Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
CLOTRIMAZOLE CLOTRIMAZOLE
G & A Licensing Limited
CLOTRIMAZOLE CLOTRIMAZOLE
500 mg/2%w
Pessaries and Cream
Product not subject to medical prescription
Withdrawn
2013-02-27
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Canesten Combi Pessary & Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The pessary contains clotrimazole 500mg. Each gram of cream contains 20mg clotrimazole (equivalent to 2%w/w). Excipients: cetostearyl alcohol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pessary and vaginal cream. _Product imported from the UK:_ White, convex pessary marked ‘BAYER’ on one side and ‘MU’ on the other side. A white oil-in-water cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The pessary is recommended for the treatment of candidal vaginitis. The cream is recommended for the treatment of candidal vulvitis. It should be used as an adjunct to treatment of candidal vaginitis. The cream can also be used for treatment of the sexual partner’s penis to prevent re-infection. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The pessary should be inserted intravaginally, as high as possible, using the applicator provided. ADULTS: Insert one pessary, preferably at night. A second treatment may be carried out if necessary. Canesten pessaries need moisture in the vagina in order to dissolve completely, otherwise undissolved pieces of the pessary might crumble out of the vagina. Pieces of undissolved pessary may be noticed by women who experience vaginal dryness. To help prevent this it is important that the pessary is inserted as high as possible into the vagina at bedtime. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 25/10/2011_ _CRN 2106337_ _page number: 1_ To insert the pessary: GENERALLY: Treatment during the menstrual period should be avoided due to the risk of the pessary being washed out by the mestrual Lire le document complet