Diacronal MR 60 mg modified-release tablets

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Gliclazide

Доступна с:

KRKA, d.d., Novo mesto

код АТС:

A10BB; A10BB09

ИНН (Международная Имя):

Gliclazide

дозировка:

60 milligram(s)

Фармацевтическая форма:

Modified-release tablet

Тип рецепта:

Product subject to prescription which may be renewed (B)

Терапевтические области:

Sulfonamides, urea derivatives; gliclazide

Статус Авторизация:

Marketed

Дата Авторизация:

2013-02-22

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DIACRONAL 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 Diacronal MR is and what it is used for
2.
What you need to know before you take Diacronal MR
3.
How to take Diacronal MR
4.
Possible side effects
5.
How to store Diacronal MR
6.
Contents of the pack and other information
1.
WHAT DIACRONAL MR IS AND WHAT IT IS USED FOR
Diacronal MR is a medicine that reduces blood sugar levels
(antidiabetic medicine taken orally,
belonging to the sulphonylurea group).
Diacronal MR 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 DIACRONAL MR
DO NOT TAKE DIACRONAL 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 substance group
(sulphonylureas) or to other related
medicines (hypoglycaemic sulphonamides);
-
if you have insulin-dependent diabetes (type I);
-
if you have ketone bodies and sugar in your urine (this may mean that
you have diabetic
ketoacidosis), a diabetic precoma or coma;
-
if you have severe kidney or liver disease;
-
if you are taking medicines to treat fungal infections (miconazole,
see section "Taking
Diacronal MR with other medicines");
-
if you are breast feeding (see section "Pregnancy and
breast-feeding").
WARNINGS AND PRE

Характеристики продукта

Health Products Regulatory Authority
08 January 2021
CRN009ZHX
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diacronal MR 60 mg modified-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified‑release tablet contains 60 mg gliclazide.
Excipient(s) with known effect
Each modified‑release tablet contains 88.7 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release tablet.
White to almost white, oval, biconvex tablet, 13mm long and with a
thickness of 3.5 mm to 4.9 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Non‑insulin dependent Diabetes mellitus (Type II) 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 DIACRONAL MR MAY VARY 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
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 initial 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.
ONE DIACRONAL MR 60 MG MODIFIED‑RELEASE TABLET CORRESPONDS TO TWO
DIACRONAL MR 30 MG MODIFIED‑RELEASE TABLETS.
Health Products Regulatory Authority
08 January 2021
CRN009ZHX
Page 2 of 9
SWITCHING FROM GLICLAZIDE (80 MG) TABLETS (IMMEDIATE RELEASE
FORMULATION) TO DIACRONAL MR 60 MG TABLETS WITH
MODIFIED RELEASE
One