ZYCRON MR 30 Milligram Modified-release Tablets

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

GLICLAZIDE

Доступна с:

Clonmel Healthcare Ltd

код АТС:

A10BB09

ИНН (Международная Имя):

GLICLAZIDE

дозировка:

30 Milligram

Фармацевтическая форма:

Modified-release Tablets

Тип рецепта:

Product subject to prescription which may be renewed (B)

Терапевтические области:

Sulfonylureas

Статус Авторизация:

Authorised

Дата Авторизация:

2014-01-24

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZYCRON 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 Zycron MR is and what it is used for
2. What you need to know before you take Zycron MR
3. How to take_ _Zycron MR
4. Possible side effects
5. How to store Zycron MR
6. Contents of the pack and other information
1. WHAT ZYCRON MR IS AND WHAT IT IS USED FOR
Zycron MR is a medicine that reduces blood sugar levels (oral
antidiabetic medicine belonging to the
sulphonylurea group).
Zycron 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 ZYCRON MR
DO NOT TAKE ZYCRON MR:

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 (sulphonylureas), or to other
related medicines (hypoglycaemic
sulphonamides);

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
Zycron MR”);

if you are breast-feeding (see section “Pregnancy and
breast-feeding”).
WARNINGS AND PRECAUTIONS
Talk to your d

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zycron MR 30 mg modified-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 30 mg gliclazide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release tablet.
White to off-white capsule shaped, biconvex tablet with the punch
dimension (size) of 9.8 mm x 4.3 mm debossed with
“30” on one side, and plain on the other side.
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.
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, HbA1c).
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 Gliclazide 80 mg tablets to Gliclazide 30 mg modified
release tablets
1 tablet of Gliclazide 80mg is comparable to 1 tablet of Gliclazide 30
mg modified release tablets.
Consequently the
switch can be performed with careful blood monitoring.
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