Consumer Information for: MYLAN-GLICLAZIDE MR

Mylan-Gliclazide MR is used along with diet and exercise to lower blood sugar levels in adults with type 2 diabetes.

Mylan-Gliclazide MR 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.

Medicinal ingredients: Gliclazide.

Non-medicinal ingredients:

Mylan-Gliclazide MR 30 mg and 60 mg tablets contain: Hypromellose, magnesium stearate and microcrystalline cellulose.

• 30 mg modified-release tablets

• 60 mg modified-release breakable tablets

• 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 (this is 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)

• Effect on Blood Sugar Levels

  • Low blood sugar levels (hypoglycemia):

    • Mylan-Gliclazide MR 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 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 experience a fever, infection, surgery, or trauma (stressful conditions).

    • 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 Mylan-Gliclazide MR immediately and talk to your healthcare professional.

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

Mylan-Gliclazide MR 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 Mylan-Gliclazide MR. 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.

• medicines that are used to treat diabetes such as other antidiabetic agents

• medicines used to treat bacterial infections (antibiotics) such as sulfonamides/sulfa drugs, clarithromycin and fluoroquinolones.

  • If Mylan-Gliclazide MR 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 taking these medicines together. This is especially important if you are elderly.

• medicines used to treat tuberculosis (anti-tuberculosis)

• medicines used to treat fungal infections (anti-fungal) such as fluconazole.

• medicines used to treat inflammation (non-steroidal anti-inflammatory drugs (NSAIDs)) such as phenylbutazone or corticosteroids.

• salicylates (used to treat pain, fever and inflammation) such as acetylsalicylic acid.

• medicines used to treat high blood pressure and certain heart conditions like:

  • angiotensin converting enzyme (ACE) inhibitors,

  • beta blockers

  • diuretics such as thiazides and furosemide

• medicines used to thin blood (anticoagulant therapy) such as warfarin

• medicines used to treat high levels of fats in the blood such as fibrates and nicotinic acid

• 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)

• medicines used to treat asthma such as salbutamol and terbutaline

• ritodrine (used to stop premature labor)

• medicines used to treat seizures (barbiturates) such as sedatives and anti-seizure medications.

• oral contraceptives used for birth control 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, a herbal product used to treat depression

  • Using St. John’s Wort with Mylan-Gliclazide MR 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 Mylan-Gliclazide MR. 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 for more information on high blood sugar levels (hyperglycemia).

• Take Mylan-Gliclazide MR exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.

• Take Mylan-Gliclazide MR once daily at breakfast.

• The 30 mg tablets cannot be split in half. Swallow the tablet whole with water.

• The 60 mg tablets can be halved.

• Do not crush or chew the tablets of either strength.

30 mg per day. This is one tablet of Mylan-Gliclazide MR 30 mg or half tablet of Mylan-Gliclazide MR 60 mg.

The daily dose should not exceed 120 mg.

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.

Your healthcare professional will check your blood sugar levels during regular visits, especially when you start taking this medicine.

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.

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

• 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)

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.

• Keep out of reach and sight of children and pets.

• Mylan-Gliclazide MR should be stored at room temperature between (15°C to 30°C).

• 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.

• 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 www.mylan.ca or by calling 1-844-596-9526.

This leaflet was prepared by Mylan Pharmaceuticals ULC.

Last Revised: MAR 08, 2024