BETACAP SCALP APPLICATION

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.

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.

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. uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store.

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.

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.