Medicinal Products

BETNEVAL 0.1%

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

Ointment
100 g tube
All forms

Indication

1. Preferred indications where local corticosteroid therapy is held for the best treatment:

· Contact eczema,

· atopic dermatitis,

· Lichenification.

2. Indications where local corticosteroid therapy is one of the usual treatments:

· Stasis dermatitis,

· Psoriasis (excluding extensive plaques),

· Lichen,

· Non-parasitic prurigo,

· Dyshidrosis,

· Sclero-atrophic genital lichen,

· Granuloma annulare,

· Discoid lupus erythematosus,

Palmoplantar amicrobial pustulosis

· Seborrheic dermatitis with the exception of the face,

· Symptomatic treatment of pruritus of fungus mycosis.

3. Indication of circumstances for a short period of time:

· Insect bites and parasitic prurigo after etiological treatment,

Note: Each dermatosis must be treated with a corticosteroid of the most appropriate level knowing that depending on the results we may be led to substitute a product of a stronger or less strong activity on all or part of the lesions.

The ointment form is suitable for dry, scaly lesions.

Dosage BETNEVAL 0, 1% Ointment Tube of 100 g

Treatment should be limited to one to two applications per day followed by a light massage. An excessive increase in the number of daily applications may aggravate the adverse effects without improving the therapeutic effects.

The treatment of large areas requires monitoring of the number of tubes used.

For a rational use, it is advisable to apply the product in spaced keys, then to spread it with a plastic glove until it is completely absorbed. Wash hands after application.

Some dermatoses (psoriasis, atopic dermatitis ...) make it desirable to stop gradually. It can be obtained by reducing the frequency of applications and / or by the use of a less strong or less dosed corticosteroid.

Against indications

· Hypersensitivity to any of the products contained in the preparation.

Primitive bacterial, viral, primitive or parasitic fungal infections even if they have an inflammatory component.

· Ulcerated lesions.

· Acne and rosacea.

· Application on the eyelids (risk of glaucoma).

Betneval side effects

The side effects listed below have been observed in trials. They are classified by organ class and frequency. Frequencies are defined: very common (≥1 / 10), frequent (≥ 1/100 and <1/10), uncommon (≥ 1/1000 and <1/100), rare (≥1 / 10 000 and <1/1000), very rare (<1 / 10, 000).

Frequency of spontaneous notification effects has not been attributed

Infections and infestations

Secondary infections

Not known : Secondary infections, especially under occlusive dressing or in folds, have been reported with local corticosteroids.

Immune system disorders

Not known : hypersensitivity: skin reactions including urticaria.

If signs of hypersensitivity occur, treatment should be discontinued immediately.

Endocrine disorders

Not known : possible systemic effects (see Warnings and precautions for use ).

Skin and subcutaneous tissue disorders

Common : Local burning sensation and pruritus.

Frequency not known : Prolonged use of corticosteroids with strong activity may result in skin atrophy, stretch marks (particularly at the roots of the limbs, and occurring more readily in adolescents), an ecchymotic purpura secondary to atrophy, a fragility of the skin, telangiectasia (to be feared especially on the face).

Acneiform or pustular eruptions, hypertrichosis, depigmentations have been reported.

Allergic contact dermatitis has also been reported with the use of local corticosteroids.

In the face, corticosteroids can create perioral dermatitis or aggravate rosacea (see sections Contraindications and Warnings and precautions for use ).

It may be observed delayed healing of unstressed wounds, pressure ulcers, leg ulcers (see section Contraindications ).

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