This information is intended for use by health professionals

1. Name of the medicinal product

Bettamousse 1mg/g (0.1%) cutaneous foam

2. Qualitative and quantitative composition

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.

3. Pharmaceutical form

Cutaneous foam.

White, foam mousse.

4. Clinical particulars
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.

4.3 Contraindications

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.

4.4 Special warnings and precautions for use

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.

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.

4.5 Interaction with other medicinal products and other forms of interaction

Not relevant to topical use.

4.6 Fertility, pregnancy and lactation

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

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

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)

System Organ Class

Frequency

Adverse Events

Infections and infestations

Uncommon

Secondary infection

Rare

Folliculitis

Immune system disorders

Rare

Hypersensitivity (steroid)

Endocrine disorders

Not known

Prolonged use of large amounts or treatment of extensive areas can result in sufficient systemic absorption to produce the features of hypercorticism and suppression of the hypothalamic-pituitary-adrenal axis. These effects are more likely to occur in children, and if occlusive dressings are used.

Psychiatric disorders

Not known

Individual cases of headache have been described.

Skin and subcutaneous disorders

Uncommon

Skin atrophy, stria distensae, Rosacea-like dermatitis (face), Ecchymoses.

Rare

Hypertrichosis, Hypo-/hyper-pigmentation, Telangiectases.

In rare instances, treatment of psoriasis with corticosteroids (or their withdrawal) is thought to have provoked the pustular form of the disease. (See Precautions).

Rarely, perioral dermatitis.

Not known

Individual cases of stinging and pruritus have been described. Other side effects include: purpura, acne (especially during prolonged application),

General disorders and administration site conditions

Rare

Systemic activity

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).

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.

5. Pharmacological properties
5.1 Pharmacodynamic properties

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

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

5.2 Pharmacokinetic properties

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

5.3 Preclinical safety data

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.

6. Pharmaceutical particulars
6.1 List of excipients

Cetyl alcohol

Stearyl alcohol

Polysorbate 60

Ethanol

Purified Water

Propylene glycol

Citric acid anhydrous

Potassium Citrate

Butane/Propane

6.2 Incompatibilities

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

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.

7. Marketing authorisation holder

RPH Pharmaceuticals AB,

Lagervägen 7,

136 50 Jordbro,

Sweden

8. Marketing authorisation number(s)

PL 36301/0036

9. Date of first authorisation/renewal of the authorisation

19 April 1996/19 April 2001

10. Date of revision of the text

06/07/2015