Details for: APO-METFORMIN ER
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02460653 | APO-METFORMIN ER | METFORMIN HYDROCHLORIDE | 1000 MG | TABLET (EXTENDED-RELEASE) | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
APO-METFORMIN ER 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
APO-METFORMIN ER (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 APO-METFORMIN ER if:
- You have a known allergy to metformin or any ingredients found in APO-METFORMIN ER 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 non-medicinal ingredients are
APO-METFORMIN ER 500 mg: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, titanium dioxide.
APO-METFORMIN ER 1000 mg: carbomer homopolymer Type A, carbomer homopolymer Type B, dibutyl sebacate, ethyl cellulose, hydroxypropyl methylcellulose, magnesium stearate
For a full listing of nonmedicinal ingredients see Part 1 of the product monograph.
What dosage form it comes in
Extended Release tablets: Each tablet contains 500 mg or 1000 mg metformin hydrochloride.
Warnings and precautions
Serious Warnings and Precautions
APO-METFORMIN ER 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 APO-METFORMIN ER (see section Lactic Acidosis below).
BEFORE you use APO-METFORMIN ER 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
APO-METFORMIN ER 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 APO-METFORMIN ER 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.
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).
Side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Uncommon | |||
Lactic acidosis (a buildup of an acid in the blood) that can cause death or cardiovascular mortality Symptoms include:
|
✔ | ✔ | |
This is not a complete list of side effects. For any unexpected effects while taking APO-METFORMIN ER, contact your doctor or pharmacist.
How to store
This medicine should be stored at room temperature 15oC - 30oC. Keep out of reach of children.
Reporting side effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect (hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 1908C
Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
For more information, please contact your doctor, pharmacist or other healthcare professional.
This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting DISpedia, Apotex's Drug Information Service at:
1-800-667-4708
This leaflet can also be found at: http://www.apotex.ca/products.
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.
Last prepared: January 12, 2017