Glucovance 500 / 5 mg ( Metformin / Glyburide ) 30 film-coated tablets

Brand Names: Glucovance
Generic Name: glyburide and metformin

What is glyburide and metformin (Glucovance)?
What are the possible side effects of glyburide and metformin (Glucovance)?
What is the most important information I should know about glyburide and metformin (Glucovance)?
What should I discuss with my healthcare provider before taking glyburide and metformin (Glucovance)?
How should I take glyburide and metformin (Glucovance)?
What happens if I miss a dose (Glucovance)?
What happens if I overdose (Glucovance)?
What should I avoid while taking glyburide and metformin (Glucovance)?
What other drugs will affect glyburide and metformin (Glucovance)?
Where can I get more information (Glucovance)?

WHAT IS GLYBURIDE AND METFORMIN (GLUCOVANCE)?
Glyburide and metformin is a combination of two oral diabetes medicines that help control blood sugar levels.

Glyburide and metformin is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes. This medicine is not for treating type 1 diabetes.

Glyburide and metformin may also be used for purposes not listed in this medication guide.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF GLYBURIDE AND METFORMIN (GLUCOVANCE)?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

heart problems-- swelling, rapid weight gain, feeling short of breath;
severe hypoglycemia--extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, seizure; or
lactic acidosis--unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.
Common side effects may include:

low blood sugar;
nausea, diarrhea, upset stomach; or
headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT GLYBURIDE AND METFORMIN (GLUCOVANCE)?
You should not use this medicine if you have severe kidney disease, if you also take bosentan (Tracleer), or if you have metabolic acidosis or diabetic ketoacidosis (call your doctor for treatment).

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking glyburide and metformin.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

WHAT SHOULD I DISCUSS WITH MY HEALTHCARE PROVIDER BEFORE TAKING GLYBURIDE AND METFORMIN (GLUCOVANCE)?
You should not use this medicine if you are allergic to glyburide or metformin, or:

severe kidney disease;
metabolic acidosis or diabetic ketoacidosis (call your doctor for treatment); or
if you are also using bosentan (to treat pulmonary arterial hypertension).
If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking glyburide and metformin.

Tell your doctor if you have ever had:

kidney disease;
an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD);
liver disease; or
heart disease, heart attack, or stroke.
You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.

It is not known whether glyburide and metformin will harm an unborn baby. Similar diabetes medications have caused severe hypoglycemia in newborn babies whose mothers had used the medication near the time of delivery. Tell your doctor if you are pregnant or plan to become pregnant.

Metformin may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

You should not breastfeed while taking glyburide and metformin.

HOW SHOULD I TAKE GLYBURIDE AND METFORMIN (GLUCOVANCE)?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take glyburide and metformin with meals.

Drink plenty of liquids while you are taking glyburide and metformin.

Call your doctor if you are sick with vomiting, diarrhea, or a fever. These conditions can lead to severe dehydration, which could be dangerous while you are taking glyburide and metformin.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Glyburide and metformin is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Your doctor may have you take extra vitamin B12 while you are taking glyburide and metformin. Take only the amount of vitamin B12 that your doctor has prescribed.

Store at room temperature away from moisture, heat, and light.

WHAT HAPPENS IF I MISS A DOSE (GLUCOVANCE)?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

WHAT HAPPENS IF I OVERDOSE (GLUCOVANCE)?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can cause severe hypoglycemia or lactic acidosis.

WHAT SHOULD I AVOID WHILE TAKING GLYBURIDE AND METFORMIN (GLUCOVANCE)?
Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.

If you also take colesevelam, avoid taking it within 4 hours after you take glyburide and metformin.

WHAT OTHER DRUGS WILL AFFECT GLYBURIDE AND METFORMIN (GLUCOVANCE)?
Many drugs can affect glyburide and metformin, making this medicine less effective or increasing your risk of lactic acidosis. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

WHERE CAN I GET MORE INFORMATION (GLUCOVANCE)?
Your pharmacist can provide more information about glyburide and metformin.

REMEMBER, KEEP THIS AND ALL OTHER MEDICINES OUT OF THE REACH OF CHILDREN, NEVER SHARE YOUR MEDICINES WITH OTHERS, AND USE THIS MEDICATION ONLY FOR THE INDICATION PRESCRIBED.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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