The Pharmaceutical Journal
Vol 271 No 7257 p38
12 July 2003

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Buscopan move to GSL sought

The manufacturer of Buscopan (hyoscine butylbromide) is seeking reclassification of the drug to a general sale list medicine.

Boehringer Ingelheim says that reclassification is appropriate because the product has been available for over 45 years, including more than 10 years as a pharmacy medicine. For GSL sale, the product would be restricted to 10mg tablets in 24-tablet packs and renamed Busco-calm. Warnings advising patients to consult a doctor before first-time use or if symptoms worsen or do not improve over two weeks would be put on the packs.

The Medicines and Healthcare products Regulatory Agency is seeking comments on the consultation. These should be sent to Amanda Lawrence, Room 14-152, MHRA, Market Towers, 1 Nine Elms Lane, London SW8 5NQ (e-mail amanda.lawrence@mhra.gsi.gov.uk) by 13 August.