Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
GLICLAZIDE
Les Laboratoires Servier
GLICLAZIDE
60 Milligram
Modified-release Tablets
Product subject to prescription which may be renewed (B)
Withdrawn
2012-12-18
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diadeon MR 60 mg modified release tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One modified release tablet contains gliclazide 60 mg Excipients with known effect: lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified release tablet. White, oblong, tablet, scored and engraved, with ‘DIA 60’ on both faces The tablet can be divided into equal doses. 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 of DIADEON MR 60 mg may vary from one half to 2 tablets per day, _i.e_. from 30 to 120 mg taken orally in a single intake at breakfast time. It is recommended to swallow the dose without crushing or chewing. 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). o Initial dose The recommended starting dose is 30 mg daily (half a tablet of DIADEON MR 60 mg). 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. One DIADEON MR 6 Baca dokumen lengkap