Diamicron MR 30 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Gliclazide

Available from:

Imbat Limited

ATC code:

A10BB; A10BB09

INN (International Name):

Gliclazide

Dosage:

30 milligram(s)

Pharmaceutical form:

Modified-release tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Sulfonamides, urea derivatives; gliclazide

Authorization status:

Authorised

Authorization date:

2008-01-18

Summary of Product characteristics

Health Products Regulatory Authority
12 November 2019
CRN009G31
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diamicron MR 30 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30mg gliclazide as the active ingredient.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified release tablet.
_Product imported from Spain and the Czech Republic._
White, oblong tablet engraved on both faces, 'DIA 30' on one face and
the servier logo 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
Oral use.
For adult use only.
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 MR 30 mg modified
release tablets:
1 tablet of Diamicron 80 mg is comparable to 1 tablet of Diamicron MR
30 mg. Consequently the switch can be performed
provided a careful blood monitoring.
Switching from another oral antidi