Diamicron MR 30 mg modified-release tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
08-02-2022
Summary of Product characteristics
(SPC)
04-03-2020
Active ingredient:
Gliclazide
Available from:
Les Laboratoires Servier
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:
Marketed
Authorization date:
2000-11-24
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DIAMICRON
® 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 Diamicron MR 30 mg is and what it is used for
2.
What you need to know before you take Diamicron MR 30 mg
3.
How to take Diamicron MR 30 mg
4.
Possible side effects
5.
How to store Diamicron MR 30 mg
6.
Contents of the pack and other information
1. WHAT DIAMICRON MR 30 MG IS AND WHAT IT IS USED FOR
Diamicron MR 30 mg is a medicine that reduces blood sugar levels (oral
antidiabetic medicine
belonging to the sulfonylurea group).
Diamicron MR 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 MR
30 MG
DO NOT TAKE DIAMICRON MR 30 MG
-
if you are allergic to gliclazide or any of the other ingredients of
Diamicron MR 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 sect
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Summary of Product characteristics
Health Products Regulatory Authority
03 March 2020
CRN008YXF
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diamicron MR 30 mg modified-release 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 MR 30 mg
modified release tablets:
1 tablet of Diamicron 80 mg is comparable to1 tablet of DIAMICRON MR
30 mg. Consequently the switch can be performed
with careful blood monitoring.
• Switching from another oral antidiabetic agent to DIAMICRON MR 30
mg:
DIAMICRON MR 30 mg can be used to replace other oral ant
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