Apo-Gliclazide: Uses, Side Effects and Dosage

What is APO-GLICLAZIDE used for?

APO-GLICLAZIDE is used along with diet and exercise to lower blood sugar levels in adults with type 2 diabetes.

How does APO-GLICLAZIDE work?

APO-GLICLAZIDE belongs to a group of medicines called hypoglycemic (antidiabetic) drugs. They are part of a subgroup of medicines called sulfonylureas. It helps improve the release of insulin in the body.

What are the ingredients in APO-GLICLAZIDE?

Medicinal ingredient: Gliclazide.

Non-medicinal ingredients: Colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose.

APO-GLICLAZIDE comes in the following dosage form:

Tablets; 80 mg

Do not use APO-GLICLAZIDE if:

• you are allergic to gliclazide, other sulfonylureas, sulfonamides, or to any of the other ingredients in APO-GLICLAZIDE
• you have unstable and/or insulin dependent type 1 diabetes (particularly juvenile diabetes)
• you have diabetic ketoacidosis (DKA)
• you have diabetic pre-coma and coma
• you have a serious infection, trauma or surgery
• you have severe liver problems
• you have severe kidney problems
• you are taking medicine containing miconazole (used to treat fungal or yeast infections)

• you are pregnant

• you are breast-feeding

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

• have or have had liver problems
• have or have had kidney problems
• are pregnant or planning to become pregnant
• are breast-feeding or planning to breast-feed
• have a blood disease called G6PD-deficiency anemia (a condition where red blood cells break down faster than they are made)
• have porphyria (a condition that results in chemicals building up in your body that results in symptoms affecting your skin, nervous system and other areas)
• are lactose intolerant (APO-GLICLAZIDE contains lactose)

Other warnings you should know about:

• Effect on Blood Sugar Levels

  • Low blood sugar levels (hypoglycemia):

    • APO-GLICLAZIDE may cause low blood sugar levels (a condition called hypoglycemia). You should talk to your healthcare professional about symptoms of low blood sugar levels and what to do if you have these symptoms. You should also test your blood sugar levels as instructed by your healthcare professional.

    • See the Serious side effects and what to do about them table for symptoms of low blood sugar levels (hypoglycemia).

      • If you experience these symptoms:

        • Immediately eat or drink something containing sugar. Good sources of sugar are:

          • orange juice
          • corn syrup
          • honey
          • sugar cubes or table sugar (dissolved in water)
        • Talk to your healthcare professional as soon as you can.

  • High blood sugar levels (hyperglycemia):

    • Your blood sugar may get too high (a condition called hyperglycemia) if you
    • In such cases, contact your healthcare professional as your medication may need to be adjusted.
    • Symptoms of high blood sugar levels include the following: thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.

• Serious Skin Reactions: (for example DRESS, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, bullous pemphigoid, hypersensitivity Syndrome) that can be any combination of red itchy rash with blisters and peeling of the skin and/or of the lips, eyes, mouth, nasal passages or genitals.

  • You may also have a fever, chills, headache, cough, body aches or joint pain.
  • You may have less or dark urine, yellow skin or eyes.
  • If you have these symptoms, you should stop taking APO-GLICLAZIDE immediately and talk to your healthcare professional.

• Children and adolescents (under 18 years of age):

  APO-GLICLAZIDE is not recommended for use in patients under 18 years of age.

• Driving and Operating Machinery:

  Your alertness and reactions may be impaired due to low blood sugar levels, especially when starting to take APO-GLICLAZIDE. This may affect your ability to drive or to operate machines.

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

The following may also interact with APO-GLICLAZIDE:

• medicines used to treat diabetes, known as antidiabetic agents (such as insulins, acarbose and biguanides);

• medicines used to treat bacterial infections, known as antibiotics (such as sulfonamides, clarithromycin and fluoroquinolones);

  • If APO-GLICLAZIDE is taken at the same time as fluoroquinolones, low and high blood sugar can occur.

  • Talk to your healthcare professional about monitoring your blood sugar levels if
• medicines used to treat tuberculosis, known as tuberculostatics;
• medicines used to treat fungal infections, known as anti-fungals (such as fluconazole);
• medicines used to treat inflammation, known as non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids (such as phenylbutazone);
• Medicines used to treat pain, fever, and inflammation, known as salicylates (such as acetylsalicylic acid);

• medicines used to treat high blood pressure and certain heart conditions, known as:

  • angiotensin converting enzyme (ACE) inhibitors;
  • beta blockers;
  • diuretics (such as thiazides and furosemide).
• medicines used to prevent blood clots, known as anticoagulants (such as warfarin);
• medicines used to treat high levels of cholesterol in the blood (such as fibrates and nicotinic acid);
• medicines used to treat acid reflux and heartburn, known as H2-receptor antagonists;
• medicines used to treat depression, known as monoamine oxidase inhibitors (MAOIs);
• chlorpromazine (used to treat certain psychiatric conditions);
• probenecid (used to treat high levels of uric acid in the blood and gout);
• salbutamol and terbutaline (used to treat asthma);
• ritodrine (used to stop premature labor);
• medicines used to treat seizures, known as sedatives and anti-seizure medications (such as barbiturates);
• medicines used for birth control, known as oral contraceptives (such as estrogen plus progestogen);
• danazol (used to treat breast cysts and endometriosis, a condition where tissue similar to the lining of the uterus grows outside the uterus);

• St. John’s Wort, an herbal compound commonly used to treat depression and mood disorders;

  • Using St. John’s Wort with APO-GLICLAZIDE may lead to high blood sugar levels and loss of blood sugar control.

• alcohol;

  • Avoid drinking alcohol and taking medicines containing alcohol while you are taking APO-GLICLAZIDE. This can lead to a drop in blood sugar levels.

Medicines like diuretics, corticosteroids, oral contraceptives, chlorpromazine, ritodrine, salbutamol, terbutaline, danazol and nicotinic acid may lead to high blood sugar levels. See Other warnings you should know about for more information on high blood sugar levels (hyperglycemia).

How to take APO-GLICLAZIDE:

• Take APO-GLICLAZIDE exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
• Take APO-GLICLAZIDE with meals at the same time each day.

Usual dose:

Your healthcare professional will decide how much APO-GLICLAZIDE you need to take. The usual starting dose is 1 tablet twice a day with meals. Depending on your response to APO-GLICLAZIDE, your healthcare professional may change your dose.

The daily dose should not exceed 320 mg (4 tablets).

Talk to your healthcare professional about checking your blood sugar levels. You should test your blood sugar levels as instructed by your healthcare professional to make sure that your blood sugar levels are being controlled.

Overdose:

Missed dose:

If you miss a dose of this medicine, skip the missed dose. Take your next dose at the regular time the next day. Do not double dose.

What are possible side effects from using APO-GLICLAZIDE?

These are not all the possible side effects you may have when taking APO-GLICLAZIDE. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• low blood sugar (hypoglycemia)
• high blood sugar (hyperglycemia)
• viral infection
• infection of the nose, sinuses, or throat (upper respiratory infection)
• runny nose
• sore throat
• cough
• back, muscle and joint pain
• headache
• high blood pressure (hypertension)
• chest pain (angina)
• leg swelling
• diarrhea
• constipation
• abdominal pain
• nausea
• dizziness
• skin rash
• itching
• depression
• urinary tract infection
• pink eye (conjunctivitis)

Serious side effects and what to do about them

Serious side effects and what to do about them

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

Storage:

• Store APO-GLICLAZIDE at room temperature (15°C to 30°C).
• Keep out of reach and sight of children and pets.

If you want more information about APO-GLICLAZIDE:

• 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: (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.

Last Revised: FEB 28, 2025