Patient Medication Information: uses, side effects, how to take - Mint-Metformin XR

Serious warnings and precautions box

Lactic Acidosis

MINT-METFORMIN XR may cause lactic acidosis. This is a serious condition when there is too much lactic acid in your body. It may cause death.
The risk of lactic acidosis is higher if you:
- have liver, kidney or heart problems, including heart failure.
- drink a lot of alcohol. You should not drink alcohol while taking MINT-METFORMIN XR
Stop taking MINT-METFORMIN XR right away and talk to your healthcare professional if you have these symptoms:
- discomfort, muscle pain, difficult or fast breathing, extreme tiredness, weakness, upset stomach, stomach pain, feeling cold, low blood pressure or slow heartbeat.
MINT-METFORMIN XR can also cause diarrhea, nausea, upset stomach, bloating, gas or loss of appetite.
- If any of these side effects come back after you are on the same dose of MINT-METFORMIN XR for many days or weeks, tell your healthcare professional right away. These symptoms may be due to lactic acidosis.

Lactic acidosis must be treated in the hospital. Your healthcare professional will decide the best treatment options for you.

What MINT-METFORMIN XR is used for:

MINT-METFORMIN XR are used in addition to diet and exercise to improve blood sugar levels in adults with type 2 diabetes mellitus. MINT-METFORMIN XR can be used with other antidiabetic medicines or by itself.

How MINT-METFORMIN XR works:

MINT-METFORMIN XR helps control your blood sugar. It is believed to help your body respond better to the insulin it makes naturally.

High blood sugar can be lowered by diet and exercise, by a number of medicines taken by mouth, and by insulin shots. While you take MINT-METFORMIN XR continue to exercise and follow the diet advised by your doctor for your diabetes.

The ingredients in MINT-METFORMIN XR are:

Medicinal ingredients: metformin hydrochloride

Non-medicinal ingredients

MINT-METFORMIN XR 500 mg: Hypromellose, Macrogol/PEG, Magnesium Stearate, Microcrystalline Cellulose, Titanium Dioxide

MINT-METFORMIN XR 1000 mg: Acetone, Ammonio methacrylate copolymer Type A, Dibutyl Sebacate, Isopropyl Alcohol, Hypromellose, Macrogol/PEG, Magnesium Stearate, Microcrystalline Cellulose, Titanium Dioxide.

Do not use MINT-METFORMIN XR if:

you have a known allergy to metformin, or any other ingredients in MINT-METFORMIN XR extended-release tablets
you have Type 1 diabetes that is unstable and / or insulin dependent.
you have metabolic acidosis (including diabetic ketoacidosis or a history of ketoacidosis, with or without coma
you have a history of lactic acidosis (too much acid in the blood)
you have severe liver problems
you have heart system collapse (blood circulation failure) or heart problems that can cause hypoxemia (low oxygen in the blood)
you regularly drink alcohol
you are going to get injection of dyes (iodinated contrast materials)
you are stressed, have a severe infection, or are experiencing trauma
you will have surgery and during recovery after your surgery
you have severe dehydration (have lost a lot of water from your body) or shock
you are pregnant or planning to become pregnant
you are breast feeding

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take MINT-METFORMIN XR. Talk about any health conditions or problems you may have, including if you:

have a history of kidney problem
are 80 years or older and you have NOT had your kidney function tested
have liver problems
have a condition called metabolic acidosis (e.g. diabetic ketoacidosis). This is when you have too much acid in the blood
have had a recent heart attack
have had recent stroke
have a serious infection
are dehydrated
are scheduled for surgery
are scheduled for and x-ray or scanning procedures
are pregnant, breast-feeding or planning to become pregnant
have vitamin B12 or folic acid deficiency
drink alcohol
have hormone problems (adrenal or pituitary glands)
have low blood sugar
have a low daily calorie intake
have a genetic disease affecting mitochondria (the energy producing components within cells) such as
- MELAS syndrome (Mitochondrial Encephalopathy, myopathy, Lactic acidosis and Stroke-like episodes) or
- Maternal inherited diabetes and deafness (MIDD)
have any of these symptoms after starting MINT-METFORMIN XR: seizures, declined cognitive abilities, difficulty with body movements, symptoms indicating nerve damage (e.g. pain or numbness), migraine and deafness

Other warnings you should know about:

Vitamin B₁₂levels:
- MINT-METFORMIN XR can cause your vitamin B12 levels to be low. This can cause peripheral neuropathy (nerve damage).
Thyroid problems:
- MINT-METFORMIN XR can cause hypothyroidism (low thyroid hormone levels) if:
  - you have thyroid problems or if you are being treated with levothyroxine (a drug used to treat thyroid problems).
- Your healthcare professional will monitor your thyroid health during treatment.
- Nerve damage
  - MINT-METFORMIN XR can cause seizure, declined cognitive abilities, difficulty with body movements, symptoms indicating nerve damage (e.g. pain or numbness), migraine and deafness

See the “Serious side effects and what to do about them” table, below, for more information on these and other serious side effects.

Hyperglycemia (low blood sugar):
- MINT-METFORMIN XR rarely causes hypoglycemia (low blood sugar) by itself.
- Hypoglycemia can happen if you:
  - do not eat enough
  - drink alcohol
  - take other medicines to lower blood sugar.
  - have hormone (adrenal or pituitary gland) or liver problems
Check-ups and testing: You will have regular visits with your healthcare professional, before, during and at the end of your treatment. They will:
- Do blood and urine tests to check your blood health and sugar levels.
- Check that your heart, eyes, thyroid and liver are working properly.
- Check your kidney health before starting treatment and every 6 months during treatment with MINT-METFORMIN XR.
Patients older than 65 years old:
- You should not take MINT-METFORMIN XR if you are older than 80 years old unless certain tests are done to check your kidney health.
Pregnancy and breastfeeding:

Female patients

Do not take MINT-METFORMIN XR if you are pregnant. It may harm your unborn baby.
Tell your healthcare professional right away if you become pregnant or think you may be pregnant during your treatment with MINT-METFORMIN XR.
Do not breastfeed while you are taking MINT-METFORMIN XR.
Driving and using machines: Do not drive or operate machines if you develop hypoglycemia (low blood sugar levels)

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with MINT-METFORMIN XR:

Other diabetes drugs, such as glyburide, insulin, and rosiglitazone
Cationic drugs which may interfere with the elimination of metformin (cimetidine) ,
Intravenous contrast dyes (such as intravenous urogram, intravenous cholangiography, angiography, and computed tomography (CT) scans with intravascular contrast material)
Alcohol
Nifedipine and calcium channel blockers, used to treat high blood pressure
Medicines used to treat heart failure and irregular heartbeats like digoxin
Medicines used to treat pain like morphine
Medicines used to treat irregular heartbeats like procainamide , quinidine
Medicines used to lower stomach acid like ranitidine
Medicine used to treat malaria like quinine
Medicines used to treat bacterial infections (antibiotics) like trimethoprim, vancomycin
Medicines used as blood thinners like phenprocoumon
Medicines used to lower the extra fluid in your body (diuretics), like furosemide, amiloride, triamterene
Medicines that create high blood sugar and may lead to a loss of blood sugar control. Examples include:
- Furosemide (water pills)
- Thiazide and other diuretics (used to lower the extra fluid in your body)
- Phenytoin, used to treat epilepsy
- Nicotinic acid, used to prevent and treat low niacin
- Isoniazid, used to treat active tuberculosis infections
- Corticosteroids (anti-inflammatory drugs) like prednisone
- Phenothiazines, used to treat mental and emotional disorders
- Thyroid hormone drugs, like levothyroxine
- Female hormones like estrogens or estrogens plus progestogen
- Oral birth control
- Sympathomimetics (used to stimulate the sympathetic nervous system)
- Medicines for asthma such as salbutamol

How to take MINT-METFORMIN XR:

Follow the directions provided by your healthcare professional for using this medicine. Check with your healthcare professional if you are not sure.
Swallow tablets whole. Do not break or crush tablets.
Take by mouth with food or with a glass of water, and drink plenty of fluids.
Do not miss any doses.

Usual dose:

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

Overdose:

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 you miss a dose of MINT-METFORMIN XR

Do not take a double dose
Take the next dose at the usual time

If you do not feel well or your home glucose test shows higher levels, contact your healthcare professional.

Possible side effects from using MINT-METFORMIN XR:

These are not all the possible side effects you may have when taking MINT-METFORMIN XR. Taking MINT-METFORMIN XR with meals can help to reduce these side effects. If you experience any side effects not listed here, tell your healthcare professional.

diarrhea
nausea and vomiting
upset stomach

If you think you, or a person you are caring for, have taken too much MINT-METFORMIN XR, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

abdominal pain
abdominal bloating
gas
loss of appetite
weight loss
skin problems; skin reaction, rash, itchy skin

MINT-METFORMIN XR can cause abnormal blood test results. Your healthcare professional will do blood tests during your treatment.

Serious side effects and what to do about them

Frequency/ Side Effect /Symptom	Talk to your healthcare professional		Stop taking this drug and get immediate medical help
Frequency/ Side Effect /Symptom	Talk to your healthcare professional		Stop taking this drug and get immediate medical help
			Only if severe	In all cases
			Only if severe	In all cases
Rare
Encephalopathy (disease of the brain that severely alters thinking): Possible neurological symptoms include: muscle weakness in one area, poor decision making or concentration, involuntary twitching, trembling, difficulty speaking or swallowing, seizures.				√
Hemolytic anemia (breakdown of red blood cells): symptoms may include fatigue, pale color, rapid heartbeat, shortness of breath, dark urine, chills, and backache.				√
Lactic Acidosis (high levels of acid in the blood): feeling very weak, tired or uncomfortable, unusual muscle pain, trouble breathing, unusual or unexpected stomach discomfort, stomach pain with nausea and vomiting, or diarrhea, feeling cold, feeling dizzy or lightheaded, suddenly developing a slow or irregular heartbeat.				√
Pancreatitis (inflammation of the pancreas): prolonged severe abdominal pain which may be accompanied by vomiting; pain may spread out towards the back.				√
Peripheral neuropathy (a result of damage to your peripheral nerves): signs and symptoms might include gradual onset of numbness, prickling or tingling in your feet or hands, which can spread upward into your				√
legs and arms, sharp, jabbing, throbbing, freezing or burning pain, extreme sensitivity to touch, lack of coordination and falling, muscle weakness or paralysis if motor nerves are affected.
Very Rare
Liver problems: yellowing of your skin and eyes (jaundice), right upper stomach area pain or swelling, nausea or vomiting, unusual dark urine, unusual tiredness		√
Worsening of Mitochondrial Disease (a disease affecting energy producing components within cells): seizure, reduction in a person’s mental abilities (memory lapses, difficulty concentrating, trouble finding words or following conversations, poor judgment or decision-making confusion), difficulty with body movements, muscle pain or weakness, pain, numbness, migraine, deafness				√
Unknown
Hypothyroidism (underactive/low thyroid): Weight gain, tiredness, hair loss, muscle weakness, feeling cold, dry skin, constipation, puffy face, heavier than normal or irregular menstrual periods, enlarged thyroid gland		√
Photosensitivity (sensitivity to sunlight): itchy, red skin when exposed to sunlight		√

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Storage:

Store at 15˚C - 30˚C.
Keep out of reach and sight of children.
Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

If you want more information about MINT-METFORMIN XR:

Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (Drug Product Database: Access the database); the manufacturer’s website www.mintpharma.com or by calling 1-877-398-9696.

Last Revised: October 23, 2026

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

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.

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