Abbreviated Prescribing Information for BETESIL 2.250 mg medicated plaster.
Please refer to the full Summary of Product Characteristics (SmPC) prior to prescribing.
Presentation: A colourless, medicated plaster, containing 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone). Indications: Indicated in adults for the treatment of inflammatory skin disorders which do not respond to treatment with less potent corticosteroids, such as eczema, lichenification, lichen planus, granuloma annulare, palmoplantar pustulosis and mycosis fungoides. Also suitable for chronic plaque psoriasis localized in difficult to treat areas (e.g., knees, elbows, and anterior face of the tibia). Overall, the surface area treated with BETESIL should not exceed 5% of the body surface). Dosage and Administration: Apply the medicated plaster to the skin area to be treated once a day. Do not exceed the maximum daily dose of six medicated plasters and the maximum treatment period of 30 days. A new medicated plaster must be applied every 24 hours. Wait at least 30 minutes between one application and the next. Once an appreciable improvement has been obtained, discontinue application and consider continuing treatment with a less potent corticosteroid. The safety and efficacy in children aged <18 years has not yet been established. For full details of usage please refer to the relevant section of the SmPC. Contraindications: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Cutaneous tuberculosis and viral skin infections (including vaccinia pustules, herpes zoster and herpes simplex). Exudative lesions and primary skin infections caused by fungi or bacteria (e.g. syphilitic skin lesions). Acne, acne rosacea, perioral dermatitis, skin ulcers, burns and frostbite. Do not apply to face. Do not use on patients under 18 years of age. Precautions and Warnings: Caution in patients with visual disturbance. Cataract, glaucoma or rare diseases such as central serous chorioretinopathy have been reported with systemic and topical corticosteroid use. Use of topical corticosteroids on large areas of the body and for prolonged periods, as well as the use of an occlusive dressing can cause a temporary suppression of the hypothalamus-pituitary-adrenal axis, leading to secondary hypoadrenalism and adrenal hypercorticism, including the Cushing’s syndrome. In these situations, treatment should be discontinued gradually and under strict control of a doctor due to the risk of acute adrenal insufficiency. Sudden withdrawal of the treatment in psoriatic patients, may also lead to symptoms exacerbation or generalized pustular psoriasis. Prolonged use in diffuse psoriasis (except for the treatment of isolated plaques) or diffuse eczema or application on lesions located in skin folds is not recommended, as these conditions may increase systemic absorption. The use of occlusive bandages, especially with plastic material, may increase this effect. The symptoms of this are: facial redness, weight changes (fat increase in body and face and loss in legs and arms), reddish streaks on stomach, headache, menstrual alterations, or an increase in unwanted face and body hair. In this regard, it is known that certain skin areas (face, eyelids, armpits, scalp and scrotum) absorb more easily than others (skin on the knees, elbows, palms of the hands and feet on soles). Long term continuous or inappropriate use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). Application of topical medicinal products, especially if prolonged, may give rise to hypersensitivity reaction. Skin atrophy has also been reported after three-week treatment periods. In case of drug intolerance, for example if skin irritation or contact dermatitis occurs during treatment, it is necessary to stop the medicated plaster application and start suitable treatment (see section 4.8 of the SmPC, “Undesirable effects”). Corticosteroids may affect the results of the nitroblue tetrazolium test (NBT) for diagnosing bacterial infections by producing false negatives. Medicinal products containing corticosteroids must be used with caution in patients with impaired immune system function (T-lymphocytes) or in those being treated with immunosuppressive therapy. The product contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause hypersensitivity reactions (possibly delayed). There are no or limited amount of data from the use of betamethasone valerate in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Betesil is not recommended during pregnancy and in women of childbearing potential not using contraception. Undesirable effects: Commonly reported side effects are skin and subcutaneous tissue disorders, occurring in about 15% of patients treated. All cases reported during controlled clinical trials were found to be common (≥1/100, <1/10): skin atrophy, telangiectasia, pustules, papules, furuncle, erythema, pruritus, skin erosion. These undesirable effects are local effects on the skin in the plaster application area. The frequency of withdrawal syndrome is not known. No systemic effects have been observed. Prescribers should consult the summary of product characteristics for other more general considerations on side effects reported with use of corticosteroids for cutaneous use. Precautions for Storage: Do not store above 25°C. Store the medicated plaster in its original sachet to preserve its integrity. For storage conditions after first opening of the medicinal product, see SmPC. Legal Category: POM. Package Quantities: A carton containing four or eight envelopes, each envelope contains one 7.5 cm x 10 cm medicated plaster containing 2.250 mg of betamethasone valerate. Marketing Authorisation Number and Holder: PL 21039/0009. IBSA FARMACEUTICI ITALIA S.R.L. VIA MARTIRI DI CEFALONIA 2 LODI -26900 ITALY. Basic NHS Price: £13.98 per pack of four BETESIL® 2.250 mg medicated plasters. £27.46 per pack for eight BETESIL® 2.250 mg medicated plasters. Date of preparation of Prescribing Information: November 2023. Further information can be found in the Summary of Product Characteristics or from: Derma UK Ltd, The Toffee Factory, Lower Steenbergs Yard, Quayside, Ouseburn, Walker Rd, Newcastle upon Tyne, Tyne and Wear, NE1 2DF.