BETTAMOUSSE Cutaneous foam Ref.[49930] Active ingredients: Betamethasone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: RPH Pharmaceuticals AB, Box 603, 101 32 Stockholm, Sweden

4.1. Therapeutic indications

Bettamousse is indicated for steroid responsive dermatoses of the scalp, such as psoriasis.

4.2. Posology and method of administration

Posology

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 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.

Paediatric population

In children over the age of 6 years, this product should not, in general, be used for longer than 5 to 7 days.

Method of administration

To be massaged into the affected areas of the scalp. Patients should be advised to use the product sparingly.

4.9. Overdose

Acute overdosage is very unlikely to occur. However, in the case of chronic overdosage or misuse, the features of hypercorticism may appear. In this situation topical steroids should be discontinued under careful clinical supervision, with supportive therapy if appropriate.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

Do not store above 25°C. Do not refrigerate.

6.5. Nature and contents of container

Pressurised container.

Aluminium EP-lined Cebal can with Precision valve and clear cover cap, with a net weight of 50 or 100g.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.

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