CORTISEDERMYL 0,5 % Cream Tube/15g

Hydrocortisone.............................................................................................................................................. 0.50 g

Excipient(s) with known effect: wool fat, cetyl alcohol, stearyl alcohol.

This medicine is indicated in adults and children over 6 years of age for:

• nettle stings,
• insect bites,
• localised sunburn.

Dosage

KEEP OUT OF REACH OF ADULTS AND CHILDREN OVER 6 YEARS.

• 2 applications per day.

An increase in the number of applications increases the risk of adverse effects without improving therapeutic effects.

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

Wash hands after application.

The duration of treatment is limited to three days.

• Hypersensitivity to any of the constituents of the cream,
• Ulcerated skin lesions, wounds,
• Acne,
• Rosacea,
• Bacterial, viral, fungal and parasitic skin infections.

Precautions for use

• Do not treat large areas, do not use an occlusive dressing.
• Do not apply other dermatological products to the treated surface.
• Do not increase the frequency of applications.
• If the itching persists, or in case of local intolerance or cutaneous superinfection, treatment must be stopped and the course of action reassessed.

Pregnancy

No animal teratogenicity study has been carried out with corticosteroids administered topically.

Nevertheless, studies concerning oral corticosteroid use in pregnant women have not shown a malformation risk greater than that observed in the general population.

Consequently, this medicine may be prescribed during pregnancy if needed.

Breast-feeding

Breast-feeding is possible during treatment with this medicine.

Do not apply to the breasts during breastfeeding because of the risk of the newborn ingesting the product.

Reporting of suspected adverse reactions

As this medicine contains a corticosteroid of weak activity and low dosage, the undesirable effects described below are minimised.

Prolonged use of corticosteroids of strong or very strong activity may lead to cutaneous atrophy, telangiectasias (to be feared particularly on the face), striae (particularly at the root of the limbs, and occurring more readily in adolescents), ecchymotic purpura secondary to atrophy, and skin fragility.

These effects are rare with low-potency corticosteroids such as hydrocortisone at 0,5 %.

On the face, corticosteroids may cause perioral dermatitis or worsen rosacea.

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

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.

Due to the presence of wool fat, risk of contact eczema.

May cause local skin reactions (for example contact dermatitis).

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:www.signalement-sante.gouv.fr.

The risk of overdose does not exist under normal conditions of use.

Pharmacotherapeutic class: LOW-POTENCY CORTICOSTEROIDS (GROUP I), ATC code: D07AA02.

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

CORTISEDERMYL 0,5%, cream is low-potency.

Active on certain inflammatory processes such as contact hypersensitivity and the associated pruritic effect; vasoconstrictor, inhibits cell multiplication.

The extent of transdermal absorption and of systemic effects depends on the treated surface area, the degree of epidermal alteration, and the duration of treatment. These effects are all the more significant the longer the treatment is prolonged.

3 years.

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

No special requirements.