Diamicron 30mg MR tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Gliclazide

Tilgjengelig fra:

Mawdsley-Brooks & Company Ltd

ATC-kode:

A10BB09

INN (International Name):

Gliclazide

Dosering :

30mg

Legemiddelform:

Modified-release tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 06010201

Informasjon til brukeren

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Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Diamicron 30mg MR Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One 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
Posology
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 Diamicron 30 mg modified
release tablets:
1 tablet of Diamicron 80 mg is comparable to 1 tablet of Diamicron 30
mg MR
Tablets.
Consequently
the
switch
can
be
performed
provided
a
careful
blood
monitoring.
•
Switching from another oral antidiabetic agent to Diamicron 30 mg MR
Tablets:
Diamicron 30 mg MR Tablets can be used to replace other oral
antidiabetic agents.
The dosage and the half-life of the previous