DIPROSONE

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

· contact eczema

· atopic dermatitis

· lichenification.

2. Indications where local corticotherapy 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 ointment form is more particularly intended for dry or scaly lesions.

Note: Each dermatosis must be treated with a corticosteroid of the most appropriate level, knowing 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.

Special warnings

Prolonged use of strong activity corticosteroids on the face exposes to the occurrence of a cortico-induced dermatitis and paradoxically cortico-sensitive with rebound after each stop. A progressive withdrawal, which is particularly difficult, is then necessary.

Due to the passage of the corticosteroid into the general circulation, treatment over large areas or under occlusion, can lead to the systemic effects of general corticosteroid therapy, particularly in infants and young children. These consist of a cushinoid syndrome and a slowing of growth. These effects disappear upon stopping the treatment, but a sudden stop can be followed by acute adrenal insufficiency.

Precautions for use

DIPROSONE is not intended for ophthalmic use.

In infants, it is preferable to avoid strong activity corticosteroids, one must be particularly wary of spontaneous occlusion phenomena that can occur in folds or under diapers.

In case of bacterial or fungal infection of a cortico-sensitive dermatosis, the use of the corticosteroid must be preceded by a specific treatment.

If a local intolerance appears, the treatment must be interrupted and the cause must be sought.

Visual disturbances may appear during systemic or local corticosteroid therapy (notably by nasal, inhaled and intra-ocular routes). In case of blurred vision or the appearance of any other visual symptom appearing during corticosteroid therapy, an ophthalmological examination is required to search for visual disturbances, notably a cataract, a glaucoma, or a rarer lesion such as central serous chorioretinopathy, described with the administration of corticosteroids by systemic or local route.

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-activity 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 .