Glucobay 50 mg Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
25-02-2017
Summary of Product characteristics
(SPC)
16-11-2019
Active ingredient:
Acarbose
Available from:
Bayer Limited
ATC code:
A10BF; A10BF01
INN (International Name):
Acarbose
Dosage:
50 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
85300873
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.
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 a
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
15 November 2019
CRN009G88
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glucobay 50 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Acarbose 50 mg.
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
White to yellow-tinged round, convex tablets of 7 mm diameter and 10
mm radius of curvature. On one side the tablet code is
G and 50 and on the other side Bayer cross.
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
mouthful of food, or swallowed whole with a little liquid
directly before
Read the complete document
