Bettamousse 1mg/g (0.1%) cutaneous foam

Bettamousse 1mg/g (0.1%) cutaneous foam

1 g of foam contains 1 mg betamethasone (0.1 %) as valerate

Excipients with known effect:

Cetyl Alcohol 1.10 % w/w, Stearyl alcohol 0.50 % w/w and Propylene glycol 2.00 % w/w

For a full list of excipients, see 6.1.

Cutaneous foam.

White, foam mousse.

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

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.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Bacterial, fungal, parasitic or viral infections of the scalp unless simultaneous treatment is initiated.

Dermatoses in children under six years of age.

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.

Bettamousse contains cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

Bettamousse contains propylene glycol, which may cause skin irritation.

Not relevant to topical use.

Pregnancy

There is no or limited data from the use of Betamethasone Valerate in pregnant women. Bettamousse should only be used in pregnancy if the potential benefit outweighs the risk.

Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development such as cleft palate, but the relevance of this in man is unknown. Reduced placental and birth weight have been recorded in animals and man after long-term treatment.

Breastfeeding

Bettamousse should only be used in lactation if the potential benefit outweighs the risk.

Betamethasone Valerate is excreted in maternal milk, a risk of therapeutic doses having an effect on new borns/infants cannot be excluded.

Fertility

None

Bettamousse has no known influence on the ability to drive and use machines.

The following side effects can occur with topical use of steroids:

They are ranked under headings of frequency using the following convention:

Very Common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very Rare (<1/10,000)]; Frequency not known (cannot be estimated from the available data)

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. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme on the MHRA website (www.mhra.gov.uk/yellowcard).

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.

Pharmacotherapeutic (ATC) code: DO7AC: Corticosteroids, dermatological preparations, potent (group III).

Betamethasone Valerate is a glucocorticosteroid which has topical anti-inflammatory activity.

Under conditions of normal use, topical administration of betamethasone Valerate is not associated with clinically significant systemic absorption.

Topical administration of corticosteroids to pregnant animals has been associated with abnormalities of foetal development and growth retardation, although the relevance of this in humans is unknown.

Cetyl alcohol

Stearyl alcohol

Polysorbate 60

Ethanol

Purified Water

Propylene glycol

Citric acid anhydrous

Potassium Citrate

Butane/Propane

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

2 years

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

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.

No special requirements.

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

RPH Pharmaceuticals AB

Lagervägen 7

136 50 Jordbro

Sweden

PL 36301/0036

19 April 1996/19 April 2001

26 September 2019