Details for: APO-GLICLAZIDE MR
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02297795 | APO-GLICLAZIDE MR | GLICLAZIDE | 30 MG | TABLET (EXTENDED-RELEASE) | ORAL |
| 02407124 | APO-GLICLAZIDE MR | GLICLAZIDE | 60 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-GLICLAZIDE MR is used to lower blood glucose level in adult patients with type 2 diabetes mellitus in addition to proper diet, exercise and weight reduction
What it does
APO-GLICLAZIDE MR belongs to the family of hypoglycemic (antidiabetic) drugs and part of a sub family of medicines called sulfonylureas. It helps improve insulin secretion in the body
When it should not be used
-
APO-GLICLAZIDE MR is contraindicated (must not be taken) if
you:
- are allergic or hypersensitive to gliclazide, other sulfonylureas, sulfonamides, or to any of the ingredients of these products,
- have unstable and/or insulin-dependent diabetes mellitus, juvenile diabetes (type I diabetes), diabetic ketoacidosis, diabetes pre-coma and coma,
- have a serious infection, trauma or surgery,
- have severe liver problems,
- have severe kidney problems,
- receive treatment with miconazole,
- are pregnant and/or breast-feeding.
What the medicinal ingredient is
Gliclazide.
What the non-medicinal ingredients are
APO-GLICLAZIDE MR 30 mg tablets contain: colloidal silicon dioxide, hydroxypropyl methylcellulose and stearic acid.
APO-GLICLAZIDE MR 60 mg tablets contain: colloidal silicon dioxide, hypromellose, lactose and stearic acid
What dosage form it comes in
APO-GLICLAZIDE MR comes in modified-release tablets of 30 mg and modified release breakable tablets of 60 mg.
Warnings and precautions
Serious Warnings and Precautions
APO-GLICLAZIDE MR may cause low blood sugar (hypoglycemia). You should ask your doctor, pharmacist or diabetes educator about symptoms of low blood sugar and what to do if you experience these symptoms. You should also test your blood sugar as instructed by your doctor.
-
BEFORE you use APO-GLICLAZIDE MR talk to your
doctor or pharmacist if you:
- have or have had liver problems,
- have or have had kidney problems,
- are pregnant or planning to get pregnant,
- are breast-feeding,
- have a blood disease called G6PD-deficiency anemia,
- have porphyria (genetic disease in which your body builds-up chemicals with skin, nervous system or other symptoms)
- have an intolerance to lactose (for APO-GLICLAZIDE MR 60 mg).
Your blood sugar may get too high (hyperglycaemia) if you take Saint John's Wort preparations or if you experience fever, infection, surgery or trauma (stress conditions). In such cases, contact your doctor as your medication may need to be adjusted. Serious Skin Reactions (DRESS, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, bullous pemphigoid, hypersensitivity Syndrome): any combination of red itchy rash with blisters and peeling of the skin and /or of the lips, eyes, mouth, nasal passages or genitals. It often goes with fever, chills, headache, cough, body aches or joint pain. You may have less or dark urine, yellow skin or eyes. If you suspect these, you should stop taking the drug and talk with your doctor or pharmacist.
Low blood sugar and high blood sugar can occur when APOGLICLAZIDE MR is prescribed at the same time as medicines belonging to a class of antibiotics called fluoroquinolones, especially if you are elderly. If you are taking these medications together, your doctor will remind you of the importance of monitoring your blood glucose.
APO-GLICLAZIDE MR is not recommended for use in children under 18 years of age. Driving and Operating Machinery: Alertness and reactions may be impaired due to low blood sugar (hypoglycemia), especially at beginning of the treatment. This may affect your ability to drive or to operate machinery.
Interactions with this medication
APO-GLICLAZIDE MR (gliclazide) should not be taken if you are also taking miconazole (an anti-fungal drug). See “When it should not be used” section of this leaflet
-
Other drugs that may interact with APO-GLICLAZIDE MR
include:
- other antidiabetic agents
- antibiotics (sulphonamides/sulfa drugs, clarithromycin, fluoroquinolones)
- anti-tuberculosis drugs
- anti-fungal drugs (fluconazole)
- non-steroidal anti-inflammatory drugs (NSAIDs) including phenylbutazone (used to treat inflammation and pain)
- corticosteroids (used to treat inflammation)
- salicylates (e.g. acetylsalicylic acid)
- angiotensin converting enzyme (ACE) inhibitors (used to treat high blood pressure and certain heart conditions)
- beta blockers (used to treat high blood pressure and certain heart conditions)
- anticoagulant therapy (blood thinners), including warfarin
- diuretics (thiazides, furosemide) (used to treat high blood pressure and certain heart conditions)
- fibrates, nicotinic acid (used to treat high levels of fats in the blood)
- H2-receptor antagonists (used to treat acid reflux/heartburn)
- monoamine oxidase inhibitors (used to treat depression)
- chlorpromazine (used to treat certain psychiatric conditions)
- probenecid (used to treat high levels of uric acid in the blood and gout)
- salbutamol, terbutaline (used to treat asthma) and ritodrine
- barbiturates (sedatives, anti-seizure medications)
- oral contraceptives (estrogen plus progestogen, used for birth control)
- danazol (used to treat breast cysts and endometriosis)
- alcohol.
Some of the drugs described above may lead to loss of blood sugar control (high blood sugar), including diuretics, corticosteroids, oral contraceptives, chlorpromazine, ritodrine, salbutamol, terbutaline, danazol and nicotinic acid.
Some herbs such as Saint John's Wort preparations may lead to high blood sugar and loss of blood sugar control. Avoid drinking alcoholic beverages and taking medicines containing alcohol while you are taking APO-GLICLAZIDE MR as this can lead to a drop in blood sugar (hypoglycaemia).
Tell your doctor if you have recently taken any of the medicines listed above or any other medicines, including those obtained without a prescription. Do not take other medicines unless prescribed or approved by your doctor. Tell any health care professionals that you see that you are taking APOGLICLAZIDE MR.
Proper use of this medication
Usual Dose
The recommended starting dose of APO-GLICLAZIDE MR is 30 mg per day (a half tablet of APO-GLICLAZIDE MR 60 mg or a tablet of APO-GLICLAZIDE MR 30 mg), even in elderly patients (over 65 years old). The daily dose should not exceed 120 mg.
Take APO-GLICLAZIDE MR once daily at breakfast. The 30 mg tablets cannot be split in half and should be swallowed whole with a glass of water. The 60 mg tablets can be halved. Do not crush or chew the tablets of either strength.
You should test your sugar level as directed by your physician to make sure that your blood sugar is being controlled. Your physician should check your progress at regular visits, especially during the first few weeks that you take this medicine.
Overdose
Taking too much of any medicine can be dangerous. If you take too many APO-GLICLAZIDE MR tablets at once, call your doctor or your nearest poison control center, or go to the emergency room of your local hospital.
Missed Dose
If you miss a dose of this medicine, skip the missed dose. Take your next dose at the regular time. Do not double doses.
Side effects and what to do about them
APO-GLICLAZIDE MR is associated with some side effects. It may, however, affect different people in different ways. Common side effects reported during clinical trials with APOGLICLAZIDE MR included:
- hypoglycemia (low blood sugar)
- hyperglycemia (high blood sugar)
- viral infection
- upper respiratory infection, runny nose, sore throat, cough
- back, muscle and joint pain
- headache
- high blood pressure
- angina (chest pain)
- leg swelling
- diarrhea, constipation, abdominal pain, nausea
- dizziness
- skin rash/itching
- depression
If you recognize some of these signs of the drop in blood sugar, immediately eat or drink something containing sugar and notify your doctor without delay. Good sources of sugar are: orange juice, corn syrup, honey, or sugar cubes or table sugar (dissolved in water).
| 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 |
|---|---|---|---|
| Common | |||
| Low blood sugar level (hypoglycemia) The usual signs are: | ✔ | ||
| Anxious feeling | ✔ | ||
| Drowsiness | ✔ | ||
| Chills | ✔ | ||
| Cold sweats | ✔ | ||
| Confusion | ✔ | ||
| Cool pale skin | ✔ | ||
| Difficulty in concentration | ✔ | ||
| Excessive hunger | ✔ | ||
| Fast heartbeat | ✔ | ||
| Headache | ✔ | ||
| Nausea | ✔ | ||
| Dizziness | ✔ | ||
| Nervousness | ✔ | ||
| Shakiness | ✔ | ||
| Unsteady walk | ✔ | ||
| Unusual tiredness or weakness | ✔ | ||
| Uncommon | |||
| Unexplained fever, chills or sore throat | ✔ | ||
| Yellowing of skin or eyes, dark- coloured urine or lightcoloured bowel movements (e.g. jaundice) | ✔ | ||
| Skin rash, redness, itching or hives | ✔ | ||
| Oedema, swelling of the legs or unexpected weight gain | ✔ | ||
| Chest pain or pressure, and/or shortness of breath | ✔ | ||
| Very Rare | |||
| Blood abnormalities with symptoms of sore throat, fever, mouth sore, unusual bleeding or bruising, low level of red blood cells (anemia) | ✔ | ||
| Allergic inflammation of blood vessels (vasculitis) | ✔ | ||
| Low sodium level in blood combined with symptoms of tiredness, weakness and confusion (hyponatraemia) | ✔ | ||
| Rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty (angioedema) | ✔ | ||
| Serious Skin Reactions (DRESS, StevensJohnson Syndrome, Toxic Epidermal Necrolysis, bullous pemphigoid, hypersensitivity Syndrome): any combination of red itchy rash with blisters and peeling of the skin and /or of the lips, eyes, mouth, nasal passages or genitals. It often goes with fever, chills, headache, cough, body aches or joint pain. You may have less or dark urine, yellow skin or eyes | ✔ | ||
How to store
Keep out of reach or sight of children and pets. APO-GLICLAZIDE MR 30 mg tablets: Store- at room temperature 15 oC to 25 oC. Protect from humidity.
APO-GLICLAZIDE MR 60 mg tablets: Store- at room temperature 15 C to 30°C. Protect from moisture. Medicines should not be disposed of down the drain or in household garbage. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at MedEffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701D
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available at MedEffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
- Talk to your doctor or pharmacist.
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website ***
Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/indexeng.jsp). Find the Consumer Information on the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708