Revision Year: 2019 Publisher: IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia 2, 26900, Lodi
BETESIL is indicated in adults.
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.
Due to its particular pharmaceutical form, BETESIL is suitable for chronic plaque psoriasis localized in difficult to treat areas (e.g. knees, elbows and anterior face of the tibia on an area not greater than 5% of the body surface).
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. It is also advisable to wait at least 30 minutes between one application and the next.
Once an appreciable improvement has been obtained, you can discontinue the application and possibly continue the treatment with a less potent corticosteroid.
The safety and efficacy of BETESIL in children aged <18 years have not yet been established.
Precautions to be taken before handling or administering the medicinal product Cleanse and carefully dry the area to be treated before each application so that the medicated plaster adheres well to the skin.
Open the sachet containing the medicated plaster and cut the plaster, if necessary, so that it fits the area to be treated. Peel off the protective film and apply the adhesive medicated part to the area concerned.
Any unused part of the plaster should be put back into the sachet so that it keeps and can be used at the next application (see section 6.3).
The medicated plaster must not be removed and reused.
Once the medicated plaster has been applied, the skin must not come in contact with water. It is advisable to take a bath or have a shower between applications.
Furthermore, if the medicated plaster is applied to particularly mobile parts (e.g. an elbow or knee) and its edges start to lift, it is advisable to apply the adhesive strips for securing dressings included in the medicinal product pack.
Never cover the medicated plaster completely with occlusive material or dressing.
No case of overdose has been reported.
Due to the product characteristics and the route of administration, the occurrence of symptoms and signs of corticosteroid overdose is unlikely.
However, prolonged use of topical corticosteroids may cause the temporary suppression of the hypothalamus-pituitary-adrenal axis, leading to secondary hypoadrenalism. Adrenal hypercorticism symptoms spontaneously reverse and their treatment is symptomatic. If necessary, act to restore the hydroelectrolytic balance. In the event of chronic toxicity, remove the corticosteroid from the organism slowly.
3 years.
After opening the sachet: 1 month.
Do not store above 25°C.
Store the medicated plaster in its original sachet in order to preserve its integrity.
For storage conditions after first opening of the medicinal product, see section 6.3.
Boxes: 4 medicated plasters / 8 medicated plasters / 16 medicated plasters
Each medicated plaster is packed individually in a paper/polyethylene/aluminium/ethylenemethacrylic acid copolymer sachet.
Each box includes adhesive strips for securing dressings (medical device).
Not all pack sizes may be marketed.
Used medicated plasters must not be flushed down toilets.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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