Glucozid MR Tablet: The daily dose of Gliclazide MR (Glucozid MR) may vary from 30 to 120 mg once daily (i.e. 1 to 4 tablets of Glucozid MR 30 or ½ to 2 tablets of Glucozid MR 60). The recommended starting dose is 30 mg daily, i.e. 1 tablet of Glucozid MR 30 or ½ tablet of Glucozid MR 60), even in elderly patients over 65 years. The daily dose should not exceed 120 mg. Patients with renal or hepatic impairment should be started with Glucozid MR 30 with dosage adjustments being made cautiously.

Gliclazide is contraindicated in patients with known hypersensitivity or allergy to Gliclazide, other sulfonylureas, sulfonamides or any of the excipients of this product. It is also contraindicated in Type 1 diabetes mellitus, particularly juvenile diabetes, diabetic ketoacidosis, diabetic pre-coma & coma, serious infection, trauma or surgery, severe hepatic & renal impairment, treatment with miconazole via systemic route or oromucosal gel, pregnancy & lactation.

Care should be exercised in patients with hepatic and renal impairment and a small starting dose should be used with careful patient monitoring. The use of Gliclazide must be considered as treatment in addition to the proper dietary regimen and not as a substitute for diet. Since the effects of oral hypoglycemic agents on the vascular changes and long-term sequelae of diabetes mellitus are not fully known, patients receiving such drugs must be closely observed for both short and long-term complications. Periodic assessment of cardiovascular, ophthalmic, renal, and hepatic status is advisable. Gliclazide use is not recommended with medications containing alcohol, phenylbutazone (systemic route), and danazol and precautions are required when used with chlorpromazine, glucocorticoids, ritodrine, salbutamol, terbutaline, and anticoagulant therapy.

Hypoglycemia may occur in concurrent conditions such as hepatic & renal diseases, alcohol intoxication, adrenal & pituitary insufficiency. Gastrointestinal disturbances including nausea, epigastric fullness & heart burn are most common but dose-related and may disappear when the dose is reduced. Allergic skin reactions including rash, pruritus, erythema & urticaria have been reported. These may be transient and may disappear despite continued use of the drug. If skin reactions persist, discontinue the drug.

Sulfonamides, tuberculostatic, NSAIDs, fibrates, MAO inhibitors, salicylates, probenecid, beta-blockers, H2 receptor antagonist, ACE inhibitors, clarithromycin may enhance the hypoglycemic effect of Gliclazide. Certain diuretics (thiazides, furosemide), corticosteroids, oral contraceptives (estrogen plus progestogen), chlorpromazine, ritodrine and salbutamol may decrease the hypoglycemic effect of Gliclazide. Barbiturates should be used with caution in patients receiving an oral hypoglycemic agent since they may reduce the hypoglycemic effect. Sulfonylureas may potentiate the action of anticoagulants. Adjustment of the anticoagulant dose may be necessary.

Pregnancy: Gliclazide is contraindicated in pregnancy. Nursing mothers: Gliclazide should not be used during breast-feeding. Pediatrics (<18 years of age): Safety and effectiveness of in children have not been established. Therefore, Gliclazide is not recommended for use in children and adolescents. Geriatrics (≥ 65 years of age): No clinically significant modifications in the pharmacokinetic parameters have been observed in elderly patients. Hepatic impairment: Gliclazide is contraindicated in patients with severe hepatic impairment. Renal impairment: The metabolism and excretion of sulfonylureas including Gliclazide may be slowed in patients with impaired renal function. Therefore, Gliclazide is contraindicated in patients with severe renal impairment.

Glucozid MR 30 Tablet: Each box contains 30 tablets in Alu-PVDC blister pack.
Glucozid MR 60 Tablet: Each box contains 30 tablets in Alu-PVDC blister pack.