BUSCOPAN RX 10 Milligram Coated Tablets

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

HYOSCINE BUTYLBROMIDE

Dostupno od:

Boehringer Ingelheim Limited

ATC koda:

A03BB01

INN (International ime):

HYOSCINE BUTYLBROMIDE

Doziranje:

10 Milligram

Farmaceutski oblik:

Coated Tablets

Tip recepta:

Product subject to prescription which may be renewed (B)

Područje terapije:

Belladonna alkaloids, semisynthetic, quaternary ammonium compounds

Status autorizacije:

Authorised

Datum autorizacije:

2016-12-02

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 troublesome
or serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET: 
1.   What Buscopan Rx 10mg Coated
Tablets are and what they are used for
2. Before you take Buscopan Rx 10mg
Coated Tablets
3. How to take Buscopan Rx 10mg
Coated Tablets
4. Possible side effects
5. How to store Buscopan Rx 10mg
   Coated Tablets
6. Further information
1.   WHAT BUSCOPAN RX 10MG COATED 
TABLETS ARE AND WHAT THEY ARE 
USED FOR 
Buscopan Rx 10mg Coated Tablets
contain a medicine called “hyoscine
butylbromide”. This belongs to a group of
medicines called “antispasmodics”.
Buscopan Rx 10mg Coated Tablets are used
to relieve cramps in the muscles of your:
• Stomach
• Gut (intestine)
• Bladder and the tubes that lead to the
outside of your body (urinary system)
2.  BEFORE YOU TAKE BUSCOPAN RX 
10MG COATED TABLETS
DO NOT TAKE BUSCOPAN RX 10MG COATED 
TABLETS IF: 
• You are allergic (hypersensitive) to
hyoscine butylbromide or any of the
other ingredients (listed in section 6)
• You have glaucoma (an eye problem)
• You have megacolon (a very enlarged
bowel)
• You have something called “myasthenia
gravis” (a very rare muscle weakness
problem)
• You are pregnant, likely to get pregnant,
or are breast-feeding
Do not take this medicine if any of the
above apply to you. If you are not sure,
talk to your doctor or pharmacist before
taking this medicine.
TAKE SPECIAL CARE WITH BUSCOPAN RX 
10MG COATED TABLETS 
Check with your doctor or pharmacist
before taking your medicine if:
• You have a very fast heart r

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Buscopan Rx 10mg Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg hyoscine butylbromide.
Excipient(s) with known effect: Sucrose (41.2 mg 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 Rx 10mg Coated Tablets are indicated for the relief of spasm
of the gastrointestinal and genito-urinary tract.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults: Two tablets (20 mg) four times daily.
Children aged 6-12 years: 1 tablet (10mg) three times daily.
Buscopan Rx 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 Rx 10mg Coated Tablets are not recommended for use in
children under
6 years of age.
Method of administration
Oral use.
Buscopan Rx 10mg Coated Tablets should be swallowed whole with
adequate water.
4.3 CONTRAINDICATIONS
Buscopan Rx 10mg Coated Tablets are contraindicated in patients with:
myasthenia gravis
megacolon
narrow angle glaucoma.
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
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