BUSCOPAN Coated tablets Ref.[6355] Active ingredients: Butylscopolamine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom Trading as: Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom

Therapeutic indications

Buscopan 10 mg Tablets are indicated for the relief of spasm of the genito-urinary tract or gastro-intestinal tract and for the symptomatic relief of Irritable Bowel Syndrome.

Posology and method of administration

Buscopan 10 mg Tablets are for oral administration only.

Buscopan 10 mg Tablets should be swallowed whole with adequate water.

Adults: 2 tablets four times daily. For the symptomatic relief of Irritable Bowel Syndrome, the recommended starting dose is 1 tablet three times daily, this can be increased up to 2 tablets four times daily if necessary.

Children 6-12 years: 1 tablet three times daily.

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.

Buscopan 10 mg Tablets should not be taken on a continuous daily basis or for extended periods without investigating the cause of abdominal pain.

Overdose

Symptoms

Serious signs of poisoning following acute overdosage have not been observed in man. In the case of overdosage, anticholinergic effects 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.

Therapy

In the case of oral poisoning, gastric lavage with medicinal charcoal should be followed by magnesium sulfate (15%). 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 and artificial respiration should be considered. Catheterisation may be required for urinary retention.

In addition, appropriate supportive measures should be administered as required.

Shelf life

Shelf life: Five years.

Special precautions for storage

Buscopan 10 mg Tablets should be protected from light and stored in a dry place below 25°C.

Nature and contents of container

Blister packs of 56, 100, 500 and 560.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

None stated.

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