BUSCOPAN AMPOULES 20 Mg/Ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

HYOSCINE BUTYLBROMIDE

Available from:

Boehringer Ingelheim Limited

ATC code:

A03BB01

INN (International Name):

HYOSCINE BUTYLBROMIDE

Dosage:

20 Mg/Ml

Pharmaceutical form:

Solution for Injection

Prescription type:

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

Therapeutic area:

Belladonna alkaloids, semisynthetic, quaternary ammonium compounds

Authorization status:

Authorised

Authorization date:

1979-04-01

Patient Information leaflet

TRADE NAME OF THE MEDICINAL PRODUCT
BUSCOPAN Ampoules 20 mg/ml solution for injection.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml ampoule contains 20 mg hyoscine butylbromide. For
excipients, see List of excipients
PHARMACEUTICAL FORM
Solution for injection. A colourless or almost colourless, clear
solution.
CLINICAL PARTICULARS
_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.
_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 with sodium chloride 0.9% injection solutions.
_CONTRAINDICATIONS_
BUSCOPAN Ampoules should not be administered to patients with
myasthenia gravis, megacolon, narrow angle glaucoma, tachycardia,
prostatic enlargement with urinary retention, mechanical stenoses
in the region of the gastrointestinal tract or paralytic ileus.
BUSCOPAN should not be used in patients who have demonstrated
prior hypersensitivity to hyoscine butylbromide or any other
component of the product.
BUSCOPAN Ampoules should not be given

Summary of Product characteristics

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 should not be administered to patients with
myasthenia gravis, megacolon, narrow angle
glaucoma, tachycardia, prostatic enlargement with urinary retention,
mechanical stenoses in the region of the
gastrointestinal tract, or paralytic ileus.
Buscopan should not be used in patients who have demonstrated prior
hypersensitivity to hyoscine butylbromide or any
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