Buscopan Rx 10mg Coated Tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Hyoscine butylbromide

Διαθέσιμο από:

Opella Healthcare France SAS T/A Sanofi

Φαρμακολογική κατηγορία (ATC):

A03BB; A03BB01

INN (Διεθνής Όνομα):

Hyoscine butylbromide

Δοσολογία:

10 milligram(s)

Φαρμακοτεχνική μορφή:

Coated tablet

Θεραπευτική περιοχή:

Belladonna alkaloids, semisynthetic, quaternary ammonium compounds; butylscopolamine

Ημερομηνία της άδειας:

2016-12-02

Φύλλο οδηγιών χρήσης

BUSCOPAN
® RX 10 MG TABLETS
(HYOSCINE BUTYLBROMIDE)
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 something called “myasthenia gravis” (a very rare muscle
weakness problem)
•
You have a suspected or confirmed blockage of the bowel
•
You have a condition where the bowel is blocked and does not work
properly (paralytic or
obstructive ileus). Symptoms include severe abdominal pain with lack
of stools and/or
nausea/vomiting
•
You have a very enlarged bowel (megacolon)
•
You are pregnant, likely to get pregnant, or are breast-feeding
Do not take this medicine if any of

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
15 November 2023
CRN00DRFC
Page 1 of 5
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 Tabletsare 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:
- Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
- myasthenia gravis
- mechanical stenosis in the gastrointestinal tract
- paralytical or obstructive ileus
- megacolon
- narrow angle glaucoma.
Health Products Regulatory Authority
15 November 2023
CRN00DRFC
Page 2 of 5
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In case severe, unexplained abdominal pain persists or worsens, or
occurs together with symptoms like fever, nausea, vomiting,
changes in bowel movements, abdominal tenderness, decreased blood
pressure, fainting or bl