Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Opella Healthcare France SAS T/A Sanofi, 82 Avenue Raspail, 94250 Gentilly, France
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.
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.
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.
Buscopan injection solution may be diluted with dextrose or sodium chloride 0.9% injection solutions.
Serious signs of poisoning following acute overdosage have not been observed in man. In the case of overdosage, anticholinergic symptoms such as urinary retention, dry mouth, reddening of the skin, tachycardia, inhibition of gastrointestinal motility, and transient visual disturbances may occur, and Cheynes-Stokes respiration has been reported.
Symptoms of Buscopan overdosage respond to parasympathomimetics. For patients with glaucoma, pilocarpine should be given locally. Cardiovascular complications should be treated according to usual therapeutic principles. In case of respiratory paralysis: intubation, artificial respiration should be considered. Catheterisation may be required for urinary retention.
In addition, appropriate supportive measures should be used.
Unopened: 36 months.
Once opened, use immediately and discard any unused contents.
Store below 30°C. Keep the ampoules in the outer carton.
1 ml clear glass (Ph. Eur. Type I) ampoules with coloured identification rings, marketed in cartons containing 10 ampoules.
For single use only. Any unused solution should be discarded.
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