DIAMICRON MR 60 mg modified-release tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
01-07-2022
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:
60 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:
2009-12-18
Patient Information leaflet
1
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 60MG, 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 may mean you
have diabetic keto-
acidosis
Read the complete document
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 60 mg modified-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One modified release tablet contains gliclazide 60 mg
Excipients with known effect: lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified release tablet.
White, oblong, tablet, 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 MR 30 mg modified release tablets. The
breakability of the DIAMICRON MR 60 mg modified release tablet enables
flex
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