BETESIL MEDICATED PLASTER

Posology 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.

Paediatric population The safety and efficacy of BETESIL in children aged <18 years have not yet been established. Method of administration 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. 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. 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.

The commonly reported adverse reactions are skin and subcutaneous tissue disorders, occurring in about 15% of patients treated. These undesirable effects are mainly due to the pharmacological effects of the medicinal product. They are local effects on the skin in the plaster application area.

No systemic effects have been observed. The following list of adverse reactions has been observed during controlled clinical trials. Reported adverse reactions have been classified according to their frequency of observation using the following convention: very common (>1/10); common (>1/100, <1/10), uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000) and not known when cannot be estimated from the available data.

All cases reported were found to be common. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Other undesirable reactions not observed with BETESIL, but reported with topical corticosteroids are: contact dermatitis, hypersensitivity, oedema, purpura, striae atrophicae, dry skin, skin exfoliation, capillary fragility, skin irritation, hypertrichosis, hyperaesthesia, perioral dermatitis, burning or stretching sensation, folliculitis and skin hypopigmentation.

The use of topical corticosteroids on large areas of the body and for long periods, as well as the use of occlusive dressing can cause 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. 4). Hypersensitivity reactions to occlusive plastic material have been observed rarely.

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 the Google Play or Apple App Store.

In general, use of topical corticosteroids on large areas of the body and for prolonged periods, as well as the use of 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 of BETESIL 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). 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. 8 “Undesirable effects”). 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/or burning sensation, itch, skin peeling, oozing pustules 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 made with caution: a specialist advise is recommended and other treatment options should be considered, if appropriate.

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.

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).

1. Cutaneous tuberculosis and viral skin infections (including vaccinia pustules, herpes zoster and herpes simplex). 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.