DIAMICRON 30 mg, modified release tablet

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 30 mg

Pharmaceutical form:

MODIFIED-RELEASE TABLET

Composition:

GLICLAZIDE 30 mg

Prescription type:

POM

Therapeutic area:

DRUGS USED IN DIABETES

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-03-23

Patient Information leaflet

1
PACKAGE LEAFLET
Page
2
of
8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DIAMICRON
® 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 Diamicron 30 mg is and what it is used for
2.
What you need to know before you take Diamicron
30 mg
3.
How to take Diamicron
30 mg
4.
Possible side effects
5.
How to store Diamicron 30 mg
6.
Contents of the pack and other information
1. WHAT DIAMICRON 30 MG IS AND WHAT IT IS USED FOR
Diamicron 30 mg is a medicine that reduces blood sugar levels (oral
antidiabetic medicine belonging to the
sulfonylurea group).
Diamicron 30 mg 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 30 MG
DO NOT TAKE DIAMICRON 30 MG
-
if you are allergic to gliclazide or any of the other ingredients of
Diamicron 30 mg (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 your 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
Diamicron 30 mg”);
-
if you are breastfeeding (see section

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
DIAMICRON 30 MG
, modified release tablet.
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. Consequently the
switch can be performed provided a careful blood monitoring.
•
Switching from another oral antidiabetic agent to Diamicron 30 mg:
Diamicron 30 mg can be used to replace other oral antidiabetic agents.
The dosage and the half-life of the previ