Glucophage XR 500 mg ( Metformin Hydrochloride ) 30 film-coated tablets

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

WHAT IS METFORMIN?
Metformin is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Metformin is sometimes used together with insulin or other medications, but metformin is not for treating type 1 diabetes.

Metformin may also be used for purposes not listed in this medication guide.

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

Some people using metformin develop lactic acidosis, which can be fatal. Get emergency medical help if you have even mild symptoms such as:

unusual muscle pain;
feeling cold;
trouble breathing;
feeling dizzy, light-headed, tired, or very weak;
stomach pain, vomiting; or
slow or irregular heart rate.
Common side effects may include:

low blood sugar;
nausea, upset stomach; or
diarrhea.
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 METFORMIN?
You should not use this medicine if you have severe kidney disease, 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 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 METFORMIN?
You should not use metformin if you are allergic to it, or if you have:

severe kidney disease; or
metabolic acidosis or diabetic ketoacidosis (call your doctor for treatment).
If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking metformin. Be sure your caregivers know ahead of time that you are using this medication.

Tell your doctor if you have ever had:

kidney disease (your kidney function may need to be checked before you take this medicine);
high ketone levels in your blood or urine;
heart disease, congestive heart failure;
liver disease; or
if you also use insulin, or other oral diabetes medications.
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.

Follow your doctor's instructions about using this medicine if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy. Tell your doctor if you become pregnant while taking metformin.

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 using this medicine.

Metformin should not be given to a child younger than 10 years old. Some forms of metformin are not approved for use by anyone younger than 18 years old.

HOW SHOULD I TAKE METFORMIN?
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 metformin with a meal, unless your doctor tells you otherwise. Some forms of metformin are taken only once daily with the evening meal. Follow your doctor's instructions.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Some tablets are made with a shell that is not absorbed or melted in the body. Part of this shell may appear in your stool. This is normal and will not make the medicine less effective.

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.

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.

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.

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

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

WHAT HAPPENS IF I MISS A DOSE?
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?
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 METFORMIN?
Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.

WHAT OTHER DRUGS WILL AFFECT METFORMIN?
Many drugs can affect 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?
Your pharmacist can provide more information about 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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