DERMOCORTAL * CREAM 20G 0.5%

DERMOCORTAL * CREAM 20G 0.5%

Therapeutic indications

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

Dosage and method of use

Dosage: Spread the cream on the affected area in a thin layer 2-3 times a day, rubbing lightly. The maximum recommended treatment duration is 3 days for erythema, 7 days for other indications. If there is no response to therapy, clinical evaluation is required.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. The use of hydrocortisone is contraindicated in the course of viral, bacterial and fungal diseases.

Side effects

Eye disorders: blurred vision with frequency not known (see also section 4.4). Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

The cream is not used ophthalmologically, nor should it be applied in the periocular areas. Not to be used in vulvar itching, if associated with vaginal discharge. The use, especially if prolonged, of products for topical use can give rise to phenomena of irritation or sensitization. In this case it is necessary to interrupt the treatment and carry out a clinical evaluation for the management of the clinical picture. Respect the recommended treatment duration (see section 4.2) avoiding prolonged applications, especially on large surfaces.Pediatric population: In children under 2 years of age, the product should be administered in cases of real need and under direct medical supervision.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, 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 use of systemic and topical corticosteroids.Important information about some of the ingredients: Dermocortal contains methyl parahydroxybenzoate and propyl parahydroxybenzoate: they can cause allergic reactions (even delayed). Dermocortal contains benzyl alcohol: it can cause slight local irritation. Dermocortal contains scented essence, in turn containing amyl cinnamal, amyl cinnamyl alcohol, anisyl alcohol, benzyl alcohol, benzyl benzoate, benzyl cinnamate, benzyl salicylate, cinnammal, cinnamyl alcohol, citral, citronellol, coumarin, eugenol, farnesol, geraniol, aldehyde exylnamic , hydroxytronellal, hydroxy methyl pentyl cyclohexene carboxaldehyde, isoeugenol, limonene, linalool. Amyl cinnamal, amyl cinnamyl alcohol, anisyl alcohol, benzyl alcohol, benzyl benzoate, benzyl cinnamate, benzyl salicylate, cinnammal, cinnamyl alcohol, citral, citronellol, coumarin, eugenol, farnesol, geraniol, exyl cinnamic aldehyde, hydroxycitronellal, cyclohexide methyl methylated isoeugenol, limonene, linalool can cause allergic reactions.

Pregnancy and breastfeeding

In pregnant women, the product should be administered in case of real need, under the direct supervision of the doctor.

Expiration and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

There are no known drug interactions with other drugs.

Overdose

There are no overdose problems except as indicated in section 4.4.

Active principles

1 g of cream contains: 5 mg hydrocortisone.Excipients with known effects:methyl parahydroxybenzoate and propyl parahydroxybenzoate, scented essence. For the full list of excipients, see section 6.1.

Excipients

Palmite stearate of glycerol and polyethylene glycol associated with polyoxyethylenate cetylstearyl alcohol, polyglycolysed isostearic glycerides, glycerol monostearate, phenoxyethanol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, isostearyl isostearate, liquid paraffin, purified water.