BETTAMOUSSE

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 For topical use. Note: for proper dispensing of foam, the container should be held upside down and the actuator depressed.

The patient or carer should shake the can well before use, remove the cap, invert the can and dispense required amount of mousse onto a clean saucer or something similar. Dispensing directly onto hands should be avoided as the mousse will begin to melt when it touches skin.

The product is to be massaged sparingly into the affected areas of the scalp. It is recommended to wash hands immediately after use. Hair should not be washed immediately after use, allowing the mousse to work overnight or through the day.

g. 4) Common Pruritus, local skin burning/skin pain Very rare Allergic contact dermatitis /dermatitis, erythema, rash, urticaria, pustular psoriasis, skin thinning* / skin atrophy*, skin wrinkling*, skin dryness*, striae*, telangiectasias*, pigmentation changes*, hypertrichosis, exacerbation of underlying symptoms *Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA) axis suppression.

Skin and subcutaneous disorders Not known Withdrawal reactions - redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules. 4) General disorders and administration site conditions Very Rare Application site irritation/pain If signs of hypersensitivity appear, application should be stopped immediately.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Avoid contact with the eyes, open wounds and mucosae. Do not use near a naked flame. The least amount of mousse required to control the disease should be used for the shortest possible time. This should minimise the potential for long term side effects.

This is particularly the case in children, as adrenal suppression can occur even without its use with an occlusive dressing. As with other topical corticosteroids, at least monthly clinical review is recommended if treatment is prolonged, and it may be advisable to monitor for signs of systemic activity.

The use of topical corticosteroids in psoriasis requires careful supervision. Glucocorticoids can mask, activate and worsen a skin infection. Development of secondary infection requires appropriate antimicrobial therapy and may necessitate withdrawal of topical corticosteroid therapy.

Occlusive treatment should be avoided when there are signs of secondary infection. There is a risk of the development of generalised pustular psoriasis or local or systemic toxicity due to impaired barrier function of the skin. Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use.

If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Tolerance may develop and rebound relapse may occur on withdrawal of treatment. Long term continuous or inappropriate use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome).

A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected.

Reapplication should be with caution and specialist advice is recommended in these cases or other treatment options should be considered. g. contact dermatitis). This medicine contains 2022 mg alcohol (ethanol) in each “golf-ball” sized amount of mousse (approx.

79% w/w. It may cause burning sensation on damaged skin. g. hairdryers). This medicine contains 70 mg of propylene glycol in each “golf-ball” sized amount of mousse (approx. 5g) which is equivalent to 2% w/w.

1. Bacterial, fungal, parasitic or viral infections of the scalp unless simultaneous treatment is initiated. Dermatoses in children under six years of age.