Page 11 - Betesil-12pp-V3

Abbreviated Prescribing Information for
BETESIL 2.250 mg medicated plaster
®

Abbreviated Prescribing Information for BETESIL 2.250 knees, elbows, palms of the hands and feet on soles). Application
®
mg medicated plaster. Please refer to the full Summary of of topical medicinal products, especially if prolonged, may give rise
Product Characteristics (SmPC) prior to prescribing. to hypersensitivity reaction. Skin atrophy has also been reported
Presentation: A colourless, medicated plaster, containing after three-week treatment periods. In case of drug intolerance,
2.250 mg of betamethasone valerate (corresponding to 1.845 for example if skin irritation or contact dermatitis occurs during
mg of betamethasone). Indications: Indicated in adults for the treatment, it is necessary to stop the medicated plaster application
treatment of inflammatory skin disorders which do not respond and start suitable treatment (see section 4.8 of the SmPC,
to treatment with less potent corticosteroids, such as eczema, “Undesirable effects”). Corticosteroids may affect the results of the
lichenification, lichen planus, granuloma annulare, palmoplantar nitroblue tetrazolium test (NBT) for diagnosing bacterial infections
pustulosis and mycosis fungoides. Also suitable for chronic by producing false negatives. Medicinal products containing
plaque psoriasis localized in difficult to treat areas (e.g., knees, corticosteroids must be used with caution in patients with impaired
elbows, and anterior face of the tibia). Overall, the surface area immune system function (T-lymphocytes) or in those being treated
treated with BETESIL should not exceed 5% of the body surface). with immunosuppressive therapy. The product contains methyl
Dosage and Administration: Apply the medicated plaster parahydroxybenzoate and propyl parahydroxybenzoate, which may
to the skin area to be treated once a day. Do not exceed the cause hypersensitivity reactions (possibly delayed). There are no
maximum daily dose of six medicated plasters and the maximum or limited amount of data from the use of betamethasone valerate
treatment period of 30 days. A new medicated plaster must be in pregnant women. Studies in animals have shown reproductive
applied every 24 hours. Wait at least 30 minutes between one toxicity (see section 5.3). Betesil is not recommended during
application and the next. Once an appreciable improvement has pregnancy and in women of childbearing potential not using
been obtained, discontinue application, and consider continuing contraception. Undesirable effects: Commonly reported side
treatment with a less potent corticosteroid. The safety and efficacy effects are skin and subcutaneous tissue disorders, occurring in
in children aged <18 years has not yet been established. For about 15% of patients treated. All cases reported during controlled
full details of usage please refer to the relevant section of the clinical trials were found to be common (≥1/100, <1/10): skin
SmPC. Contraindications: Hypersensitivity to the active substance atrophy, telangiectasia, pustules, papules, furuncle, erythema,
or to any of the excipients listed in section 6.1. Cutaneous pruritus, skin erosion. These undesirable effects are local effects
tuberculosis and viral skin infections (including vaccinia pustules, on the skin in the plaster application area. No systemic effects
herpes zoster and herpes simplex). Exudative lesions and primary have been observed. Prescribers should consult the summary of
skin infections caused by fungi or bacteria (e.g. syphilitic skin product characteristics for other more general considerations on
lesions). Acne, acne rosacea, perioral dermatitis, skin ulcers, burns side effects reported with use of corticosteroids for cutaneous
and frostbite. Do not apply to face. Do not use on patients under 18 use. Precautions for Storage: Do not store above 25°C. Store
years of age. Precautions and Warnings: Caution in patients with the medicated plaster in its original sachet to preserve its integrity.
visual disturbance. Cataract, glaucoma, or rare diseases such as For storage conditions after first opening of the medicinal product,
central serous chorioretinopathy have been reported with systemic see SmPC. Legal Category: POM. Package Quantities: A
and topical corticosteroid use. Use of topical corticosteroids on carton containing four or eight envelopes, each envelope contains
large areas of the body and for prolonged periods, as well as the one 7.5 cm x 10 cm medicated plaster containing 2.250 mg of
use of an occlusive dressing can cause a temporary suppression betamethasone valerate. Marketing Authorisation Number
of the hypothalamus-pituitary-adrenal axis, leading to secondary and Holder: PL 21039/0009. IBSA FARMACEUTICI ITALIA
hypoadrenalism and adrenal hypercorticism, including the S.R.L. VIA MARTIRI DI CEFALONIA 2 LODI -26900 ITALY. Basic
Cushing’s syndrome. In these situations, treatment should be NHS Price: £13.98 per pack of four BETESIL 2.250 mg
®
discontinued gradually and under strict control of a doctor due medicated plasters. £27.46 per pack for eight BETESIL 2.250
®
to the risk of acute adrenal insufficiency. Sudden withdrawal of mg medicated plasters. Date of preparation of Prescribing
the treatment in psoriatic patients, may also lead to symptoms Information: December 2021.
exacerbation or generalized pustular psoriasis. Prolonged use in Further information can be found in the Summary of Product
diffuse psoriasis (except for the treatment of isolated plaques) or Characteristics or from: Derma UK Ltd, The Toffee Factory, Lower
diffuse eczema or application on lesions located in skin folds is Steenbergs Yard, Quayside, Ouseburn, Walker Rd, Newcastle upon
not recommended, as these conditions may increase systemic Tyne, Tyne and Wear, NE1 2DF.
absorption. The use of occlusive bandages, especially with plastic
material, may increase this effect. The symptoms of this are: facial Adverse events should be reported.
redness, weight changes (fat increase in body and face and loss in Information about adverse event reporting can be
legs and arms), reddish streaks on stomach, headache, menstrual found at www.mhra.gov.uk/yellowcard.
alterations, or an increase in unwanted face and body hair. In this Adverse events should also be reported to
regard, it is known that certain skin areas (face, eyelids, armpits, Derma UK Ltd, UK on 0191 375 9020.
scalp and scrotum) absorb more easily than others (skin on the

2.250 mg medicated plaster
Betamethasone valerate