Zicron PR 30mg prolonged-release Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

GLICLAZIDE

Available from:

Bristol Laboratories Limited

ATC code:

A10BB09

INN (International Name):

GLICLAZIDE

Pharmaceutical form:

PROLONGED-RELEASE TABLET

Composition:

GLICLAZIDE 30 milligram(s)

Prescription type:

POM

Therapeutic area:

DRUGS USED IN DIABETES

Authorization status:

Authorised

Authorization date:

2014-08-30

Patient Information leaflet

Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER ZICRON PR
30 MG 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. See section 4.
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 Zicron PR30mg 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;
Page 2 of 8
- if you are taking medicines to treat fungal infections (miconazole,
see “Taking other medicines”);
- if you are breastf

Summary of Product characteristics

Page
1
of
12
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zicron PR 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.
Page
2
of
12
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 Gliclazide 80 mg tablets to Zicron PR
30mg prolonged-release tablets:
1 tablet of Gliclazide 80 mg is comparable to 1 tablet of Zicron PR
Modified-Release
30mg Tablets. Consequently the switch can be pe