Summary of content

Gliclazide

Visa No.: 893110379023

Product: Pyme Diapro MR

API: Gliclazid

Product Category: Cardiovascular & Metabolism

Version approved leaflet: 263/QĐ-QLD_26/05/ 2015_150

 

INDICATIONS

Treatment of non–insulin-dependent type II diabetes mellitus, as an adjunct to an appropriate diet, when adequate glycemic control cannot be achieved by diet alone.

DOSAGE AND ADMINISTRATION

Adults:
•    The daily dose may range from 1 to 4 tablets per day, taken once daily with breakfast. Recommended starting dose: 1 tablet (30 mg/day).
•    If satisfactory glycemic control is achieved, the dose may be increased to: 2 tablets (60 mg/day), 3 tablets (90 mg/day), or 4 tablets (120 mg/day).
•    Dose adjustments should be made stepwise, with each increase separated by at least 1 month, except in patients whose blood glucose levels do not decrease after 2 weeks of treatment.
•    Maximum recommended dose: 120 mg/day.
 

CONTRAINDICATIONS

Gliclazide is contraindicated in the following cases:
•    Hypersensitivity to gliclazide, other sulfonylureas, or sulfonamides.
•    Type I diabetes mellitus, particularly: diabetes in children
•    metabolic acidosis,  severe ketoacidosis, diabetic coma or pre-coma.
•    Severe hepatic or renal impairment.
•    Concomitant use with oral miconazole.
•    Pregnancy and breastfeeding.
•    Severe infections, major trauma, or major surgery.
 

WARNINGS AND PRECAUTIONS

Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children.