Buscopan Ampoules 20 mg/ml Solution for Injection

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Hyoscine butylbromide

Fáanlegur frá:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC númer:

A03BB; A03BB01

INN (Alþjóðlegt nafn):

Hyoscine butylbromide

Skammtar:

20 milligram(s)/millilitre

Lyfjaform:

Solution for injection

Gerð lyfseðils:

Product subject to prescription which may not be renewed (A)

Lækningarsvæði:

Belladonna alkaloids, semisynthetic, quaternary ammonium compounds; butylscopolamine

Leyfisstaða:

Marketed

Leyfisdagur:

1979-04-01

Upplýsingar fylgiseðill

Package Leaflet: Information for the user
______________________________________________
781885
148x500
12
BUSCOPAN
® AMPOULES
20 MG/ML SOLUTION FOR INJECTION
(hyoscine butylbromide)
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 Ampoules are and what they are
used for
2. Before you receive BUSCOPAN Ampoules
3. How BUSCOPAN Ampoules will be given
4. Possible side effects
5. How to store BUSCOPAN Ampoules
6. Further information
1.
WHAT
BUSCOPAN
AMPOULES
ARE
AND
WHAT THEY ARE USED FOR
The name of your medicine is BUSCOPAN Ampoules
20 mg/ml Solution for injection (called BUSCOPAN
Ampoules in this leaflet).
BUSCOPAN
Ampoules
contain
a
medicine
called
‘hyoscine butylbromide’. This belongs to a group of
medicines called ‘antispasmodics’.
BUSCOPAN Ampoules are used to relieve cramps in
the muscles of your:
• Stomach
• Gut (intestine)
• Bladder and the tubes leading to the outside of your
body (urinary system)
BUSCOPAN
Ampoules
can
also
be
used
in
some
diagnostic and therapeutic medical procedures where
spasm may be a problem for example barium enema.
2. BEFORE YOU RECEIVE BUSCOPAN AMPOULES
YOU SHOULD NOT BE GIVEN BUSCOPAN AMPOULES
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 have a very fast heart rate
• You have difficulty or pain passing water (urine) such
as men with

Vara einkenni

Health Products Regulatory Authority
14 April 2020
CRN009FYG
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Buscopan Ampoules 20 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml ampoule contains 20 mg Hyoscine Butylbromide.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection
A colourless or almost colourless, clear solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Buscopan ampoules are indicated in acute spasm, as in renal or biliary
colic; in radiology for differential diagnosis of
obstruction and to reduce spasm and pain in pyelography and in other
diagnostic procedures where spasm may be a problem,
e.g. gastro-duodenal endoscopy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
One ampoule (20 mg) intramuscularly or intravenously, repeated after
half-an-hour if necessary. Intravenous injection should
be performed slowly, (in rare cases a marked drop in blood pressure
and even shock may be produced by Buscopan). When
used in endoscopy this dose may need to be repeated more frequently.
Maximum daily dose of 100 mg.
Special populations:
Elderly: 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:
Not recommended for children.
Buscopan Ampoules should not be taken on a continuous daily basis or
for extended periods without investigating the cause
of abdominal pain.
Diluent:
Buscopan injection solution may be diluted with dextrose or sodium
chloride 0.9% injection solutions.
4.3 CONTRAINDICATIONS
Buscopan Ampoules are contraindicated in patients with:
- hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
- narrow angle glaucoma
- hypertrophy of the prostate with urinary retention
- mechanical stenosis in the gastrointestinal tract
- paralytical or obstructive ileus
- megacolon
- tachycard