Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: RPH Pharmaceuticals AB, Box 603, 101 32 Stockholm, Sweden
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 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.
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.
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.
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).
| 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. |
| Eye disorders | Not known | Vision, blurred (see also Section 4.4) |
| 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 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 the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
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