LENIRIT CREAM DERM 20G 0.5%

LENIRIT 0.5% CREMA

active ingredients

100 g cream contain: Active ingredient: acetate hydrocortisone 0.5 g. Excipients with known effects: methyl parahydroxybenzoate; parahydroxybenzoate; propile parahydroxybenzoate. For the full list of excipients, see paragraph 6.1.

Excellent

Extend polyglycolic fatty acids C12-C18; self-emulsifying glycerylmonodistearate; squalano; cetile palmitato; methyl parahydroxybenzoate; ethyl parahydroxybenzoate; propile parahydroxybenzoate; perfume; purified water.

Therapeutic indications

Punctures of insects, itchings, erythema or burns, eczema.

Contraindications

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

Population

Frying slightly, spread the cream on the sick part in thin layer, twice a day. Do not exceed the recommended doses. LENIRIT should not be used in children under two years (see paragraph 4.3).

Conservation

This medicine does not require any special condition of conservation.

Warnings

If conditions worsen or if symptoms persist for more than 7 days, stop applications and consult a doctor. Avoid contact with eyes. The use, especially if prolonged, of medicinal products for topical use can give rise to phenomena of irritation or sensitization. In this case it is necessary to stop the treatment and establish suitable therapy. Prolonged use of this medicine can cause teleangiectasia and skin atrophy. When used for a long period, or on a wide area of skin, hydrocortisone can be absorbed in the blood and exercise a systemic activity. Such an eventuality occurs more easily if it is covered with occlusive bandage; the diaper can act as an occlusive bandage. Systemic absorption of the topical corticosteroids can determine reversible suppression of the hypothalamus-hypophysis-surrene axis with a potential glucocorticosteroid failure after suspension of treatment. As a result of the systemic absorption of topical corticosteroids, some patients may also have manifestations of Cushing syndrome, glycosuria, hyperglycemia during treatment. Patients applying a topical steroid on a wide surface or in areas with occlusive bandage should be checked periodically to assess the suppression of hypothalamus-hypophysi-surrene axis. Visual disturbances: With the use of systemic and topical corticosteroids, visual disturbances can be reported. If a patient occurs with symptoms such as blurred vision or other visual disorders, it is necessary to consider referral to an ophthalmologist for the evaluation of possible causes that may include cataracts, glaucoma or rare diseases such as central serum corioretinopathy (CSCR), which were reported after the use of systemic and topic corticosteroids. In case of use in the area adjacent to the eyes take the appropriate precautions. If this happens, the cream residue must be rinsed with water. The cream contains ethyl parahydroxybenzoate, methyl parahydroxybenzoate and propile parahydroxybenzoate that can cause allergic reactions (also delayed). Pediatric population: Do not use in infants and children under 2 years of age (see paragraph 4.3). Special caution is recommended during the use of the medicinal product in children due to the risk of systemic exposure to hydrocortisone. Since the relationship between body surface and body weight in children is higher than in adults, children are more at risk of systemic effects from corticosteroids, including suppression of hypothalamus-hypophysis-surrene and Cushing syndrome, than adults. Prolonged use of corticosteroids in children can cause growth and development disorders. The duration of treatment must be as short as possible and you must use the lowest dose. It is appropriate to monitor the growth and development of the child (see paragraph 4.4). Use in elderly patients: Older people can experience more marked side effects, especially in cases of co-morbidity, such as osteoporosis, hypertension, hypokaliemia, diabetes mellitus, as well as increased susceptibility to infections and reduced skin thickness. These people must be carefully monitored to avoid the emergence of life-threatening reactions. In case of subcutaneous atrophic conditions, especially in the elderly, the medicinal product must be used with caution. Use in patients with kidney or liver failure: In patients with liver disease or kidney failure, special precautions for use must be used and frequent clinical monitoring of the state of health is required.

Interactions

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

Effects

The use, especially if prolonged, of products for topical use can give rise to phenomena of irritation or awareness. In this case it is necessary to stop the treatment and establish suitable therapy. During the application of the cream may manifest acne, purple induced by steroids, dry skin, hypertricosis, skin hypopigmentation, skin atrophy and stries, teleangectasia, perioral dermatitis, follicles, itching, blurred vision (see also paragraph 4.4). The increased absorption due to the use of an occlusive bandage, can cause systemic effects such as edema, hypertension and impairment of the immune system; suppression of hypothalamus-hypophysis-surrene and Cushing syndrome, especially in pediatric patients. Prolonged use of corticosteroids in children can cause growth and development disorders (see paragraph 4.4). Following the topical application in the area of the eyelids, glaucoma or cataract may occasionally occur (see paragraph 4.4). The incidence of adverse reactions is not known. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Overdose cases are not known by the topical use of hydrocortisone to the concentration contained in LENIRIT (0.5%), however avoid prolonged applications, especially on large surfaces. If high doses of medicine are used on large areas of skin, under adhering clothes or on damaged skin, the medicine can be absorbed by the blood and cause systemic effects from corticosteroid (see paragraph 4.4). In this case, a gradual suspension of treatment is recommended.

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

Source: Farmadati