GLYDIUM 60 Milligram Modified-release Tablets
Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Produktets egenskaber
(SPC)
27-04-2024
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Aktiv bestanddel:
GLICLAZIDE
Tilgængelig fra:
Les Laboratoires Servier
INN (International Name):
GLICLAZIDE
Dosering:
60 Milligram
Lægemiddelform:
Modified-release Tablets
Recept type:
Product subject to prescription which may be renewed (B)
Autorisation status:
Withdrawn
Autorisation dato:
2013-11-04
Produktets egenskaber
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glydium MR 60mg, modified release tablet
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 GLYDIUM 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).
•
Initial dose
The recommended starting dose is 30 mg daily (half a tablet of GLYDIUM 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 GLYDIUM MR 60 m
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