Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, SUGAR COATED
**Dosage and Administration** Unless otherwise prescribed by the physician, the following dosages are recommended: Sugar-coated tablets: Adults and children over 6 years: 3 – 5 times daily 1 – 2 s.c. tablets The tablets should be swallowed whole with adequate fluid. **Buscopan®** should not be taken on a continuous daily basis or for extended periods without investigating the cause of abdominal pain.
ORAL
Medical Information
**Indications** Gastro-intestinal tract spasm, spasm and dyskinesia of the biliary system, genito-urinary tract spasm.
**Contraindications** **Buscopan®** is contraindicated in: - patients who have demonstrated prior hypersensitivity to hyoscine butylbromide or any other component of the product - myasthenia gravis - mechanical stenosis in the gastrointestinal tract - paralytical or obstructive ileus - megacolon - narrow angle glaucoma In case of rare hereditary conditions that may be incompatible with an excipient of the product (please refer to “special warnings and precautions” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) the use of the product is contraindicated.
A03BB01
butylscopolamine
Manufacturer Information
OPELLA HEALTHCARE SINGAPORE PTE. LTD.
Delpharm Reims
Active Ingredients
Documents
Package Inserts
Buscopan Tablet PI.pdf
Approved: May 4, 2022