Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Betamethasone valerate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for
Bettamousse contains the active substance betamethasone as valerate. Bettamousse belongs to a group of medicines called corticosteroids ('steroids' for short). Bettamousse is used to treat skin disorders of the scalp such as psoriasis (raised red patches of skin covered in silvery scales) that may feel itchy, tight or sore. Bettamousse works by reducing inflammation (redness, itching and soreness). It is important to use this medicine to prevent damage to the skin and infections from developing. Corticosteroid creams, ointments and other topical preparations come in four different strengths. These are known as mild, moderately potent, potent or very potent. Healthcare professionals will usually refer to topical corticosteroid potency rather than strength. A potent corticosteroid has a much stronger effect than a mild corticosteroid. The percentage of active ingredient that is sometimes included on product packaging does not indicate potency. Betamethasone is classed as a potent corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition. 2.
e Bettamousse
Do not use Bettamousse: If you are allergic to betamethasone valerate or any of the other ingredients of this medicine (listed in section 6). If you have any kind of infection of the scalp, unless this is already being treated On a child under 6 years of age. If any of the above applies to you, talk to your doctor or pharmacist. Warnings and precautions Talk to your doctor or pharmacist before using Bettamousse if: You have any kind of skin infection You have open wounds on your scalp You experience blurred vision or any other visual disturbances Contact your doctor if you experience blurred vision or other visual disturbances.
If there is a worsening of your condition during use consult your prescriber – you may be experiencing an allergic reaction, have an infection or your condition requires a different treatment. If you experience a recurrence of your condition shortly after stopping treatment, within 2 weeks, do not restart using the foam without consulting your prescriber unless your prescriber has previously advised you to do so. If your condition has resolved and on recurrence the redness extends beyond the initial treatment area and you experience a burning sensation, please seek medical advice before restarting treatment. Children and adolescents Do not give this medicine to children under the age of 6 years.
Other medicines and Bettamousse Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines may affect how Bettamousse works or make it more likely you will have side effects. Examples of these medicines include:
Bettamousse
Always use this medicine exactly as your doctor or pharmacist has told you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. Check with your doctor or pharmacist if you are not sure. Remember: –
Use as little Bettamousse as possible for the shortest possible time Avoid contact with your eyes. If Bettamousse gets into your eyes, rinse well with cold water. If your eyes continue to sting, contact your doctor Avoid contact with the inside of your nose and mouth Avoid contact with any open wounds.
The recommended dose is Adults: No more than a golfball sized amount of mousse Massage into the affected areas of the scalp twice a day (in the morning and evening) If there is no improvement in your condition after 7 days, stop using Bettamousse and see your doctor again. Use in children over 6 years of age: The dose depends on their physical size The usual dose for children is less than for adults. For example, for a child half the size of an adult, use no more than half a golf ball sized amount of mousse Massage into the affected area of the scalp twice a day (in the morning and evening) Do not use Bettamousse for more than 5 to 7 days on children. If the symptoms have not improved see your doctor again Do not use in children under 6 years of age As symptoms improve For adults and children: Where there is some improvement in symptoms, Bettamousse can be applied just once a day. If the condition continues to get better, it may be possible to apply Bettamousse once every few days, to keep the symptoms from coming back. Infections If you have a skin infection your doctor will give you another medicine to treat the infection Whilst you have an infection, your doctor may tell you to stop using Bettamousse. If you are not sure about how much mousse to use, ask your doctor or pharmacist. Instructions for use: Attention: for proper dispensing of foam, it is important to hold the container upside down! 1. Shake the can well before use.
2. Remove the cap.
3. Turn the can upside down and squirt the required amount of mousse onto a clean saucer or something similar. The mousse melts when it touches your skin, so do not squirt it into your hand.
4. Massage the mousse into the affected areas of your scalp, and not your hair. Allow your hair to dry naturally.
5. Wash your hands immediately after using the mousse.
6. Do not wash your hair straight after applying the mousse. Let the mousse work overnight or through the day.
7. You can wash and dry your hair immediately before applying the mousse. This product is flammable. Do not use Bettamousse near a naked flame or direct source of heat. Do not smoke while using or holding the can. Medical check-ups If you use this medicine for a long period of time, your doctor may ask you to have check-ups. These are to make sure that your medicine is working properly and that the dose you are taking is right for you. If you use more Bettamousse than you should Wash your scalp straight away and start again. It is unlikely that you will suffer side-effects from using too much on one occasion. If you are concerned, contact the nearest hospital casualty department or your doctor. Using more than the recommended dose of Bettamousse for a long time can lead to a number of side effects (see section 4). If you forget to use Bettamousse
Do not use a double dose to make up for a forgotten dose. Simply take the next dose as planned. If you stop using Bettamousse Do not stop using Bettamousse without first talking to your doctor. Your condition may return after you stop using Bettamousse. If this happens, talk to your doctor as soon as possible. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.
Like all medicines Bettamousse can cause side effects, although not everybody gets them. Stop using Bettamousse and tell your doctor as soon as possible if:
Not Known: frequency cannot be estimated from the available data
Bettamousse
Keep this medicine out of the sight and reach of children. Do not use Bettamousse after the expiry date on the label. The expiry date refers to the last day of that month. Do not store above 25°C. Do not refrigerate. Store upright. Protect from sunlight and any other sources of direct heat as this product is very flammable. Do not pierce or burn the can, even when empty. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.
What Bettamousse contains The active substance is betamethasone (as valerate) 1 mg/g (0.1%). The other ingredients are cetyl alcohol, stearyl alcohol, polysorbate 60, ethanol anhydrous, purified water, propylene glycol (E1520), citric acid anhydrous, potassium citrate, and butane/propane. What Bettamousse looks like and contents of the pack Bettamousse is a white cutaneous foam mousse. Bettamousse comes in an aluminium can with a valve and a clear cap. It comes in two sizes, 50 g or 100 g. Not all pack sizes may be marketed. Marketing Authorisation Holder RPH Pharmaceuticals AB Box 603 101 32 Stockholm Sweden Manufacturers Farmol Health Care S.r.l. Via del Maglio, 6 23868 Valmadrera (Lecco)
Italy Recipharm Uppsala AB Björkgatan 30 SE-751 82 Uppsala Sweden If this leaflet is difficult to see or read or you would like it in a different format, please contact: RPH Pharmaceuticals AB, Box 603, 101 32 Stockholm, Sweden This leaflet was last revised 09/2023.
The active substance in Bettamousse 1mg/g (0.1%) cutaneous foam is betamethasone valerate.
This leaflet reproduces the patient information leaflet approved for Bettamousse 1mg/g (0.1%) cutaneous foam, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
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
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.
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. 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.
Excipients
This medicine contains cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
This medicine contains 2022 mg alcohol (ethanol) in each “golf-ball” sized amount of mousse (approx. 3.5g), which is equivalent to 57.79% w/w. It may cause burning sensation on damaged skin. Do not use near an open flame, lit cigarette or some devices (e.g. hairdryers).
This medicine contains 70 mg of propylene glycol in each “golf-ball” sized amount of mousse (approx. 3.5g) which is equivalent to 2% w/w.
Co-administered drugs that can inhibit CYP3A4 (e.g. ritonavir and itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure. The extent to which this interaction is clinically relevant depends on the dose and route of administration of the corticosteroids and the potency of the CYP3A4 inhibitor.
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)
System Organ Class
Frequency
Adverse Events
Infections and infestations
Very rare
Opportunistic infection
Immune system disorders
Very rare
Local hypersensitivity
Endocrine disorders
Very rare
Hypothalamic-pituitary adrenal (HPA) axis suppression Cushingoid features (e.g. moon face, central obesity), delayed weight gain/growth retardation in children, osteoporosis, glaucoma, hyperglycaemia/glucosuria, cataract, hypertension, increased weight/obesity, decreased endogenous cortisol levels, alopecia, trichorrhexis
Eye disorders
Not known
Vision, blurred (see also Section 4.4)
Skin and subcutaneous disorders
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.
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. (see section 4.4)
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. 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.
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.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Bettamousse 1mg/g (0.1%) cutaneous foam. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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