Lenirit 0.5% dermatological cream

SOOTHING 0.5% CREAM

Therapeutic indications

Insect bites, itching, localized erythema or burns, eczema.

Dosage and method of use

Rubbing lightly, spread the cream on the affected part in a thin layer, twice a day. Do not exceed the recommended dose. LENIRIT must not be used in children under two years of age (see section 4.3).

Contraindications

Known hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. Skin infections and diseases: tuberculosis, pyoderma, mycosis, as well as skin ulcers and wounds, skin tumors. The use of the cream is contraindicated on the skin of the face, anogenital area, large lesions, infectious diseases (syphilis), viral infectious diseases (such as herpes, chickenpox), perioral dermatitis, acne, acne rosacea, skin reactions after a vaccination, pustular psoriasis. Lenirit should not be used in infants and children under 2 years of age.

Side effects

The use, especially if prolonged, of products for topical use can give rise to irritation or sensitization phenomena. In this case it is necessary to interrupt treatment and institute appropriate therapy. Acne, steroid-induced purpura, dry skin, hypertrichosis, hypopigmentation of the skin, skin atrophy and striae, telangiectasia, perioral dermatitis, folliculitis, pruritus, blurred vision may occur during application of the cream (see also section 4.4). The greater absorption due to the use of an occlusive bandage can cause systemic effects such as edema, hypertension and compromise of the immune system; hypothalamic-pituitary-adrenal axis suppression and Cushing's syndrome may also occur, particularly in pediatric patients. Prolonged use of corticosteroids in children may cause growth and development disorders (see section 4.4). Glaucoma or cataracts may occasionally occur following topical application in the eyelid area (see section 4.4).The incidence of adverse reactions is unknown. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous 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 at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

If conditions worsen or if symptoms persist for more than 7 days, discontinue applications and consult a doctor. Avoid contact with eyes. The use, especially if prolonged, of topical medicines can give rise to irritation or sensitization phenomena. In this case it is necessary to interrupt treatment and institute appropriate therapy. Prolonged use of this medicine may cause telangiectasia and skin atrophy. When used over a long period, or on a large area of skin, hydrocortisone can be absorbed into the blood and exert systemic activity. This eventuality occurs more easily if occlusive dressing is used; the diaper can act as an occlusive bandage. Systemic absorption of topical corticosteroids may result in reversible suppression of the hypothalamic-pituitary-adrenal axis with potential glucocorticosteroid failure following discontinuation of treatment. Following systemic absorption of topical corticosteroids, some patients may also experience manifestations of Cushing's syndrome, glycosuria, hyperglycemia during treatment. Patients who apply a topical steroid to a large surface area or to occlusive areas should be monitored periodically for hypothalamic-pituitary-adrenal axis suppression. Visual disturbances: Visual disturbances may be reported with the use of systemic and topical corticosteroids. If a patient presents with symptoms such as blurred vision or other visual disturbances, a referral to an ophthalmologist should be considered for evaluation of possible causes which may include cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy (CSCR), which have been reported after the use of systemic and topical corticosteroids. In case of use in the area adjacent to the eyes, appropriate precautions should be taken. If this happens, the cream residue must be rinsed off with water. The cream contains ethyl parahydroxybenzoate, methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (even delayed).Pediatric population: Do not use in infants and children under 2 years of age (see section 4.3). Particular caution is recommended when using the medicine in children due to the risk of systemic exposure to hydrocortisone. Because the body surface area to body weight ratio in children is higher than that in adults, children are at greater risk for systemic corticosteroid effects, including hypothalamic-pituitary-adrenal axis suppression and Cushing's syndrome, than adults. Prolonged use of corticosteroids in children may cause growth and development disorders. The duration of treatment should be as short as possible and the lowest dose should be used. The growth and development of the child should be monitored (see section 4.4).Use in elderly patients: Elderly people may experience more marked side effects, especially in cases of co-morbidities, such as osteoporosis, hypertension, hypokalemia, diabetes mellitus, in addition to greater susceptibility to infections and reduction in skin thickness. These people must be carefully monitored to avoid the appearance of life-threatening reactions. In case of subcutaneous atrophic conditions, especially in the elderly, the medicine should be used with caution.Use in patients with renal or hepatic impairment: Particular precautions for use must be used in patients with liver disease or renal failure and frequent clinical monitoring of the state of health is necessary.

Pregnancy and breastfeeding

The use of Lenirit is not recommended during pregnancy and breastfeeding.

Expiration and conservation

This medicine does not require any special storage conditions.

Interactions with other drugs

No cases of interaction and incompatibility with other medicinal products have been reported.

Overdose

Cases of overdose are not known with the topical use of hydrocortisone at the concentration contained in LENIRIT (0.5%), however prolonged applications should be avoided, particularly on large surfaces. If high doses of the medicinal product are used on large areas of skin, under tight-fitting clothing or on damaged skin, the medicinal product may be absorbed into the blood and cause systemic corticosteroid effects (see section 4.4). In this case, a gradual discontinuation of treatment is recommended.

Active principles

100 g of cream contains:Active principle: hydrocortisone acetate 0.5 g.Excipients with known effects: methyl parahydroxybenzoate; ethyl parahydroxybenzoate; propyl parahydroxybenzoate. For the full list of excipients, see section 6.1.

Excipients

Polyglycolic ester of C12-C18 fatty acids; self-emulsifying glyceryl monodistearate; squalane; cetyl palmitate; methyl parahydroxybenzoate; ethyl parahydroxybenzoate; propyl parahydroxybenzoate; perfume; purified water.