DIPROSONE

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

· contact eczema

· atopic dermatitis

· lichenification

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

· stasis dermatitis

· psoriasis (excluding very extensive plaques)

· lichen

· non-parasitic prurigo

· dyshidrosis

· genital lichen sclerosus-atrophicus

· granuloma annulare

· discoid lupus erythematosus

· seborrheic dermatitis except for the face

· symptomatic treatment of pruritus in mycosis fungoides

3. Situational indications for a short duration:

· insect bites and parasitic prurigo after etiological treatment.

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

Note: each dermatosis must be treated with a corticosteroid of the most appropriate level, keeping in mind that depending on the results, one may be led to substitute it with a product of stronger or weaker activity on all or part of the lesions.

Given the local use of this product: At the recommended doses, betamethasone for topical use is not likely to cause medically significant drug interactions.

Pregnancy

No teratogenicity studies have been conducted with local corticosteroids.

Nevertheless, studies concerning oral corticosteroid intake have not demonstrated a malformation risk higher than that observed in the general population.

Breastfeeding

During oral treatment, breastfeeding is to be avoided because corticosteroids are excreted in breast milk.

By local route, transdermal passage and therefore the risk of corticosteroid excretion in milk will be a function of the treated surface area, the degree of epidermal alteration and the duration of treatment.

Not applicable.

Prolonged use of high-potency corticosteroids may lead to skin atrophy, telangiectasias (to be particularly feared on the face), striae (notably at the root of the limbs, and occurring more readily in adolescents), ecchymotic purpura secondary to atrophy, and skin fragility.

On the face, corticosteroids may create perioral dermatitis or aggravate rosacea (see sections 4.4 and 4.3).

A delay in the healing of atonic wounds, pressure sores, and leg ulcers may be observed (see section 4.3).

Possibility of systemic effects (see section 4.4).

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

Secondary infections, particularly under occlusive dressings or in skin folds, and allergic contact dermatoses have also been reported during the use of topical corticosteroids.

Blurred vision (see also section 4.4) has been reported with the use of corticosteroids (frequency unknown).

Reporting of suspected adverse effects

Reporting of suspected adverse effects after medicinal product authorisation is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals report any suspected adverse effect via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centres - Website: www.signalement-sante.gouv.fr .