Buscopan 10 mg Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Hyoscine butylbromide

Available from:

Opella Healthcare France SAS T/A Sanofi

ATC code:

A03BB; A03BB01

INN (International Name):

Hyoscine butylbromide

Dosage:

10 milligram(s)

Pharmaceutical form:

Coated tablet

Therapeutic area:

Belladonna alkaloids, semisynthetic, quaternary ammonium compounds; butylscopolamine

Authorization status:

Marketed

Authorization date:

1979-04-01

Patient Information leaflet

BUSCOPAN
®
10MG COATED TABLETS
(HYOSCINE BUTYLBROMIDE)
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING BUSCOPAN
10MG COATED TABLETS, BECAUSE
IT CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to use it again.
•
Ask your pharmacist if you need more information or advice.
•
You must stop taking and talk to your pharmacist or doctor if you do
not feel better after two
weeks of treatment, or if you feel worse.
•
If you get any side effects, talk to your pharmacist or doctor. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Buscopan 10mg Coated Tablets are and what they are used for
2.
What you need to know before you take Buscopan 10mg Coated Tablets
3.
How to take Buscopan 10mg Coated Tablets
4.
Possible side effects
5.
How to store Buscopan 10mg Coated Tablets
6.
Contents of the pack and further information
1. WHAT BUSCOPAN 10MG COATED TABLETS ARE AND WHAT THEY ARE USED FOR
Buscopan 10mg Coated Tablets are tablets that contain ‘hyoscine
butylbromide’. They belong to a
group of medicines called ‘anti-spasmodics’.
This medicine is used to relieve abdominal cramps which cause pain and
discomfort associated with
your digestive tract, and in Irritable Bowel Syndrome (IBS). It works
by relaxing the cramping
muscles of your stomach and bowel.
WHAT ARE ABDOMINAL CRAMPS?
Abdominal cramps (or spasms) are due to the sudden, irregular
tightening up of muscles in the wall of
your stomach or bowel.
WHAT IS IRRITABLE BOWEL SYNDROME (IBS)?
Irritable Bowel Syndrome or IBS is a group of symptoms that can
include abdominal pain, cramps,
spasms, bloating, and a change in bowel habit (diarrhoea or
constipation). These symptoms may come
and go over a period of time and you may not have all these symptoms.
You can use Buscopan 10mg
Coated Tablets to help relieve the pain of the cramping spasm but it
is important to see a doctor to
then have a diagnosis of IBS confirmed.
While t

Summary of Product characteristics

Health Products Regulatory Authority
15 November 2023
CRN00DRFC
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Buscopan 10 mg Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg hyoscine butylbromide.
Excipient(s) with known effect: Sucrose (41.2mg per tablet)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet
Round, white, biconvex sugar-coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Buscopan 10mg Coated Tablets are indicated for the relief of spasm of
the gastrointestinal tract and for the symptomatic relief
of Irritable Bowel Syndrome.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Relief of spasm of gastrointestinal tract
Adults and children over 12 years: Two tablets (20 mg) four times
daily.
For the symptomatic relief of Irritable Bowel Syndrome
Adults and children over 12 years: The recommended starting dose is 1
tablet up to three times daily, this can be increased up
to 2 tablets four times daily if necessary.
If symptoms do not improve or if they worsen after 2 weeks of
treatment a doctor should be consulted.
Buscopan 10mg Coated Tablets should not be taken on a continuous daily
basis or for extended periods without investigating
the cause of abdominal pain.
No specific information on the use of this product in the elderly is
available. Clinical trials have included patients over 65 years
and no adverse reactions specific to this age group have been
reported.
_Paediatric population_
Buscopan 10mg Coated Tablets are not recommended for use in children
under 12 years of age.
Method of administration
Oral use.
Buscopan 10mg Coated Tablets should be swallowed whole with adequate
water.
Health Products Regulatory Authority
15 November 2023
CRN00DRFC
Page 2 of 6
4.3 CONTRAINDICATIONS
Buscopan 10 mg Coated Tablets are contraindicated in patients with:
- Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
- myasthenia gravis
- mechanical stenosis in