Gliclazide MR 30 mg prolonged-release tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
07-09-2017
Summary of Product characteristics
(SPC)
26-01-2019
Active ingredient:
Gliclazide
Available from:
Bristol Laboratories Limited
ATC code:
A10BB; A10BB09
INN (International Name):
Gliclazide
Dosage:
30 milligram(s)
Pharmaceutical form:
Prolonged-release tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Sulfonamides, urea derivatives; gliclazide
Authorization status:
Not marketed
Authorization date:
2014-09-12
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER GLICLAZIDE MR 30MG PROLONGED-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.
WHAT IS IN THIS LEAFLET
1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS MEDICINE
3. HOW TO TAKE THIS MEDICINE
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE THIS MEDICINE
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
The name of your medicine is Gliclazide MR 30mg prolonged-release
tablets. The active
ingredient is Gliclazide. It reduces blood sugar levels (oral
antidiabetic medicine belonging to the
sulfonylurea group).
This medicine 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 THIS MEDICINE
DO NOT TAKE THIS MEDICINE
if you are ALLERGIC to gliclazide or 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 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 “Taking other
medicines”);
if you are BREASTFEEDINg (see section
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
25 January 2019
CRN008R5F
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gliclazide MR 30mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 30 mg of gliclazide
Excipients with known effect: Also contains 29 mg of lactose (in the
form of lactose
monohydrate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged -release tablet
White to off white, capsule shaped, biconvex tablets debossed with
‘C12’ on one side
and plain on the other side. The tablet dimensions are 10.00 mm x 4.00
mm.
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.
Health Products Regulatory Authority
25 January 2019
CRN008R5F
Page 2 of 13
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 to Gliclazide MR tablets:
1 tablet of Gliclazide
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