Sandoz Metformin XR: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Sandoz Metformin XR 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:

Sandoz Metformin XR (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 Sandoz Metformin XR if:

• You have a known allergy to metformin or any ingredients found in Sandoz Metformin XR extended-release tablets
• 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
• You have severe liver dysfunction
• You have cardiovascular collapse or cardiorespiratory insufficiency
• You have kidney disease or impairment
• You drink 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 nonmedicinal ingredients are:

Sandoz Metformin XR 500 mg: colloidal anhydrous silica, hypromellose, macrogol/PEG, magnesium stearate, povidone, titanium dioxide.

Sandoz Metformin XR 1000 mg: colloidal anhydrous silica, hypromellose, macrogel/PEG, magnesium stearate, povidone, titanium dioxide.

For a full listing of nonmedicinal ingredients see Part 1 of the product monograph.

What dosage forms it comes in:

Extended Release tablets: Each tablet contains 500 mg or 1000 mg metformin hydrochloride.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Sandoz Metformin XR may rarely be associated with a serious, life-threatening condition called lactic acidosis (see Lactic Acidosis below).

You should not drink a lot of alcohol if you take Sandoz Metformin XR (see section Lactic Acidosis below).

BEFORE you use Sandoz Metformin XR talk to your doctor or pharmacist if you have:

• a history of kidney disease
• are 80 years or older and you have NOT had your kidney function tested
• liver disease
• 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 or folic acid deficiency
• drink alcohol

Lactic Acidosis

Sandoz Metformin XR therapy may rarely be associated with a serious, life-threatening condition called lactic acidosis.

Due to potential for lactic acidosis, you should talk to your doctor if you take Sandoz Metformin XR and if you:

• develop or experience a worsening of heart disease and particularly heart failure
• develop a serious medical condition, such as heart attack, severe infection, or a stroke

Signs and symptoms of lactic acidosis include: discomfort, muscle pain, difficult or fast breathing, extreme tiredness, weakness, upset stomach, stomach pain, feeling cold, low blood pressure or slow or irregular heartbeat.

If any of the above side effects occur, contact your doctor immediately.

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 increase blood sugar levels such as ‘water pills’ (diuretics), birth control pills, sympathomimetics (decongestants), thyroid medicines, prednisone (corticosteroid drugs), phenytoin, nicotinic acid, certain drugs which control high blood pressure (eg calcium channel blockers), and isoniazid
• furosemide
• nifedipine
• cationic drugs which may interfere with the elimination of metformin (eg. cimetidine, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, 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 common 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).

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

Reporting Side Effects

HOW TO STORE IT

This medicine should be stored at room temperature

(15^oC - 30^oC). Keep out of reach and sight of children.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Sandoz Canada Inc., at:

1-800-361-3062

or by written request at:

145 Jules-Léger

Boucherville Québec, Canada

J4B 7K8

or by e-mail at :

medinfo@sandoz.com

Last revised: June 8, 2021