Medicinal Products

BETESIL 2,25 mg

Generic drug of the therapeutic class: Dermatology
active ingredients: Betamethasone
laboratory: Genevrier

Medicated plaster
Box of 4 Sachets of 1
All forms

Indication

Treatment of inflammatory dermatoses that do not respond to corticosteroids with a lower level of activity, such as eczema, lichenification, lichen planus, granuloma annulare, palmar and plantar pustulosis, and mycosis fungoides.

Due to its special dosage form, BETESIL is suitable for the treatment of chronic plaque psoriasis, located in areas that are difficult to treat (knees, elbows and anterior tibia, on an area not exceeding 5% of body surface area).

Dosage BETESIL 2, 25 mg Medicated plaster Box of 4 Sachets of 1

Dosage

adults

Apply the medicated plaster once a day on the surface to be treated. Do not exceed the maximum daily dose of six medicated plasters and a treatment duration of 30 days maximum.

A new medicated plaster should be applied every 24 hours. It is also advisable to wait at least 30 minutes between one application and the next.

When a noticeable improvement is obtained, you can stop the applications and continue treatment with a corticosteroid of lower activity level.

children

The safety and efficacy of this specialty have not been demonstrated in children; in the absence of sufficient data, the use of BETESIL should be limited to adults.

Instruction for use

Clean and carefully dry the surface to be treated before each application so that the medicated plaster adheres well to the skin.

Open the envelope containing the medicated plaster and cut the plaster if necessary, so that it corresponds to the surface to be treated. Remove the protective film and apply the adhesive part of the plaster to the affected area.

Any unused portion of the plaster must be returned to the envelope for preservation and can be used in the next application (see section on Shelf Life ).

Medicated plaster should not be removed and reused.

When the plaster is applied, the skin should not be wet. It is advisable to bathe or shower between applications.

On the other hand, if the medicated plaster is applied to particularly moving surfaces (elbow or knee) and the edges begin to peel off, it is advisable to apply a small piece of adhesive bandage to the loose parts only.

Never cover the medicated plaster completely with occlusive material or compress.

Against indications

Hypersensitivity to the active substance or to any of the excipients.

Tuberculosis of the skin and viral skin infections (including vaccine pustules, herpes zoster and herpes simplex). Oozing lesions and primary skin lesions caused by fungal or bacterial infections. Acne, rosacea, perioral dermatitis, skin ulcers, burns and frostbite.

Do not apply on the face.

Do not use in patients under 18 years.

Betesil side effects

Common side effects are skin and subcutaneous tissue disorders occurring in approximately 15% of treated patients. These adverse effects are mainly due to the pharmacological effects of the product. These are local cutaneous effects at the application site of the medicinal plaster. No systemic effects were observed.

The list of adverse reactions below has been observed in controlled clinical studies.

Cases of adverse reactions reported were classified by frequency of occurrence according to the following convention: very common (≥1 / 10); frequent (≥1 / 100, ≤1 / 10); uncommon (≥1 / 1, 000, ≤1 / 100); rare (≥1 / 10, 000, ≤1 / 1, 000); very rare (≤1 / 10, 000), including isolated cases.

All reported cases were frequent. Within each group frequency, adverse effects are presented in descending order of severity.

Skin and subcutaneous tissue disorders

Frequent

Cutaneous atrophy

telangiectasia

pustules

papules

Boil

Erythema

itching

Skin erosion

Other undesirable effects not observed with BETESIL, but reported with topical corticosteroids are: contact dermatitis, hypersensitivity, edema, purpura, stretch marks, dry skin, desquamation, capillary fragility, skin irritation, hypertrichoses, hyperesthesia, perior dermatitis. oral, burning or tugging, folliculitis and skin depigmentation.

The use of topical corticosteroids over extended body surface area and for prolonged periods, as well as the use of an occlusive dressing, may cause temporary suppression of the hypothalamic-pituitary axis, leading to secondary hypoadrenalism and hypercorticism. adrenal including Cushing's syndrome. In these situations, treatment should be stopped gradually and under strict medical supervision because of the risk of acute adrenal insufficiency.

Sudden discontinuation of treatment in psoriatic patients may also lead to exacerbation of symptoms or generalized psor- sis psoriasis (see Warnings and Precautions section ).

Cases of hypersensitivity to occlusive plastic material have been rarely observed.

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