The Medicines Control Agency has opened consultation on a proposal to make terbinafine 1 per cent cream a pharmacy medicine for the treatment of fungal infections.
Consultation letter MLX 259, issued on February 11, says that the Medicines Commission has advised that the cream can safely be used as a non-prescription medicine for the treatment of tinea pedis and tinea cruris. Pack sizes would be restricted to 15g. There would be ongoing monitoring to see if fungal resistance began to emerge.
A second proposal is to raise the maximum strength of ibuprofen for external use from 5 per cent to 10 per cent. The MCA takes the view that increasing the concentration of ibuprofen gel would not lead to an increase in ibuprofen dosage because people would use half as much product. The recommended maximum dose would be restricted to 125mg, with a maximum daily dose of 500mg. Pack sizes would be restricted to 100g.
Sixteen substances that have been classified as prescription medicines by provisions in their product licences are to be added to the Prescription Only Medicines (Human Use) Order 1997. They are eformoterol fumarate, imidapril hydrochloride, mirtazapine, moxonidine, omeprazole magnesium, ranitidine bismuth citrate, rimexolone, sertraline hydrochloride, sevoflurane, tazarotene and topiramate.
Comments can be sent to Mr Dugan Cummings, Room 1109a, Medicines Control Agency, 1 Nine Elms Lane, London SW8 5NQ, until March 24.