GLYDIUM 30 Milligram Modified-release Tablets
Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Lastnosti izdelka
(SPC)
02-05-2024
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Aktivna sestavina:
GLICLAZIDE
Dostopno od:
Les Laboratoires Servier
INN (mednarodno ime):
GLICLAZIDE
Odmerek:
30 Milligram
Farmacevtska oblika:
Modified-release Tablets
Tip zastaranja:
Product subject to prescription which may be renewed (B)
Status dovoljenje:
Withdrawn
Datum dovoljenje:
2013-11-04
Lastnosti izdelka
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
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