Glucophage XR

Glucophage XR is used along with diet and exercise to help manage blood sugar levels in patients with type 2 diabetes mellitus (not for type 1 diabetes).

Glucophage XR may also be used for other reasons that are not mentioned in this medication guide.

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.

Your dose needs may change if you switch to a different brand, strength, or form of Glucophage XR. Avoid medication errors by using it exactly as directed on the label, or as prescribed by your doctor.

Take Glucophage XR 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.

Swallow the tablet whole and do not crush, chew, or break it.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

Part of a tablet shell may appear in your stool but this will not make the medicine less effective.

Blood sugar can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals.

Low blood sugar (hypoglycemia) can make you feel very hungry, dizzy, irritable, or shaky. To quickly treat hypoglycemia, eat or drink hard candy, crackers, raisins, fruit juice, or non-diet soda. Your doctor may prescribe glucagon injection in case of severe hypoglycemia.

Tell your doctor if you have frequent symptoms of high blood sugar (hyperglycemia) such as increased thirst or urination. Ask your doctor before changing your medication dosage.

Your blood sugar will need to be checked on a regular basis, and you may need other medical tests including checking your kidney function.

You may be given other medications to help with your condition. Keep taking these medicines for as long as your doctor has prescribed.

Your treatment may also include diet, exercise, weight control, medical tests, and special medical care.

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

You should not use Glucophage XR if you have severe kidney disease, metabolic acidosis, or diabetic ketoacidosis (call your doctor for treatment).

You may develop lactic acidosis, which is 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.

You should not use Glucophage XR if you are allergic to it, or if you have:

• severe kidney disease; or
• metabolic acidosis or diabetic ketoacidosis (call your doctor for treatment).

Tell your doctor if you have or have ever had:

• high ketone levels in your blood or urine;
• low levels of vitamin B12;
• heart problems such as heart attack, heart failure, or stroke;
• if you also use insulin, or other oral diabetes medications;
• if you are dehydrated;
• if you drink large amounts of alcohol; or
• liver or kidney disease.

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.

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 Glucophage XR. Make sure that your healthcare provider knows ahead of time that you are using this medication.

It is not known if Glucophage XR will harm an unborn baby. Follow your doctor's instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy.

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

Ask a doctor if it is safe to breastfeed while using this medicine.

Glucophage XR 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.

Get emergency medical help if you notice signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

Some people taking Glucophage XR can develop lactic acidosis, which can be life-threatening. Seek emergency medical help if you experience: unusual muscle pain, trouble breathing, stomach pain, vomiting, fast or slow irregular heartbeats, dizziness, feeling cold, or feeling very weak or tired.

Glucophage XR may lead to serious side effects. Contact your doctor immediately if you have:

• severely low blood sugar—extreme weakness, confusion, tremors, sweating, fast heartbeats, difficulty speaking, nausea, vomiting, rapid breathing, fainting, or seizures (convulsions).

Common side effects of Glucophage XR may include:

• low blood sugar;
• dizziness, weakness or lack of energy;
• headache;
• altered sense of taste;
• stomach pain or upset, heartburn;
• indigestion, bloating, gas, nausea, vomiting, constipation, diarrhea; or
• cold symptoms like stuffy nose, sneezing, sore throat.

This is not a complete list of side effects, and others may occur. Contact your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Take the medicine as soon as possible, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at once.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Do not drink alcohol. It can lower your blood sugar and may increase your risk of lactic acidosis.

Many medicines can raise your risk of lactic acidosis or impact your blood sugar and may also affect Glucophage XR. This includes both prescription and over-the-counter medicines, as well as vitamins and herbal products. Inform your doctor about all other medicines you are using. Not all possible interactions are included here.