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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betnovate Scalp Application 0.1% w/w Cutaneous Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains betamethasone valerate equivalent to 0.1% w/w of betamethasone.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution
_Product imported from Greece:_
A colourless, hazy, slightly viscous liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Betamethasone valerate is a topical corticosteroid used in the management of steroid-responsive dermatoses of the
scalp, such as psoriasis, seborrhoea capitis and inflammation associated with severe dandruff.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
A small quantity of Betnovate Scalp Application should be applied to the scalp night and morning until improvement is
noticeable. It may then be possible to sustain improvement by applying once a day, or even less frequently.
4.3 CONTRAINDICATIONS
Use in the presence of untreated infections of bacterial, viral, tuberculous or fungal origin.
Hypersensitivity to the preparation.
Dermatoses in children under one year of age, including dermatitis and napkin eruptions.
Use in acne vulgaris, rosacea or in perioral dermatoses.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Prolonged use of uninterrupted occlusion (including napkin) or use with extensive occlusive dressings may suppress
adrenocortical function.
Continuous treatment for longer than three weeks on use of occlusion (including napkins) should be avoided in patients
under the age of three years because of the possibility of adrenocortical suppression or of growth suppression, systemic
absorption and hypercorticism.
Care must be taken to keep the preparation away from the eyes.
Do not use near a naked flame.
IRISH MEDICINES BOARD
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