Apo-Gliclazide MR

Gliclazide.

Each modified-release breakable tablet contains 60 mg gliclazide.
Excipients/Inactive Ingredients: APO-GLICLAZIDE MR 60 mg tablets contain: lactose, colloidal silicon dioxide, hypromellose and stearic acid.

APO-GLICLAZIDE MR belongs to the family of hypoglycemic (antidiabetic) drugs and part of a subfamily of medicines called sulfonylureas. It helps improve insulin secretion in the body.

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.

Usual Dose: The recommended starting dose of APO-GLICLAZIDE MR is 30 mg per day (a half tablet of APO-GLICLAZIDE MR 60 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 60 mg tablets can be halved. Do not crush or chew the tablet.
Test the sugar level as directed by the physician to make sure that the blood sugar is being controlled. The physician should check the progress at regular visits, especially during the first few weeks of taking this medicine.
Missed Dose: If a dose of this medicine is missed, skip the missed dose. Take the next dose at the regular time. Do not double doses.

Taking too much of any medicine can be dangerous. If too many APO-GLICLAZIDE MR tablets are taken at once, call the doctor or the nearest poison control center, or go to the emergency room of the local hospital.

APO-GLICLAZIDE MR is contraindicated (must not be taken): if allergic or hypersensitive to gliclazide, other sulfonylureas, sulfonamides, or to any of the ingredients of these products; if with unstable and/or insulin-dependent diabetes mellitus, juvenile diabetes (type I diabetes), diabetic ketoacidosis, diabetes pre-coma and coma; if with a serious infection, trauma or surgery; if with severe liver problems; if with severe kidney problems; if receiving treatment with miconazole; if pregnant and/or breast-feeding.

APO-GLICLAZIDE MR may cause low blood sugar (hypoglycemia). Ask the doctor, pharmacist or diabetes educator about symptoms of low blood sugar and what to do if these symptoms are experienced. Test the blood sugar as instructed by the doctor.
BEFORE using APO-GLICLAZIDE MR, talk to the doctor or pharmacist if: with existing or history of liver problems; with existing or history of kidney problems; pregnant or planning to get pregnant; breast-feeding; with a blood disease called G6PD-deficiency anemia; with an intolerance to lactose.
Blood sugar may get too high (hyperglycemia) if experiencing fever, infection, surgery or trauma (stress conditions). In such cases, contact the doctor as the medication may need to be adjusted.
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 the ability to drive or to operate machinery.
Use in Children: APO-GLICLAZIDE MR is not recommended for use in children under 18 years of age.

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 APO-GLICLAZIDE MR: 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.
The usual signs of low blood sugar level (hypoglycemia) are: anxious feeling, drowsiness, dizziness, chills, cold sweats, confusion, cool pale skin, difficulty in concentration, excessive hunger, fast heartbeat, headache, nausea, depression, nervousness, shakiness, unsteady walk, unusual tiredness or weakness. The following signs and symptoms may also occur: clammy skin, anxiety, irregular heartbeat, high blood pressure, chest pain or pressure, and/or shortness of breath (angina pectoris).
If some of these signs of drop in blood sugar are recognized, immediately eat or drink something containing sugar and notify the doctor without delay. Good sources of sugar are: orange juice, corn syrup, honey, or sugar cubes or table sugar (dissolved in water).
Serious side effects, how often they happen, and what to do about them: See table.

Click on icon to see table/diagram/image

Serious Drug Interactions: APO-GLICLAZIDE MR (gliclazide) should not be taken if miconazole (an anti-fungal drug) is also being taken (see Contraindications).
Other drugs that may interact with APO-GLICLAZIDE MR: other antidiabetic agents; antibiotics (sulfonamides/sulfa drugs, clarithromycin); 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 previously described may lead to loss of blood sugar control (high blood sugar), including diuretics, corticosteroids, oral contraceptives, chlorpromazine, ritodrine, salbutamol, terbutaline, danazol and nicotinic acid.
Avoid drinking alcoholic beverages and taking medicines containing alcohol while taking APO-GLICLAZIDE MR as this can lead to a drop in blood sugar (hypoglycemia).
Tell the doctor if any of the medicines previously listed or any other medicines, including those obtained without a prescription, have recently been taken. Do not take other medicines unless prescribed or approved by the doctor. Tell any healthcare professionals that APO-GLICLAZIDE MR is being taken.

Medicines should not be disposed of down the drain or in household garbage. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

APO-GLICLAZIDE MR should be stored at room temperature 15-30°C (59-86°F). Protect from moisture.

Antidiabetic Agents

A10BB09 - gliclazide ; Belongs to the class of sulfonylureas. Used in the treatment of diabetes.

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