Medicinal Products

BETAMETHASONE BIOGARAN 005%

Generic drug of Diprosone
Therapeutic class: Dermatology
active ingredients: Betamethasone
laboratory: Biogaran

Cream
30 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;

· 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.

The cream form is more particularly intended for acute, oozing lesions.

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.

Posology BETAMETHASONE BIOGARAN 005% cream tube 30 g

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;

· 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.

The cream form is more particularly intended for acute, oozing lesions.

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.

Against indications

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

· Primitive bacterial, viral, fungal or parasitic infections;

Ulcerated lesions;

· Acne

· Rosacea;

· Application on the eyelids (risk of glaucoma).

Adverse effects Betamethasone Biogaran

Prolonged use of corticosteroids with strong activity may result in skin atrophy, telangiectasia (to be particularly feared on the face), stretch marks (at the root of the limbs in particular, and occurring more readily in adolescents), a secondary ecchymotic purpura to atrophy, skin fragility.

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

It can be observed a delay of healing of uninjured wounds, pressure ulcers, leg ulcers (see Contraindications section ).

Potential for systemic effects (see Warnings and Precautions for Use section ).

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

Secondary infections, especially under occlusive dressing or in folds and allergic contact dermatoses have also been reported when using local corticosteroids.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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