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.
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
1. WHAT BETACAP SCALP APPLICATION IS AND WHAT IT IS USED FOR
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VP8/24/1 202622
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
5. HOW TO STORE BETACAP SCALP APPLICATION
VP8/24/1 202622
When you can see that your scalp condition is getting better, you can start to apply Betacap Scalp Application less often, only once a day or even less. The frequency of application should be reduced to the minimum necessary to keep your scalp condition under control. For children (over one year old):
The active substance in Betacap Scalp Application is betamethasone valerate.
Medicines with the same active substance, strength and form include: Betnovate Lotion, Betnovate Scalp Application. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Betacap Scalp Application, 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.
For the topical treatment of dermatoses of the scalp, such as psoriasis and seborrhoeic dermatitis, which are unresponsive to less potent corticosteroids.
For adults, including the elderly, and children over the age of one year: Betacap Scalp Application should be applied sparingly to the scalp night and morning until improvement is noticeable. It may then be possible to sustain improvement by applying once a day, or less frequently.
For the treatment of seborrhoeic dermatitis in children, the product should not be used for longer than 5 to 7 days.
Not to be used where there is bacterial, fungal or viral infection of the scalp.
Not to be used in cases of sensitivity to any of the ingredients.
Not to be used in children under the age of one year.
Keep away from the eyes.
Betacap is highly flammable. Do not use near a fire or naked flame. Allow the treated scalp to dry naturally.
Long-term continuous topical therapy should be avoided where possible, particularly in infants and children, as adrenal suppression can occur even without occlusion. Complications sometimes associated with the use of topical corticosteroids in psoriasis include the possibility of rebound relapses, development of tolerance, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis, careful patient supervision is important.
Topical steroid withdrawal syndrome
Long term 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. It is more likely to occur when delicate skin sites such as the face and flexures are treated. 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.
The label will state strong steroid.
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.
For external use only.
None known.
There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.
None known.
Betamethasone valerate preparations are usually well tolerated, but if signs of hypersensitivity appear, application should be stopped immediately. As with other topical corticosteroids, 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 HPA axis. These effects are more likely to occur in infants and children, and if occlusive dressings are used. Local atrophy may occur after prolonged treatment, particularly under occlusion.
Adverse drug reactions are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
System Organ Class
Frequency
Adverse reaction
Immune System Disorders
Not known
Hypersensitivity
Endocrine Disorders
Not known
Hypothalamic-pituitary adrenal (HPA) axis suppression
Hypercorticism
Skin and Subcutaneous Tissue Disorders
Not known
Skin atrophy
Pustular psoriasis
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)
Eye disorders
Not known
Vision, blurred (see also section 4.4)
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 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 and in this situation treatment with Betacap Scalp Application should be discontinued.
Ask anything about Betacap Scalp Application. 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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