BETTAMOUSSE 1 mg/g Cutaneous Foam

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BETAMETHASONE VALERATE

Available from:

B & S Healthcare

ATC code:

D07AC01

INN (International Name):

BETAMETHASONE VALERATE

Dosage:

1 mg/g

Pharmaceutical form:

Cutaneous Foam

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Corticosteroids, potent (group III)

Authorization status:

Authorised

Authorization date:

2007-01-12

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bettamousse 1 mg/g (0.1% w/w) Cutaneous Foam
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of foam contains 1 mg betamethasone (as valerate) equivalent to 0.1% w/w betamethasone.
Excipients: Cetyl alcohol
Stearyl alcohol
Propylene glycol (E1520)
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous foam
_Product imported from Italy:_
White, foam mousse
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Steroid responsive dermatoses of the scalp, such as psoriasis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults, the elderly and children (over the age of six years): No more than a "golf-ball" sized amount of mousse
(containing approximately 3.5mg betamethasone), or proportionately less for children, to be massaged into the affected
areas of the scalp twice daily (in the morning and evening) until the condition improves. If there is no improvement
after 7 days, treatment should be discontinued. Once the condition has improved, application is reduced to once a day
and after daily treatment it may be possible to maintain improvement by applying even less frequently. In children over
the age of 6 years, this product should not, in general, be used for longer than 5 to 7 days.
Patients should be advised to use the product sparingly.
4.3 CONTRAINDICATIONS
Bacterial, fungal, parasitic or viral infections of the scalp unless simultaneous treatment is initiated.
Hypersensitivity to any component of the preparation.
Dermatoses in children under six years of age.
IRISH MEDICINES BOARD
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_Date Printed 28/02/2012_
_CRN 2108365_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid cont