Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CALCIPOTRIOL HYDRATE
McDowell Pharmaceuticals
50 5 Milligram
Cream
2010-11-12
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dovonex 50 micrograms/g Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains 50 micrograms of calcipotriol (as the hydrate). Excipients: Contains cetostearyl alcohol For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Cream _Product imported from the UK_ Soft white cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dovonex Cream is indicated for the topical treatment of plaque psoriasis (psoriasis vulgaris). Dovonex cream may also be used in combination with topical corticosteroids. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS The cream should be applied to the affected area once to twice daily. Twice daily application of the cream is often preferred initially. Application of the cream can be reduced to once daily when appropriate. Maximum weekly dose should not exceed 100g. Dovonex Cream in combination with corticosteroids (e.g. administration of Dovonex in the morning and steroid in the evening) is effective and well tolerated. CHILDREN _Over 12 years_ Dovonex Cream should be applied to the affected area twice daily. Maximum weekly dose should not exceed 75g. _Aged 6 to 12 years_ Dovonex Cream should be applied to the affected area twice daily. Maximum weekly dose should not exceed 50g. _Under 6 years_ There is limited experience of the use of Dovonex Cream in this age group. A maximum safe dose has not been established. There is no experience of use of Dovonex in combination with other psoriasis therapies in children. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/11/2010_ _CRN 2087161_ _page number: 1_ 4.3 CONTRAINDICATIONS Known hypersensitivity to any of the ingredients. Du Read the complete document