HYDRACORT

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

· nettle stings,

· insect bites,

· localized sunburn.

Hypersensitivity to one of the constituents of the cream, notably due to the presence of wool fat (lanolin).

Ulcerated skin lesions, wounds.

Acne.

Rosacea.

Bacterial, viral, fungal and parasitic skin infections.

It is not recommended to treat large areas, namely more than 2 palms of the hand. Do not use occlusive dressings.

Do not apply other products for dermatological use on the treated area. Do not increase the frequency of applications.

In case of persistent pruritus as in case of local intolerance or cutaneous superinfection, the treatment must be stopped and the course of action re-evaluated.

It is recommended to use this product following a consultation with a healthcare professional:

- On thin areas of the skin such as the face which are more likely to present atrophic changes such as skin fragility, delayed healing and/or hypo or hyperpigmentation.

- On damaged skin.

Visual disturbances may be reported during 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 in particular for cataract, glaucoma, or a rarer lesion such as central serous chorioretinopathy, described with the administration of corticosteroids by systemic or local route.

Vigilance is necessary to ensure that the preparation does not enter the eye.

Children are more likely to develop local and systemic adverse effects related to topical corticosteroids, and in general, require shorter treatment durations than adults.

Manifestations of hypercortisolism (Cushing's syndrome) and reversible suppression of the hypothalamic-pituitary-adrenal (HHS) axis, leading to corticosteroid insufficiency, may occur in some individuals due to prolonged duration of use, extensive cutaneous application or increased systemic absorption due to the use of occlusive dressings or application on thin or damaged skin. The first symptoms of HHS axis suppression may include anxiety, mood swings, depression, insomnia, stress, fatigue and fibromyalgia. Cataracts and glaucoma may also develop following prolonged exposure. These manifestations are unlikely to occur if the recommended dosage and administration instructions are followed.

Not applicable.

Pregnancy

There are limited data concerning the use of hydrocortisone in pregnant women. Topical administration of corticosteroids to pregnant female animals has caused fetal development abnormalities (see section 5.3. Preclinical safety data). Consequently, Hydrocortisone 0.5% crème is not recommended during pregnancy.

Breastfeeding

It is unknown whether topical administration of corticosteroids can lead to sufficient systemic absorption to produce detectable amounts in breast milk. A risk to newborns/infants cannot be excluded. Hydrocortisone 0.5 % crème must not be used during breastfeeding, unless necessary. If used during breastfeeding, hydrocortisone cream must not be applied to the breasts to avoid accidental ingestion by the infant.

Fertility

There is no data in humans allowing for the assessment of the effect of topical hydrocortisone on fertility. Limited data suggest that subcutaneous administration of hydrocortisone does not affect fertility in rats (see section 5.3. Preclinical safety data).

Not applicable.

As this medicine contains a low-potency corticosteroid at a low dose, the adverse effects described below are kept to a minimum. Adverse effects are more likely to occur with an increase in dose and duration of use.

Prolonged use of high or very high potency corticosteroids can lead to skin atrophy, telangiectasia (particularly to be feared on the face), stretch marks (notably 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 %. Local hypersensitivity may occur very rarely.

On the face, corticosteroids can create perioral dermatitis or aggravate rosacea.

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

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

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

Due to the presence of wool fat, there is a risk of contact eczema. Perioral dermatitis, erythema, skin rash, urticaria, pruritus, skin pain, dry skin/skin exfoliation, and skin stretch marks may occur very rarely.

Eye disorders with unknown frequency: blurred vision (see section 4.4).

General disorders and administration site conditions - Irritation/pain at the application site, worsening of the condition: very rare.

Reporting of suspected adverse effects

Reporting of suspected adverse effects after authorization of the medicine is important. It allows continuous monitoring of the benefit/risk ratio of the medicine. 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: https://signalement.social-sante.gouv.fr/ .