Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
GLICLAZIDE
Les Laboratoires Servier
GLICLAZIDE
30 Milligram
Modified-release Tablets
Product subject to prescription which may be renewed (B)
Withdrawn
2013-11-04
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glydium MR 30mg, modified release tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains gliclazide 30 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified release tablet. White, oblong tablet engraved on both faces, ‘DIA 30’ on one face and on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Non insulin-dependent diabetes (type 2) in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The daily dose may vary from 1 to 4 tablets per day, _i.e_. from 30 to 120 mg taken orally in a single intake at breakfast time. It is recommended that the tablet(s) be swallowed whole. If a dose is forgotten, there must be no increase in the dose taken the next day. As with any hypoglycaemic agent, the dose should be adjusted according to the individual patient's metabolic response (blood glucose, HbAlc) • Initial dose The recommended starting dose is 30 mg daily. If blood glucose is effectively controlled, this dose may be used for maintenance treatment. If blood glucose is not adequately controlled, the dose may be increased to 60, 90 or 120 mg daily, in successive steps. The interval between each dose increment should be at least 1 month except in patients whose blood glucose has not reduced after two weeks of treatment. In such cases, the dose may be increased at the end of the second week of treatment. The maximum recommended daily dose is 120 mg. • Switching from Diamicron 80 mg tablets to GLYDIUM MR 30 mg modified release tablets: 1 tablet of Diamicron 80 mg is comparable to 1 tablet of GLYDIUM MR 30 mg. Consequently the switch Read the complete document