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Volume 461: debated on Monday 11 June 2007

To ask the Secretary of State for Health pursuant to the answer of 6 November 2006, Official Report, columns 775-6W, on methylphenidate, what progress has been made with updating the product information for methylphenidate to advise about serious cardiovascular adverse effects. (141744)

Following Europe-wide discussions, the product information for Concerta was revised in November 2006, to advise about serious cardiovascular adverse effects, and to recommend that methylphenidate should not be used in children or adolescents with known serious structural cardiac abnormalities. The product information for Ritalin was revised accordingly in June 2007, and the Medicines and Healthcare products Regulatory Agency is currently in discussion with the licence holder for Equasym.

Copies of the most up-to-date product information for Ritalin, Concerta and Equasym can be found in the Electronic Medicines Compendium available at This includes the patient information leaflet provided for patients with their medicines and summaries of product characteristics which provide information for doctors and pharmacists.