Glucobay 100 mg Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
27-09-2017
Summary of Product characteristics
(SPC)
19-11-2019
Active ingredient:
Acarbose
Available from:
Bayer Limited
ATC code:
A10BF; A10BF01
INN (International Name):
Acarbose
Dosage:
100 milligram(s)
Pharmaceutical form:
Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Alpha glucosidase inhibitors; acarbose
Authorization status:
Not marketed
Authorization date:
1992-06-04
Patient Information leaflet
BP14115
PACKAGE LEAFLET - INFORMATION FOR
THE USER
GLUCOBAY
100 MG TABLETS
ACARBOSE
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS
MEDICINE.
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. Do not pass it on to others. It
may harm them, even if their
symptoms are the same as yours.
If any of the side effects gets serious,
or if you notice any side effect not
listed in this leaflet, please tell your
doctor or pharmacist.
IN THIS LEAFLET:
1.
WHAT GLUCOBAY IS AND WHAT IT
IS USED FOR
2.
BEFORE YOU TAKE GLUCOBAY
3.
HOW YOU TAKE GLUCOBAY
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE GLUCOBAY
6.
FURTHER INFORMATION
1.
WHAT GLUCOBAY IS AND WHAT IT
IS USED FOR
Glucobay contains acarbose, which
belongs to a group of medicines called
_glucosidase inhibitors._
GLUCOBAY IS USED TO TREAT DIABETES
Glucobay 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 enough.
2.
BEFORE YOU TAKE GLUCOBAY
DO NOT TAKE GLUCOBAY:
•
IF YOU ARE ALLERGIC to the active
ingredient (acarbose), or to any
of the other ingredients. The
ingredients are listed in section
6.
•
IF YOU ARE PREGNANT OR
BREASTFEEDING.
•
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 AN INTESTINE
DISEASE where you do not digest
or absorb food properly.
•
IF YOU HAVE A LARGE HERNIA, or
any other condition where
increased gas in your intestine
may make it worse.
•
IF YOU HAVE SEVERE LIVER
IMPAIRMENT (e.g. liver cirrhosis)
•
IF YOU HAVE SEVERE RENAL
IMPAIRMENT.
→TELL YOUR DOCTOR if any of these
apply to you and DO N
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
18 November 2019
CRN009GFY
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glucobay 100 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Acarbose 100 mg.
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Tablets
White to yellow-tinged oval oblong, convex tablets of 13 mm length, 6
mm width and 5.5 mm radius of curvature. On one side
the tablet code is ‘G’, score and 100 and on the other side score.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
INDICATIONS
Glucobay is recommended:
1. as an adjunct to diet, in combination with insulin, in the
management of insulin dependent diabetes mellitus (IDDM), or
2. as an adjunct to diet, alone or in combination with insulin or oral
hypoglycaemic agents, in the management of non-insulin
dependent diabetes mellitus (NIDDM).
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
Glucobay tablets are taken orally and should be chewed with the first
mo
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