BUSCOPAN 10 Milligram Coated Tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

HYOSCINE BUTYLBROMIDE

Boleh didapati daripada:

Boehringer Ingelheim Limited

Kod ATC:

A03BB01

INN (Nama Antarabangsa):

HYOSCINE BUTYLBROMIDE

Dos:

10 Milligram

Borang farmaseutikal:

Coated Tablets

Jenis preskripsi:

Product not subject to medical prescription

Kawasan terapeutik:

Belladonna alkaloids, semisynthetic, quaternary ammonium compounds

Status kebenaran:

Authorised

Tarikh kebenaran:

1979-04-01

Risalah maklumat

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 the precise cause of abdominal cramps
and

Ciri produk

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
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