Proposals to reclassify three prescription medicines as pharmacy medicines, and to extend the pharmacy sale of three other products, have been published by the Medicines Control Agency as consultation letter MLX 264. The three proposed POM-to-P changes are domperidone tablets, lodoxamide trometamol eye-drops and triamcinolone acetonide nasal spray.
It is proposed that domperidone 10mg tablets, with a maximum daily dose of 40mg and a maximum pack size of 10 tablets should be available for pharmacy sale in the same way as domperidone maleate tablets.
Also proposed for P sale are lodoxamide trometamol eye-drops to treat ocular signs and symptoms of allergic conjunctivitis in people aged over four years and triamcinolone acetonide nasal spray for the treatment of seasonal allergic rhinitis (packs would be restricted to 3.575mg of active ingredient with a maximum dose of 110mg per nostril per day and a maximum treatment period of three months).
The proposed extensions of pharmacy sale are for azelastine hydrochloride (to treat perennial allergic rhinitis, as well as the seasonal form), domperidone maleate (to increase the maximum pack size to 20 tablets) and paracetamol (to allow pharmacy sale of products with a maximum strength of 500mg and an authorised paediatric dose of from 120mg to 500mg).
The consultation letter also proposes the POM classification of 12 recently marketed ingredients which were POM because of marketing authorisation provisions.
They are cabergoline, cefprozil, indapamide, lansoprazole, lercanidipine hydrochloride, meloxicam, pantoprazole sodium, penciclovir, tamsulosin hydrochloride, ticlodipine hydrochloride, tiludronate disodium and toremifene.
Comments on the proposals can be sent to Mr Dugan Cummings, Room 1009a, MCA, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, by August 18.