects. There is also a leaflet (package insert) written for health professionals that your pharmacist can let you read.

Patients should be informed of the potential risks and benefits of GLUCOVANCE and of alternative modes of therapy. They should also be informed about the importance of adherence to dietary instructions, of a regular exercise program, and of regular testing of blood glucose, glycosylated hemoglobin, renal function, and hematologic parameters.

The risks of lactic acidosis associated with metformin therapy, its symptoms, and conditions that predispose to its development, as noted in the WARNINGS and PRECAUTIONS sections, should be explained to patients. Patients should be advised to discontinue GLUCOVANCE (Glyburide and Metformin HCl Tablets) immediately and to promptly notify their health practitioner if unexplained hyperventilation, myalgia, malaise, unusual somnolence, or other nonspecific symptoms occur. Once a patient is stabilized on any dose level of GLUCOVANCE, gastrointestinal symptoms, which are common during initiation of metformin therapy, are unlikely to be drug related. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease.

The risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and responsible family members.

Patients should be counseled against excessive alcohol intake, either acute or chronic, while receiving GLUCOVANCE.

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