Glucobay 50mg Tablets

국가: 몰타

언어: 영어

출처: Medicines Authority

유효 성분:

ACARBOSE

제공처:

Bayer Public Limited Company 400 South Oak Way, Reading Berkshire RG2 6AD, United Kingdom

ATC 코드:

A10BF01

INN (국제 이름):

ACARBOSE 50 mg

약제 형태:

TABLET

구성:

ACARBOSE 50 mg

처방전 유형:

POM

치료 영역:

DRUGS USED IN DIABETES

승인 상태:

Withdrawn

승인 날짜:

2006-10-27

환자 정보 전단

85959069
PMR 85959069 (AB/01-C_MU-201709656) Pantone: Black, Orange 021
0
GLUCOBAY
®
50MG TABLETS
ACARBOSE
PACKAGE LEAFLET: INFORMATION FOR THE USER
0
GLUCOBAY
®
50MG TABLETS
ACARBOSE
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 GLUCOBAY IS AND WHAT IT IS USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
GLUCOBAY
3
HOW TO TAKE GLUCOBAY
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE GLUCOBAY
6
CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT GLUCOBAY IS AND
WHAT IT IS USED FOR
The active ingredient in this medicine is
acarbose. This belongs to a group of medicines
called_ glucosidase inhibitors._
GLUCOBAY IS USED TO TREAT NON-INSULIN
DEPENDENT DIABETES.
It helps to control your blood sugar levels.
It works by slowing down the digestion of
carbohydrates_ (complex sugars)_ which reduces
the abnormally high blood sugar levels in your
body after each meal.
Glucobay can be used to treat diabetes when a
restricted diet alone or a restricted diet plus other
sugar-lowering drugs do not work well enough.
2
WHAT YOU NEED TO KNOW
BEFORE YOU TAKE GLUCOBAY
DO NOT TAKE GLUCOBAY:
•
IF YOU ARE ALLERGIC to acarbose or any of
the other ingredients of this medicine (listed
in section 6).
•
IF YOU ARE PREGNANT OR BREAST-FEEDING.
•
IF YOU HAVE INFLAMMATION OR ULCERATION
OF THE BOWEL, for example ulcerative colitis
or Crohn’s disease.
•
IF YOU HAVE AN OBSTRUCTION IN YOUR
INTESTINES, or are likely to get this.
•
IF YOU HAVE A SEVERE LIVER DISORDER
.
•
IF YOU HAVE AN INTESTINE DISEASE where
you do not digest or absorb

제품 특성 요약

1.3.1
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Glucobay 50 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
GLUCOBAY 50 MG TABLETS:
1 tablet contains 50 mg acarbose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet for oral administration.
White to yellow-tinged round, convex tablets of 7 mm diameter and 10
mm radius of
curvature with ‘G50’ on one side and the BAYER-cross on the other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
INDICATIONS
Glucobay is recommended for the treatment of non-insulin dependent
(NIDDM) diabetes
mellitus
in
patients inadequately
controlled
on
diet
alone,
or
on diet
and
oral
hypoglycaemic agents.
MODE OF ACTION
Glucobay
is
a
competitive
inhibitor
of
intestinal
alpha-glucosidases
with
maximum
specific
inhibitory
activity
against
sucrase.
Under
the
influence
of
Glucobay,
the
digestion of starch and sucrose into absorbable monosaccharides in the
small intestine is
dose-dependently delayed. In diabetic subjects, this results in a
lowering of postprandial
hyperglycaemia and a smoothing effect on fluctuations in the daily
blood glucose profile.
In
contrast
to
sulphonylureas
Glucobay
has
no
stimulatory
action
on
the
pancreas.
Treatment with Glucobay also results in a reduction of fasting blood
glucose and to
modest changes in levels of glycated haemoglobin (HbA
1
, HbA
1c
). The changes may be a
reduction or reduced deterioration in HbA
1
or HbA
1c
levels, depending upon the patient's
clinical status and disease progression. These parameters are affected
in a dose-dependent
manner by Glucobay.
Following oral administration, only 1-2% of the active inhibitor is
absorbed.
1.3.1
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4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Owing to the great individual variation of glucosidase activity in the
intestinal mucosa,
there is no fixed dosage regimen, and patients should be treated
according to clinical
response and tolerance of intestinal side-effects.
ADULTS
The recommended in