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Patient Information

This information is Part 3 of a three-part “Product Monograph” published when GLUMETZA was approved for sale in Canada and is designed specifically for consumers. The following information is a summary for consumers and will not tell you everything about GLUMETZA. Contact your doctor or pharmacist if you have any questions about the drug.

ABOUT THIS MEDICATION:

What the medication is used for: GLUMETZA extended-release tablets are used in addition to diet and exercise, to improve blood sugar levels in adults with type 2 diabetes. People with type 2 diabetes are not able to make enough insulin and they do not respond normally to the insulin that their bodies make.

What it does: GLUMETZA (metformin hydrochloride) extended-release tablets work to control your blood sugar by:

• Helping insulin, naturally produced by your body, be more effective
• Decreasing the amount of sugar your liver makes
• Decreasing the amount of sugar your intestines absorb

When it should not be used:

Do not use GLUMETZA if:

• You have a known allergy to metformin or any ingredients found in GLUMETZA extended-release tablets (see GLUMETZA ingredients, below)
• You have unstable or Type 1 (insulin-dependent) diabetes
• You have acute or chronic metabolic acidosis or diabetic ketoacidosis, with or without coma
• You have a history of lactic acidosis (see Warnings and Precautions)
• You have severe liver dysfunction
• You have congestive heart failure requiring ongoing treatment with drugs
• You have cardiovascular collapse or cardiorespiratory insufficiency
• You have kidney disease or impairment
• You drink a lot of alcohol
• You are going to have an x-ray procedure with injection of iodinated contrast materials
• Prior to surgery or during your recovery phase
• You have a severe infection
• You have severe dehydration (have lost a lot of water from your body)
• You are pregnant or planning to become pregnant

What the medicinal ingredient is: Each tablet contains 500 mg or 1000 mg metformin hydrochloride

What the important non-medicinal ingredients are:

GLUMETZA 500 mg: hypromellose, microcrystalline cellulose, magnesium stearate, polyethylene glycol, polyethylene oxide, polysorbate, titanium dioxide.

GLUMETZA 1000 mg: colloidal silicon dioxide, crospovidone, glyceryl behenate, polyvinyl alcohol, polyacrylate dispersion, hypromellose, talc, polyethylene glycol, titanium dioxide, simethicone emulsion, polysorbate, shellac glaze, iron oxide black, macrogol, n-butyl alcohol, propylene glycol, FD&C blue #2, FD&C yellow #6 and FD&C red #40.

What dosage forms it comes in: Extended Release tablets: Each tablet contains 500 mg or 1000 mg metformin hydrochloride.

WARNINGS AND PRECAUTIONS: These drugs are not for everyone. In rare cases, these drugs may cause lactic acidosis (buildup of lactic acid in the blood), which is serious and can be fatal in some cases. Seek immediate medical attention if you develop any of the following symptoms of lactic acidosis: unusual tiredness (fatigue) or severe drowsiness, cold skin, breathing problems or rapid breathing, unusually slow or irregular heartbeat. Lactic acidosis is more likely to occur in people whose kidneys are not functioning properly. Tell your doctor about your alcohol use because it can increase your risk. You should not take these drugs if: You have kidney problems. You are 80 years or older and have not had your kidneys tested. You are taking medication for heart failure. You are seriously dehydrated. You have a severe infection. You have or have had liver disease. Before you use GLUMETZA, talk to your doctor or pharmacist if you have: A history of kidney disease Liver disease Congestive heart failure Metabolic acidosis (e.g., diabetic ketoacidosis) Recent heart attack Recent stroke Serious infection Dehydration Scheduled surgery Scheduled x-ray or scanning procedures Are pregnant, breast-feeding, or planning to become pregnant Vitamin B12 deficiency or folic acid deficiency Drink alcohol

INTERACTIONS WITH THIS MEDICATION: Always inform your doctor or pharmacist of all prescription over-the-counter, and herbal medicines that you are taking.

Medicines which may require additional monitoring of your dose or condition include:

• Other diabetes drugs, such as glyburide, insulin, and rosiglitazone;
• Medications that may elevate blood sugar levels such as water pills (diuretics), birth control pills, sympathomimetics (decongestants), thyroid medicines, predinisone (corticosteroid drugs), phenytoin, nicotinic acid, certain drugs which control high blood pressure (e.g., calcium channel blockers), and isoniazid;
• Furosemide;
• Nifedipine;
• Cationic drugs which may interfere with the elimination of metformin (e.g. cimetidine, amiloride, digoxin, morphine, procainimide, quinidine, quinine, rantidine, triamterene, trimethoprim, vancomycin);
• Certain “blood thinners” (coumarin-type anticoagulants);
• Alcohol.

Interactions with herbal products have not been established.

PROPER USE OF THIS MEDICATION:

Follow the directions provided by your doctor for using this medicine. Only take this medicine with food, and drink plenty of fluids while taking this medicine. Do not miss any doses. Swallow whole. Do not break or crush tablets.

Usual dose: Initial dose is 1000 mg with evening meal. Maximum daily dose is 2000 mg.

Overdose: If an overdose is suspected, contact your local poison control centre or emergency immediately. Symptoms of overdose may include rapid breathing or trouble in breathing, nausea and vomiting followed by diarrhea, drowsiness, weakness, dizziness, and headache.

Missed Dose: If a dose of this medication has been missed it should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not double doses. If you do not feel well or your home glucose test shows higher levels, contact your physician.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM:

Some possible side effects include diarrhea, nausea and stomach upset. If they continue or are bothersome, check with your doctor.

After you are on the same dose for several days or weeks, if any of these symptoms come back, tell your doctor immediately. A late recurrence of stomach symptoms may be due to a serious medical condition (lactic acidosis).

Remember, your doctor or other healthcare professional is the best source of information regarding you and your health. Please consult with your doctor or other healthcare professional if you have any questions about your health or medication.

This is not a complete list of side effects. For any unexpected effects while taking GLUMETZA contact your doctor or pharmacist.

HOW TO STORE IT: This medicine should be stored at room temperature (15-30ºC). Keep out of reach of children.

REPORTING SUSPECTED SIDE EFFECTS: To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

Toll-free telephone: 866-234-2345

Toll-free fax: 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre
Marketed Health Products
Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C,
Ottawa, ON,
K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INORMATION: This document plus the full product monograph, prepared for health professionals can be found at http://www.biovail.com or by contacting the sponsor, Biovail Pharmaceuticals Canada, at 1 866 825-8120 or via e-mail at MedInfo@Biovail.com.

Product information on this page is intended for residents of Canada only. Residents of the U.S. should return to the User Profile Selection page and select accordingly.