DIADEON MR 60 MG MODIFIED RELEASE TABLETS
Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Karakteristik produk
(SPC)
03-05-2024
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Bahan aktif:
GLICLAZIDE
Tersedia dari:
Les Laboratoires Servier
Dosis:
60 Milligram
Bentuk farmasi:
Modified-release Tablets
Tanggal Otorisasi:
2009-12-18
Karakteristik produk
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: lactose
For a 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 halves.
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
Oral use.
For adult use only.
The daily dose of Diadeon MR 60mg 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 Diadeon MR 60mg). 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 60 mg
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