DOVONEX 50 Micrograms/g Cream
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
05-06-2024
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Active ingredient:
CALCIPOTRIOL
Available from:
Clear Pharmacy
ATC code:
D05AX02
INN (International Name):
CALCIPOTRIOL
Dosage:
50 Micrograms/g
Pharmaceutical form:
Cream
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Other antipsoriatics for topical use
Authorization status:
Authorised
Authorization date:
2010-12-21
Summary of Product characteristics
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).
Excipient(s): Cetostearyl alcohol
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
_Product imported from 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.
4.3 CONTRAINDICATIONS
Known hypersensitivity to any of the ingredients. Due to the content of calcipotriol, Dovonex is contraindicated in
patients with known disorders of calcium metabolism.
IRISH MEDICINES BOARD
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