Patient Medication Information: uses, side effects, how to take - Apo-Metformin ER
Serious Warnings and Precautions
- APO-METFORMIN ER 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 APO-METFORMIN ER.
Stop taking APO-METFORMIN ER 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.
APO-METFORMIN ER 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 APO-METFORMIN ER 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 is APO-METFORMIN ER 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 mellitus. APO-METFORMIN ER can be used with other antidiabetic medicines or by itself.
How does APO-METFORMIN ER work?
APO-METFORMIN ER help 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 APO-METFORMIN ER continue to exercise and follow the diet advised by your doctor for your diabetes.
What are the ingredients in APO-METFORMIN ER?
Medicinal ingredients: metformin hydrochloride.
Non-medicinal ingredients APO-METFORMIN ER 500 mg: colloidal silicon dioxide, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, titanium dioxide.
Non-medicinal ingredients APO-METFORMIN ER 1000 mg: carbomer homopolymer Type A, carbomer homopolymer Type B, dibutyl sebacate, ethyl cellulose, hydroxypropyl methylcellulose, magnesium stearate.
APO-METFORMIN ER comes in the following dosage forms:
Extended-Release tablets, APO-METFORMIN ER 500 mg
Extended-Release tablets, APO-METFORMIN ER 1000 mg
Do not use APO-METFORMIN ER if you:
- have a known allergy to metformin, or any ingredients found in APO-METFORMIN ER tablets
- have Type 1 diabetes that is unstable and / or insulin dependent.
- have metabolic acidosis (including diabetic ketoacidosis or a history of ketoacidosis, with or without coma
- have a history of lactic acidosis (too much acid in the blood)
- have severe liver problems
- have heart system collapse (blood circulation failure) or heart problems that can cause hypoxemia (low oxygen in the blood)
- have kidney problems
- regularly drink alcohol
- are going to get injection of dyes (iodinated contrast materials)
- are stressed, have a severe infection, or are experiencing trauma
- will have surgery and during recovery after your surgery
- have severe dehydration (have lost a lot of water from your body) or shock
- are pregnant or planning to become pregnant
- are breast feeding
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-METFORMIN ER. 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 metabolic acidosis (e.g. diabetic ketoacidosis)
- have had a recent heart attack
- have had recent stroke
- have a serious infection
- are dehydrated
- are scheduled for surgery
- are scheduled for 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
Other warnings you should know about:
Vitamin B12 levels:
- APO-METFORMIN ER can cause your vitamin B12 levels to be low. This can cause peripheral neuropathy (nerve damage).
Thyroid problems:
APO-METFORMIN ER 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.
See the “Serious side effects and what to do about them” table, below, for more information on these and other serious side effects.
Low Blood Sugar:
- APO-METFORMIN ER 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 APO-METFORMIN ER.
Patients older than 65 years old:
- You should not take APO-METFORMIN ER 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 APO-METFORMIN ER 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 APO-METFORMIN ER.
- Do not breastfeed while you are taking APO-METFORMIN ER.
Driving and using machines: Do not drive or operate machines if you develop hypoglycemia (low blood sugar levels).
If any of the above side effects occur, contact your healthcare professional immediately.
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 APO-METFORMIN ER:
- 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 APO-METFORMIN ER:
- 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:
If you think you, or a person you are caring for, have taken too much APO-METFORMIN ER, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
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 APO-METFORMIN ER
- 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.
What are possible side effects from using APO-METFORMIN ER?
These are not all the possible side effects you may have when taking APO-METFORMIN ER. Taking APO-METFORMIN ER 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 vomitting
- upset stomach
- abdominal pain
- abdominal bloating
- gas
- loss of appetite
- weight loss
- skin problems; skin reaction, rash, itchy skin
APO-METFORMIN ER 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
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Serious side effects and what to do about them | |||
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| 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): Symptoms include: that can cause death, feeling very weak, tiered 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 | √ | ||
| 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.
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.
Storage:
- Store at 15°C to 30°C in tight, light resistant containers. Protect from moisture.
- Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
- Keep out of reach and sight of children.
If you want more information about APO-METFORMIN ER:
- 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 Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.