Glucobay 100mg Tablets

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

ACARBOSE

Beschikbaar vanaf:

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

ATC-code:

A10BF01

INN (Algemene Internationale Benaming):

ACARBOSE 100 mg

farmaceutische vorm:

TABLET

Samenstelling:

ACARBOSE 100 mg

Prescription-type:

POM

Therapeutisch gebied:

DRUGS USED IN DIABETES

Autorisatie-status:

Withdrawn

Autorisatie datum:

2006-10-27

Bijsluiter

85959115
0
Glucobay
®
100mg tablets
ACARBOSE
PACKAGE LEAFLET: INFORMATION FOR THE USER
0
Glucobay
®
100mg 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:
s
IF YOU ARE ALLERGIC to acarbose or any of
the other ingredients of this medicine (listed
in section 6).
s
IF YOU ARE PREGNANT OR BREAST-FEEDING.
s
IF YOU HAVE INFLAMMATION OR ULCERATION
OF THE BOWEL, for example ulcerative colitis
or Crohn’s disease.
s
IF YOU HAVE AN OBSTRUCTION IN YOUR
INTESTINES, or are likely to get this.
s
IF YOU HAVE A SEVERE LIVER DISORDER
.
s
IF YOU HAVE AN INTESTINE DISEASE where
you do not digest or absorb food properly.
s
IF YOU HAVE A LARGE HERNIA, or any other
condition wher

Productkenmerken

1.3.1
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Glucobay 100 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
GLUCOBAY 100 MG TABLETS:
1 tablet contains 100 mg acarbose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet for oral administration.
White to yellow-tinged oval oblong, convex tablets of 13 mm length, 6
mm width and 5.5 mm
radius of curvature with ‘G score 100’ on one side and a
‘score’ on the other.
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.
ADU