Diamicron MR Tablets 60

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

GLICLAZIDE

Available from:

Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France

ATC code:

A10BB09

INN (International Name):

GLICLAZIDE

Pharmaceutical form:

MODIFIED-RELEASE TABLET

Composition:

GLICLAZIDE

Prescription type:

POM

Therapeutic area:

DRUGS USED IN DIABETES

Authorization status:

Authorised

Authorization date:

2009-12-14

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DIAMICRON
MR
60 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 Diamicron MR 60 mg, modified release tablet is and what it is
used for
2.
What you need to know before you take Diamicron MR 60 mg, modified
release tablet
3.
How to take Diamicron MR 60 mg, modified release tablet
4.
Possible side effects
5.
How to store Diamicron MR 60 mg, modified release tablet
6. Contents of the pack and other information
1. WHAT DIAMICRON MR 60 MG, MODIFIED RELEASE TABLET IS AND WHAT IT IS
USED FOR
Diamicron MR 60 mg, modified release tablet is a medicine that reduces
blood sugar levels (oral
antidiabetic medicine belonging to the sulfonylurea group). Diamicron
MR 60 mg, modified release
tablet 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 DIAMICRON
MR 60 MG, MODIFIED RELEASE TABLET
DO NOT TAKE DIAMICRON MR 60 MG
,
MODIFIED RELEASE TABLET:
-
if you are allergic to gliclazide or any of the other ingredients of
Diamicron MR 60 mg,
modified release tablet (listed in section 6), or to other medicines
of the same group
(sulfonylurea), or to other related medicines (hypoglycaemic
sulfonamides);
-
if you have insulin-dependent diabetes (type 1);
-
if you have ketone bodies and sugar in your urine (this m

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
DIAMICRON MR 60 mg, modified release tablet.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One modified release tablet contains gliclazide 60 mg
Excipient with known effect: lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified release tablet.
White, oblong, tablet, 15 mm long and 7 mm wide, scored and engraved,
with ‘DIA 60’ on both
faces.
The tablet can be divided into equal doses.
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 of DIAMICRON MR 60 mg 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
DIAMICRON MR 60 mg). 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 DIAMICRON MR 60 mg modified release tablet is equivalent to two
DIAMICRON 30 mg
modified release tablets. The breakability of the DIAMICRON MR 60 mg
modified release tablet
enables flexibility of dosing t