BETAMETHASONE BIOGARAN 0,05 % Cr T/30g

Micronised betamethasone dipropionate............................................................................................0,064 g

Corresponding quantity of betamethasone.........................................................................................0,050 g

For 100 g of cream.

Excipients with known effect: cetostearyl alcohol and chlorocresol.

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

• contact eczema;

• atopic dermatitis;

• lichenification.

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

• stasis dermatitis;

• psoriasis (excluding very extensive plaques);

• lichen;

• non-parasitic prurigo;

• dyshidrosis;

• genital lichen sclerosus et atrophicus;

• granuloma annulare;

• discoid lupus erythematosus;

• seborrhoeic dermatitis with the exception of the face ;

• symptomatic treatment of pruritus in mycosis fungoides.

3. Indications of circumstance for a short duration :

• insect bites and parasitic prurigo after aetiological treatment.

The cream form is particularly intended for acute, weeping 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.

BETAMETHASONE BIOGARAN is intended for cutaneous use only.

Dosage

Treatment should be limited to 1 to 2 applications per day.

An increase in the number of daily applications would risk worsening adverse effects without improving therapeutic effects.

Treatment of large areas requires monitoring of the number of tubes used.

Method of administration

It is advised to apply the product in spaced dabs, then spread it by massaging lightly until it is completely absorbed.

Certain dermatoses (psoriasis, atopic dermatitis...) make a gradual discontinuation desirable. It may be achieved by reducing the frequency of applications and/or by using a less potent or less concentrated corticosteroid.

• Hypersensitivity to the active substance or to any of the excipients listed in section Composition ;

• primary bacterial, viral, fungal or parasitic infections;

• ulcerated lesions;

• acne;

• rosacea;

• application to the eyelids (risk of glaucoma).

Prolonged use on the face of high-activity corticosteroids exposes to the occurrence of corticosteroid-induced and paradoxically corticosteroid-sensitive dermatitis, with rebound after each discontinuation. A gradual withdrawal, particularly difficult, is then necessary.

Due to the passage of the corticosteroid into the general circulation, treatment over large areas or under occlusion may lead to the systemic effects of general corticotherapy, particularly in infants and young children. They consist of a Cushingoid syndrome and slowing of growth. These effects disappear on discontinuation of treatment, but an abrupt discontinuation may be followed by acute adrenal insufficiency.

BETAMETHASONE BIOGARAN is not intended for ophthalmic use.

In infants, it is preferable to avoid high-activity corticosteroids. Particular caution should be exercised regarding spontaneous occlusion phenomena that may occur in skin folds or under diapers.

In case of bacterial or mycotic infection of a corticosteroid-sensitive dermatosis, precede the use of the corticosteroid with specific treatment.

If local intolerance appears, treatment must be discontinued and the cause must be investigated.

Visual disturbances may occur during systemic or local corticotherapy (notably via nasal, inhaled and intraocular routes). In case of blurred vision or onset of any other visual symptom during corticotherapy, an ophthalmological examination is required to look for visual disorders, notably cataract, glaucoma, or a rarer lesion such as central serous chorioretinopathy, described with the administration of corticosteroids by systemic or local route.

This medicine contains cetostearyl alcohol and may cause local skin reactions (for example: contact eczema).

This medicine contains chlorocresol and may cause allergic reactions.

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 study has been performed with topical corticosteroids.

Nevertheless, studies concerning the intake of corticosteroids per os have not demonstrated a malformative risk greater than that observed in the general population.

Breast-feeding

During treatment per os, breastfeeding should be avoided because corticosteroids are excreted in breast milk.

Topically, the transdermal passage and therefore the risk of corticosteroid excretion into breast milk will depend on the treated surface area, the degree of epidermal damage and the duration of treatment.

Prolonged use of potent corticosteroids may lead to skin atrophy, telangiectasias (to be particularly feared on the face), striae (especially 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 cause perioral dermatitis or worsen rosacea, see sections Warnings and precautions and Contraindications).

A delay in healing of atonic wounds, bedsores, and leg ulcers may be observed (see section Contraindications).

Possibility of systemic effects (see section Warnings and precautions).

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

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

Blurred vision (see also section Warnings and precautions) has been reported with the use of corticosteroids (frequency not known).

Reporting of suspected adverse reactions

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

Symptoms: excessive or prolonged use of topical corticosteroids may lead to inhibition of the hypothalamic-pituitary axis resulting in secondary adrenal insufficiency and may cause manifestations of hypercorticism, including Cushing's disease.

Treatment: appropriate symptomatic treatment is indicated. Symptoms of acute hypercorticism are generally reversible. Correct electrolyte disturbances if necessary. In cases of chronic toxicity, gradual discontinuation of corticosteroids is advised.

Pharmacotherapeutic class: Dermocorticoid, ATC code: D07AC01.

Dermocorticoids are classified into 4 levels of activity according to skin vasoconstriction tests: very potent, potent, moderate, weak.

Betamethasone 0,05 percent cream is of potent activity.

Active on certain inflammatory processes (for example: contact hypersensitivity) and the associated pruritic effect. Vasoconstrictor. Inhibits cell proliferation.

The extent of transdermal passage and systemic effects depends on the size of the treated surface area, the degree of epidermal damage and the duration of treatment. These effects are all the more to be feared the longer the treatment is prolonged.

3 years.

After first opening: store for a maximum of 3 years, without exceeding the expiry date.

To be stored at a temperature not exceeding 30°C.

No special requirements.

• Indication(s) appearing in the marketing authorisation at the date of publication of this decree