Diamicron MR Tablets 30
국가: 몰타
언어: 영어
출처: Medicines Authority
환자 정보 전단 유효 성분:
GLICLAZIDE
제공처:
Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France
ATC 코드:
A10BB09
INN (International Name):
GLICLAZIDE
약제 형태:
MODIFIED-RELEASE TABLET
구성:
GLICLAZIDE
처방전 유형:
POM
치료 영역:
DRUGS USED IN DIABETES
승인 상태:
Withdrawn
승인 날짜:
2005-08-01
환자 정보 전단
Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIAMICRON
®
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.
WHAT IS IN THIS LEAFLET
1. What Diamicron MR 30 mg is and what it is used for
2. What you need to know before you take Diamicron MR 30
mg
3. How to take Diamicron MR 30 mg
4. Possible side effects
5. How to store Diamicron MR 30 mg
6. Contents of the pack and other information
1. WHAT DIAMICRON MR 30 MG IS AND WHAT IT IS USED FOR
Diamicron R 30
mg is a medicine that reduces blood sugar levels
(oral antidiabetic medicine belonging to
the sulphonylurea group).
Diamicron 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 DIAMICRON MR 30
MG
DO NOT TAKE DIAMICRON MR 30 MG
-
if you
are allergic to gliclazide or any of the other ingredients of Diamicron MR 30
mg (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
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제품 특성 요약
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
DIAMICRON MR 30 MG, modified release tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains gliclazide 30 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified release tablet.
White, oblong tablet engraved on both faces, ‘DIA 30’ on
one face and
on the other.
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
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.
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 Diamicron 80
mg tablets to Diamicron MR 30 mg modified release tablets:
1 table
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