Diamicron

Страна: Мальта

Язык: английский

Источник: Medicines Authority

Активный ингредиент:

GLICLAZIDE

Доступна с:

Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France

код АТС:

A10BB09

ИНН (Международная Имя):

GLICLAZIDE

Фармацевтическая форма:

TABLET

состав:

GLICLAZIDE

Тип рецепта:

POM

Терапевтические области:

DRUGS USED IN DIABETES

Статус Авторизация:

Authorised

Дата Авторизация:

2005-10-07

тонкая брошюра

DIAMICRON
®
80 mg_03.2012
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DIAMICRON 80 MG, SCORED TABLET_ _
_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 is and what it is used for
2.
What you need to know before you take Diamicron
3.
How to take Diamicron
4.
Possible side effects
5.
How to store Diamicron
6.
Contents of the pack and other information
1. WHAT DIAMICRON IS AND WHAT IT IS USED FOR
DIAMICRON is a medicine that reduces blood sugar levels (oral
antidiabetic medicine belonging to the
sulfonylurea group).
DIAMICRON is recommended for type 2 diabetes, in cases where dietary
measures have failed.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIAMICRON
DO NOT TAKE DIAMICRON
-
if you are allergic to gliclazide or any of the other ingredients of
Diamicron (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) or
antibiotics (quinolones) see section
“Other medicines and Diamicron”);
-
if you are breastfeeding (see section “Pregnancy and
breastfeeding”).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Diamicron, modified release tablet.
You should observe the treatment p

Характеристики продукта

DIAMICRON
®
80 mg_03.2012
1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
DIAMICRON
80 mg, scored tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One scored tablet contains gliclazide 80 mg.
For the list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Scored tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non-insulin-dependent diabetes, in association with an adapted diet,
in cases where dietary measures
alone provide inadequate control of blood glucose levels.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
As with all hypoglycaemic agents, the dosage must be adapted to suit
each individual case (blood
glucose, HbA1c).
In the case of a transient disturbance of glucose control,
administration of the product for a short
period of time may be sufficient in a patient in whom the glucose
balance is normally well maintained
by dietary measures.
Initial dose:
The recommended initial dose is 1 tablet per day.
Dosage increments:
The dosage is usually adjusted in increments of 1 tablet depending on
the glycaemic response.
Dosage increments should be separated by at least 14 days.
Maintenance treatment:
The dosage varies from 1 to 3 tablets per day, 4 in exceptional cases.
The standard dosage is 2 tablets per day, taken as 2 daily doses.
_Special populations _
_Elderly_
- Begin the treatment with ½ tablet taken once a day.
- This dosage may be progressively increased until satisfactory
glucose control is obtained in the
patient, provided that an interval of at least 14 days is maintained
after each dosage increase and
blood sugar levels are monitored closely.
_Other high-risk patients _
In patients who are undernourished or with a marked change in their
general state or whose calorie
intake is irregular, and in patients with renal or hepatic
insufficiency, treatment must be initiated at
3
the lowest dose and the guidelines for dosage increases scrupulously
respected, so as to avoid any
hypoglycaemic reactions (cf. section 4.4).
_Patients receiving other oral hypoglycaemic