BETNEVAL LOTION 0,1 % Emuls appl cut Fl/15g

Emulsion for cutaneous application.
Dropper bottle of 15 g. 

For 100 g of emulsion for cutaneous application:

Betamethasone: 0,100 g
in the form of betamethasone valerate: 0,122 g

Excipients with known effect: methyl parahydroxybenzoate (E218), cetostearyl alcohol.

Corticosteroid-sensitive dermatoses of the scalp:

• psoriasis,
• seborrhoeic dermatitis.

This emulsion form is particularly suitable for lesions of hairy areas and the scalp.

Note: Each dermatosis must be treated with a corticosteroid of the most appropriate potency level, bearing in mind that, depending on the results, it may be necessary to substitute a product of stronger or weaker activity, over all or part of the lesions.

Apply once or twice daily as a thin layer to the surface to be treated and work in by gentle massage, until the emulsion is fully absorbed.

The lotion must be applied parting by parting, in small quantities, directly onto the scalp. Wash hands after application.

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

In case of worsening or absence of improvement after 2 to 4 weeks, the treatment and diagnosis must be re-evaluated.

When an acute episode has been effectively treated with continuous topical corticosteroid therapy, intermittent treatment may be considered. In cases of chronic intermittent use, the function of the hypothalamic-pituitary-adrenal axis should be evaluated regularly.

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

Due to the flammable nature of betamethasone valerate lotion, patients must avoid smoking or being near a flame during application and immediately after use.

• Hypersensitivity to the active substance or to any of the excipients listed in section Composition,
• Ulcerated lesions
• Untreated infections,
• Acne,
• Rosacea,
• Perioral dermatitis.

Warnings:

Manifestations of hypercorticism (Cushing's syndrome) and reversible inhibition of the hypothalamic-pituitary-adrenal axis, leading to adrenocortical insufficiency, may occur in certain subjects due to increased systemic absorption of topical corticosteroids. In either case, the medicinal product should be discontinued progressively by reducing the frequency of application, or by substituting a corticosteroid of lower activity. Abrupt discontinuation of treatment may lead to adrenal insufficiency (see section Adverse effects).

Factors likely to increase systemic effects are as follows:

• Activity and formulation of the topical corticosteroid,
• Duration of exposure,
• Application over a large area,
• Cutaneous application under occlusion: for example, on intertriginous areas or under an occlusive dressing (in infants, nappies may have the same consequences as an occlusive dressing),
• Increased hydration of the stratum corneum of the skin,
• Application on thin skin surfaces such as the face,
• Application on skin lesions or other situations involving impairment of the skin barrier,
• Compared with adults, children, particularly infants and young children, may absorb proportionally larger amounts of topical corticosteroids and are therefore more exposed to systemic adverse effects (cushingoid syndrome and growth retardation). This is explained by the fact that children have an immature skin barrier and a larger body surface area to weight ratio compared with adults. These effects disappear upon discontinuation of treatment, but abrupt discontinuation may be followed by acute adrenal insufficiency.

Visual disorders

Visual disturbances may occur with systemic or local corticosteroid therapy. In case of blurred vision or the appearance of any other visual symptom during corticosteroid therapy, an ophthalmological examination is required to look for cataract, glaucoma, or rarer lesions such as central serous chorioretinopathy, as described with systemic or local administration of corticosteroids.

Precautions for use

Risk of infection under occlusion

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.

Bacterial infection is promoted by heat and moisture present in skin folds or under an occlusive dressing. When using an occlusive dressing, the skin should be cleaned before each dressing change.

Use in psoriasis

Topical corticosteroids should be used with caution in psoriasis, as rebound effects, development of tolerance, a risk of generalised pustular psoriasis and local or systemic toxicity due to impaired skin barrier have been reported in some cases. Use in the treatment of psoriasis requires careful medical supervision.

Application on the face

Prolonged application to the face is not recommended, as this area is more prone to the risk of skin atrophy. Prolonged use of potent corticosteroids on the face exposes patients to the occurrence of corticosteroid-induced and paradoxically corticosteroid-sensitive dermatitis, with rebound after each discontinuation. A gradual withdrawal, which is particularly difficult, is then necessary.

Application to the eyelids

Prolonged application to the eyelids is not recommended due to the risk of cataract and glaucoma. If applied to this area, care should be taken to ensure that the topical corticosteroid does not enter the eye.

Concomitant infection

An appropriate antimicrobial treatment should be used whenever the treated inflammatory lesions become infected. Spread of the infection requires discontinuation of local corticosteroid therapy and administration of appropriate antimicrobial treatment.

Chronic leg ulcers

Topical corticosteroids are sometimes used to treat dermatitis surrounding chronic leg ulcers. This use may be associated with an increase in local hypersensitivity reactions and the risk of local infection.

Risk of flammability

BETNEVAL LOTION 0,1 %, emulsion for cutaneous application contains paraffin. Inform your patients not to smoke or approach naked flames because of the risk of severe burns. Fabrics (clothing, bedding, dressings, etc.) that have come into contact with this product burn more easily and may pose a fire risk. Washing clothing and bedding may reduce product buildup, but cannot eliminate it completely.

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

Avoid any contact with the eyes and mucous membranes.

Excipients

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

This medicine contains methyl parahydroxybenzoate (E218) and may cause allergic reactions (possibly delayed).

Metabolic disorders such as decreased glucose tolerance are observed with concomitant use of topical corticosteroids and antidiabetic agents. Inform the patient and reinforce blood and urine glucose self-monitoring, especially at the start of treatment.

Pregnancy

Animal studies conducted by the systemic route have shown a teratogenic effect. However, a large number of pregnancies (more than 1 000 pregnancies) exposed systemically to corticosteroids have not revealed any malformative or toxic effect of betamethasone valerate on the fetus or newborn. Therefore, the use of Betneval may be considered during pregnancy if necessary.

Breast-feeding

Corticosteroids pass into breast milk after systemic administration. By the topical route, transdermal passage and therefore the risk of excretion of the corticosteroid into milk will depend on the surface area treated, the degree of epidermal alteration and the duration of treatment.

Therefore, given topical use, 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 to the breasts, the skin should be cleansed before each feed in order to avoid accidental ingestion by the infant.

Fertility

Following prenatal exposure to betamethasone valerate by the intramuscular route, a decrease in sperm quality, plasma testosterone level and fertility was observed in male rats. 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. An adverse effect on these activities cannot be anticipated based on the profile of known adverse effects of topical betamethasone valerate.

Adverse effects are listed below according to the MedDRA system organ classification and by frequency. Frequencies are as follows: very common (≥ 1/10), common (≥ 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) including isolated case reports, and frequency not known (cannot be estimated from available data).

Infections and infestations

Frequency not known: Secondary infections, particularly under occlusive dressings or in skin folds, and allergic contact dermatitis have been reported with the use of topical corticosteroids.

Immune system disorders

Frequency not known: local hypersensitivity.

Endocrine disorders

Frequency not known: Adrenal insufficiency upon abrupt withdrawal of treatment due to suppression of the hypothalamic-pituitary-adrenal axis.

Cushingoid syndrome (which notably manifests as a moon face and central obesity), and whose skin disorders are: skin atrophy, skin thinning, dry skin, striae, telangiectasia.

Skin and subcutaneous tissue disorders

Common: pruritus, local skin burning.

Frequency not known: Changes in pigmentation, hypertrichosis, allergic contact dermatitis/dermatitis, pustular psoriasis, erythema, skin eruptions, urticaria.

Prolonged use of potent topical corticosteroids may lead to ecchymotic purpura secondary to skin atrophy, as well as skin fragility.

Allergic contact dermatitis has also been reported with the use of topical corticosteroids. When applied to the face, topical corticosteroids may cause perioral dermatitis or worsen rosacea (see sections Contraindications and Warnings and precautions).

Folliculitis phenomena have been reported.

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

General disorders and administration site conditions

Frequency not known: irritation at the application site.

Eye disorders

Frequency not known: blurred vision (see section Warnings and precautions).

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.

Signs and symptoms

Absorption of locally applied betamethasone valerate may be sufficient to cause systemic effects. Acute overdose is unlikely; however, in case of chronic overdose or misuse, symptoms of hypercorticism may appear.

Treatment

In case of overdose, betamethasone valerate should be discontinued gradually, by reducing the frequency of application or by substituting a corticosteroid of lower potency, due to the risk of adrenal insufficiency (see section Adverse effects).

Pharmacotherapeutic class: Corticosteroid of strong potency (group III), ATC code: D07AC01.

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

Betamethasone valerate, the active substance of BETNEVAL LOTION 0,1 %, emulsion, is of strong potency.

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

Mechanism of action

Topical corticosteroids have anti-inflammatory properties based on multiple mechanisms; they inhibit the late phase of allergic reactions, notably reduce mast cell density, chemotaxis and eosinophil activation, reduce cytokine production by lymphocytes, monocytes, mast cells and eosinophils, and inhibit arachidonic acid metabolism.

Pharmacodynamic effects

Topical corticosteroids have anti-inflammatory, antipruritic and vasoconstrictive properties.

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.

Absorption

Topical corticosteroids can be absorbed through healthy skin and enter the systemic circulation. The extent of percutaneous absorption of topical corticosteroids depends on various factors, such as the vehicle and the integrity of the epidermal barrier. Occlusive application, inflammation and/or other cutaneous pathological processes may also increase percutaneous absorption.

Certain factors are likely to increase systemic effects (see section Warnings and precautions).

Biotransformation

Once absorbed through the skin, topical corticosteroids follow the same pharmacokinetic pathways as corticosteroids administered systemically. They are metabolised mainly by the liver.

Elimination

Topical corticosteroids are excreted by the kidneys.

No animal study has been carried out to evaluate the carcinogenic potential of betamethasone valerate, the genotoxic potential, or the effect of betamethasone valerate on fertility.

Subcutaneous administration of betamethasone valerate to mice or rats at doses ≥ 0,1 mg/kg/day, and to rabbits at doses ≥ 12 micrograms/kg/day during gestation, resulted in foetal abnormalities, including cleft palate and intrauterine growth retardation.

3 years.

Store at a temperature not exceeding 25 °C.

Keep the container tightly closed when not in use. The contents are flammable. Keep away from all sources of fire, flames or heat. Do not leave the betamethasone valerate lotion bottle in full sun.

No special requirements.