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Prescribing information & SmPC

Prescribing information

Buscopan® 10 mg Tablets Prescribing Information.

Presentation: Tablets containing hyoscine butylbromide 10 mg. Indications: Buscopan 10 mg Tablets are indicated for the relief of spasm of the genitourinary tract or gastro-intestinal tract and for the symptomatic relief of Irritable Bowel Syndrome. Dosage and administration: For spasm of the gastro-intestinal tract or genito-urinary tract. Buscopan 10 mg Tablets are for oral administration only. 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. For Irritable Bowel Syndrome: 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. Contraindications: Myasthenia gravis, mechanical stenosis in the gastrointestinal tract, paralytical or obstructive ileus, megacolon, narrow angle glaucoma, known hypersensitivity to hyoscine butylbromide or any other component. Warnings and precautions: 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 blood in stool, medical advice should immediately be sought. Use with caution in conditions characterised by tachycardia; those susceptible to intestinal or urinary outlet obstruction; pyrexia. Elevation of intraocular pressure may be produced by the administration of anticholinergic agents such as Buscopan in patients with undiagnosed and therefore untreated narrow angle glaucoma. Warn patients to seek medical advice if they develop a painful red eye with loss of vision whilst or after taking Buscopan Tablets. As the tablet coat contains sucrose (41.2 mg), patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take Buscopan Tablets since the tablet coat contains sucrose. Interactions: The anticholinergic effect of drugs, e.g. tri- and tetracyclic antidepressants, antihistamines, quinidine, amantadine, antipsychotics (e.g. butyrophenones, phenothiazines), disopyramide and other anticholinergics (e.g. tiotropium, ipratropium, atropine-like compounds) may be intensified by Buscopan Tablets. Co-administration with a dopamine antagonist may diminish the effect of both medicines. The tachycardic effects of betaadrenergic agents may be enhanced by Buscopan Tablets. Fertility, pregnancy & lactation: Use during pregnancy and breastfeeding is not recommended. No studies on the effects on human fertility have been conducted. Undesirable effects: Uncommon: dry mouth, tachycardia, skin reactions (e.g. urticaria, pruritus), abnormal sweating. Rare: urinary retention. Not known: anaphylactic shock, anaphylactic reactions, dyspnoea, rash, erythema, other hypersensitivity. Pack sizes and NHS price: 56 tablets £3.00, 100 tablets £5.35. Legal category: POM. Marketing authorisation number: PL 04425/0708 Marketing authorisation holder: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Further information is available from: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT. Email: uk-medicalinformation@sanofi.com
Date of preparation: July 2020

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov/yellowcard or search for MHRA Yellow Card on the Google Play or Apple App Store.
Adverse events should also be reported to Sanofi drug safety department on 0800 0902314
Alternatively, send via email to UK-drugsafety@sanofi.com

Summary of Product Characteristics

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