Diacronal MR 30 mg modified-release tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Gliclazide

Tilgjengelig fra:

KRKA, d.d., Novo mesto

ATC-kode:

A10BB; A10BB09

INN (International Name):

Gliclazide

Dosering :

30 milligram(s)

Legemiddelform:

Modified-release tablet

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Sulfonamides, urea derivatives; gliclazide

Autorisasjon status:

Marketed

Autorisasjon dato:

2008-07-04

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DIACRONAL MR 30 MG MODIFIED-RELEASE TABLETS
Gliclazide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Diacronal MR is and what it is used for
2.
What you need to know before you take Diacronal MR
3.
How to take Diacronal MR
4.
Possible side effects
5.
How to store Diacronal MR
6.
Contents of the pack and other information
1.
WHAT DIACRONAL MR IS AND WHAT IT IS USED FOR
Diacronal MR is a medicine that reduces blood sugar levels (oral
antidiabetic medicine belonging to
the sulfonylurea group).
Diacronal MR is used in a certain form of diabetes (type 2 diabetes
mellitus) in adults, when diet,
exercise and weight loss alone do not have an adequate effect on
keeping blood sugar at the correct
level.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIACRONAL MR
DO NOT TAKE DIACRONAL MR:
-
if you are allergic to gliclazide or to any of the other ingredients
of this medicine (listed in
section 6) or to other medicines of the same group (sulfonylureas) or
to other related medicines
(hypoglycaemic sulfonamides),
-
if you have insulin-dependent diabetes (type 1),
-
if you have ketone bodies and sugar in the urine (this may mean you
have diabetic keto-
acidosis), a diabetic pre-coma or coma,
-
if you have severe kidney or liver disease,
-
if you are taking medicines to treat fungal infections (miconazole,
see section ‘Other medicines
and Diacronal MR’),
-
if you are breast feeding (see section ‘Pregnancy and
breast-feeding’).
WARNING AND PRECAUTIONS
Talk to your

Preparatomtale

Health Products Regulatory Authority
06 January 2021
CRN009ZHY
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diacronal MR 30 mg modified-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release tablet contains 30 mg gliclazide.
Excipient(s) with known effect
Each modified-release tablet contains 73.5 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release tablet
The modified-release tablets are white, oval, biconvex.
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.
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, HbA1c).
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 gliclazide 80 mg tablets (immediate release
formulation) to Diacronal MR 30 mg modified-release tablets
1 tablet of gliclazide 80 mg is comparable to 1 Diacronal MR
modified-release tablet 30 mg. Consequently, the switch can be
performed provided a careful blood glucose monitoring.
Switching from another oral antidiabetic agent