Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET
**Dosage and method of administration** For adults only. As with all hypoglycaemic agents, the dosage must be adapted to suit each individual case. In the case of transient disturbance of glucose control, administration of the product for a short period of time may be sufficient in a patient in whom the glucose balance is normally well maintained by dietary measures. **\*Subjects under the age of 65 years** Initial dose The recommended initial dose is 1 tablet per day. Dosage increments The dosage is usually adjusted in increments of 1 tablet depending on the glycemic response. Each dosage increment should be separated by at least 14 days. Maintenance treatment The dosage varies from 1 to 3 tablets per day, 4 in exceptional cases. The standard dosage is 2 tablets per day, taken as 2 daily doses. **\*High-risk subjects** Subjects over the age of 65 years - Begin the treatment with ½ tablet taken once a day. - This dosage may be progressively increased until satisfactory glucose control is obtained in the patient, provided that an interval of at least 14 days is maintained after each dosage increase and blood sugar levels are monitored closely. In other high-risk patients In patients who are undernourished or with a marked change in their general state or whose calorie intake is irregular, and in patients with renal or hepatic insufficiency, treatment must be initiated at the lowest dose and the guidelines for dosage increases scrupulously respected, so as to avoid any hypoglycaemic reactions (cf. Warnings and special precautions for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Patients receiving other oral hypoglycaemic agents As with all hypoglycaemic sulphonylureas, this drug may replace other anti-diabetic treatments without any transition period. On changing from a hypoglycaemic sulphonylurea with a longer half-life (e.g. chlorpropamide) to this drug, patients should be closely monitored (over several weeks) to avoid the occurrence of hypoglycaemia, due to the possibility of an overlap of the therapeutic effects.
ORAL
Medical Information
**Indications** Non-insulin-dependent diabetes, in association with an adapted diet, in cases where dietary measures alone provide inadequate control of blood glucose levels.
**Contra-indications** The use of this medicine is contra-indicated in the following cases: - hypersensitivity to gliclazide or other sulphonylureas or sulphonamides, or to any of the excipients used; - Type I diabetes, insulin-dependent diabetes, particularly juvenile diabetes; - diabetic precoma and coma; diabetic ketoacidosis; - severe hepatic or renal insufficiency: in these cases, the use of insulin is recommended; - treatment with miconazole (see Drug interactions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_); - pregnancy and lactation (see Pregnancy and Lactation – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). In general, it is not advisable to combine this drug with phenylbutazone, danazol (see Drug interactions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) or alcohol.
A10BB09
gliclazide
Manufacturer Information
SERVIER (S) PTE LTD
LES LABORATOIRES SERVIER INDUSTRIE
Active Ingredients
Documents
Package Inserts
Diamicron 80 PI.pdf
Approved: November 20, 2017