What is the most important information I should know about Glucophage?

• Do not use Glucophage if you have kidney disease or congestive heart failure, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).
• Before taking Glucophage, tell your doctor if you have liver disease or a history of heart disease.
• Some people have developed a life-threatening condition called lactic acidosis while taking Glucophage. Get emergency medical help if you have any of these symptoms of lactic acidosis: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting.
• If you need to have any type of x-ray or CT scan using a dye that is injected into a vein, you may need to temporarily stop taking Glucophage. Be sure the surgeon knows ahead of time that you are using this medicaton.
• Know the signs of low blood sugar (hypoglycemia) and how to recognize them, including hunger, headache, confusion, irritability, drowsiness, weakness, dizziness, tremors, sweating, fast heartbeat, seizure (convulsions), fainting, or coma (severe hypoglycemia can be fatal). Always keep a source of sugar available in case you have symptoms of low blood sugar.

What is Glucophage?

• Glucophage is an oral diabetes medicine that helps control blood sugar levels.
• Glucophage is for people with type 2 diabetes who do not use daily insulin injections. This medication is not for treating type 1 diabetes.
• Glucophage may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Glucophage?

• Some people have developed a life-threatening condition called lactic acidosis while taking Glucophage. Get emergency medical help if you have any of these symptoms of lactic acidosis: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting.
• You may be more likely to develop lactic acidosis if you have congestive heart failure.
• Do not use Glucophage if you have kidney disease or congestive heart failure, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).
• Before taking this medication, tell your doctor if you have:
  • liver disease; or
  • a history of heart disease.
• If you have any of these conditions, you may not be able to use Glucophage, or you may need a dosage adjustment or special tests during treatment.
• FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
• It is not known whether Glucophage passes into breast milk or if it could harm a nursing baby. Do not take Glucophage without first talking to your doctor if you are breast-feeding a baby.
• Older adults may have a higher risk of developing lactic acidosis. Talk with your doctor about your individual risk.
• Glucophage should not be given to a child younger than 10 years old. Extended-release Glucophage (Glucophage XR) should not be given to a child younger than 17 years old.

How should I take Glucophage?

• Take this medication exactly as it was prescribed for you. Do not take the medication in larger or smaller amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from this medication.
• Take Glucophage once daily with your evening meal, unless your doctor tells you otherwise.
• Glucophage is only part of a complete program of treatment that also includes diet, exercise, and weight control. It is important to use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
• Do not crush, chew, or break an extended-release tablet (Glucophage XR). Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.
• To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your kidney function may also need to be tested. It is important that you not miss any scheduled visits to your doctor.
• Your medication needs may change if you become sick or injured, if you have a serious infection, or if you have any type of surgery. Your doctor may want you to stop taking Glucophage for a short time if any of these situations affect you.
• Take care not to let your blood sugar get too low, causing hypoglycemia. You may have hypoglycemia if you skip a meal, exercise too long, drink alcohol, or are under stress.
• Know the signs of low blood sugar (hypoglycemia) and how to recognize them:
  • hunger, headache, confusion, irritability;
  • drowsiness, weakness, dizziness, tremors;
  • sweating, fast heartbeat;
  • seizure (convulsions); or
  • fainting, coma (severe hypoglycemia can be fatal).
• Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.
• Your doctor may have you take extra vitamin B12 while you are taking Glucophage. Take only the amount of vitamin B12 that your doctor has prescribed.
• If you need to have any type of x-ray or CT scan using a dye that is injected into a vein, you may need to temporarily stop taking Glucophage. Be sure the surgeon knows ahead of time that you are using this medicaton.
• Store Glucophage at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

• Take the missed dose as soon as you remember (be sure to take the medicine with food). If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

• Seek emergency medical attention if you think you have used too much of this medicine. You may have signs of low blood sugar, such as hunger, headache, confusion, irritability, drowsiness, weakness, dizziness, tremors, sweating, fast heartbeat, seizure (convulsions), fainting, or coma.
• An overdose of Glucophage may cause a life-threatening condition called lactic acidosis. Get emergency medical help if you have any of these symptoms of lactic acidosis: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting.

What should I avoid while taking Glucophage?

• Avoid drinking alcohol while taking Glucophage. Alcohol lowers blood sugar and may increase the risk of lactic acidosis while you are taking this medicine.

What are the possible side effects of Glucophage?

• Get emergency medical help if you have any of these symptoms of lactic acidosis: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting.
• Stop using Glucophage and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
• Call your doctor at once if you have any of these serious side effects:
  • feeling short of breath, even with mild exertion;
  • swelling or rapid weight gain; or
  • fever, chills, body aches, flu symptoms.
• Other less serious side effects may be more likely to occur, such as:
  • headache;
  • weakness;
  • mild nausesa, vomiting, diarrhea, gas, stomach pain; or
  • muscle pain.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Glucophage?

• You may be more likely to have hyperglycemia (high blood sugar) if you are taking Glucophage with other drugs that raise blood sugar. Drugs that can raise blood sugar include:
  • isoniazid;
  • diuretics (water pills);
  • steroids (prednisone and others);
  • phenothiazines (Compazine and others);
  • thyroid medicine (Synthroid and others);
  • birth control pills and other hormones;
  • seizure medicines (Dilantin and others); and
  • diet pills, or medicines to treat asthma, colds or allergies.
• You may be more likely to have hypoglycemia (low blood sugar) if you are taking Glucophage with other drugs that lower blood sugar. Drugs that can lower blood sugar include:
  • nonsteroidal anti-inflammatory drugs (NSAIDs);
  • aspirin or other salicylates (including Pepto-Bismol);
  • sulfa drugs (Bactrim and others);
  • a monoamine oxidase inhibitor (MAOI);
  • beta-blockers (Tenormin and others);
  • probenecid (Benemid); or
  • a blood thinner (warfarin, Coumadin and others).
• Some medications may interact with Glucophage. Tell your doctor if you are using any of the following drugs:
  • furosemide (Lasix);
  • nifedipine (Adalat, Procardia);
  • cimetidine (Tagamet) or ranitidine (Zantac);
  • amiloride (Midamor) or triamterene (Dyrenium);
  • digoxin (Lanoxin);
  • morphine (MS Contin, Kadian, Oramorph);
  • procainamide (Procan, Pronestyl, Procanbid);
  • quinidine (Cardioquin, Quinidex, Quinaglute);
  • trimethoprim (Proloprim, Primsol, Bactrim, Cotrim, Septra); or
  • vancomycin (Vancocin, Lyphocin).
• If you are using any of these drugs, you may not be able to take Glucophage, or you may require a dosage adjustment or special monitoring.
• There may be other drugs not listed that can affect Glucophage. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.