Glucobay 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Acarbose

Available from:

Dowelhurst Ltd

ATC code:

A10BF01

INN (International Name):

Acarbose

Dosage:

100mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06010203

Patient Information leaflet

GLUCOBAY 100MG TABLETS
(acarbose)
PATIENT INFORMATION LEAFLET
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.
Your medicine is called Glucobay 100mg Tablets but will be referred to
as
Glucobay throughout the leaflet.
WHAT IS IN THIS LEAFLET:
What Glucobay is and what it is used for
What you need to know before you take Glucobay
How to take Glucobay
Possible side effects
How to store Glucobay
Contents of the pack and other information
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.
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
food
properly.
*
IF YOU HAVE A LARGE H

Summary of Product characteristics

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.
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 initial dose is 50 mg three times a d