BETNEVAL 0.1 %

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

· contact eczema,

· atopic dermatitis.

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,

· granuloma annulare,

· discoid lupus erythematosus,

· non-microbial palmoplantar pustulosis,

· 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 suitable for dry, 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.

Metabolic disorders such as decreased glucose tolerance are observed during the concomitant use of local corticosteroids and antidiabetic drugs. Warn the patient and reinforce self-monitoring of blood and urine glucose, especially at the beginning of treatment.

Pregnancy

Studies conducted in animals via systemic administration have shown a teratogenic effect. However, a large number of pregnancies (more than 1000 pregnancies) exposed to corticosteroids via systemic administration have shown no malformative or toxic effect of betamethasone valerate for the foetus or the newborn. Therefore, the use of BETNEVAL may be considered during pregnancy if necessary.

Breastfeeding

Corticosteroids pass into breast milk after systemic administration. Via local administration, 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.

Therefore, given topical use, the application of BETNEVAL is possible during breastfeeding.

Prolonged contact of the infant with the treated skin area of the mother should be avoided.

In case of application on the breasts, the skin should be cleaned before each feeding to avoid any accidental ingestion by the infant.

Fertility

After prenatal exposure to betamethasone valerate via intramuscular administration, a decrease in sperm quality, plasma testosterone levels and fertility has been observed in the male rat. The clinical relevance of these results is not clearly established and is difficult to extrapolate to the cutaneous route.

No study evaluating the effect of betamethasone valerate on the ability to drive vehicles or use machines has been performed. A harmful effect on these activities cannot be anticipated based on the known side effect profile of topical betamethasone valerate.

Adverse effects are listed below according to the MedDRA organ system classification and according to their frequency. The frequencies are as follows: very frequent (≥ 1/10), frequent (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000) and unknown frequency (cannot be estimated on the basis of available data).

Infections and infestations

Unknown frequency: secondary infections particularly under occlusive dressings or in folds and allergic contact dermatoses have been reported during the use of local corticosteroids.

Immune system disorders

Unknown frequency: local hypersensitivity

Endocrine disorders

Unknown frequency:

Adrenal insufficiency upon abrupt discontinuation of treatment due to suppression of the hypothalamo-hypophyso-adrenal axis.

Cushingoid syndrome (which presents notably by a moon face, central obesity) and whose skin disorders are: skin atrophy, thinning of the skin, skin dryness, stretch marks, telangiectasias.

Skin and subcutaneous tissue disorders

Frequent: pruritus, local skin burning

Unknown frequency:

Pigmentation changes, hypertrichosis, allergic contact dermatitis / dermatitis, pustular psoriasis, erythema, skin eruptions, urticaria.

Prolonged use of high-potency topical corticosteroids may lead to ecchymotic purpura secondary to skin atrophy as well as skin fragility.

Allergic contact dermatitides have also been reported during the use of local corticosteroids. In case of application on the face, topical corticosteroids may create perioral dermatitis or aggravate rosacea (see sections 4.3 and 4.4).

Folliculitis phenomena have been reported.

Delayed healing of atonic wounds, pressure sores, leg ulcers may be observed (see section 4.3).

General disorders and administration conditions

Unknown frequency: Irritation at the application site

Eye disorders

Unknown frequency: blurred vision (see section 4.4).

Reporting of suspected adverse effects

Reporting suspected adverse effects after authorisation of the medicinal product is important. It allows continuous 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 .