Cortidro 0.5% cream 20g

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

The product is used in case of insect bites, itching, erythema or localized burns, eczema.

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS FOR USE

The cream is not used in ophthalmology nor should it be applied to the areas around the eyes. Avoid use in the treatment of vulvar itching if associated with vaginal discharge. Avoid prolonged applications, particularly on large surfaces. The use, especially if prolonged, of topical products can give rise to irritation or sensitization phenomena. In this case it is necessary to interrupt treatment and consult your doctor in order to institute suitable therapy. 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 the use of systemic and topical corticosteroids. Pediatric population In children under two years of age, the product should be administered in cases of actual need under the direct supervision of a doctor.

INTERACTIONS

It is necessary to observe caution in the association of corticosteroids with amphotericin B because they can combine their hypokalemic actions. Corticosteroids antagonize the effects of anticoagulants, therefore simultaneous use with them is not recommended, especially if they are coumarin derivatives. Barbiturates accelerate the metabolism of corticosteroids due to enzymatic induction and reduce their effect, therefore their combination is not recommended.

SIDE EFFECTS

Systemic side effects of corticosteroid preparations for topical use are extremely unlikely due to the low doses used: if they occur, discontinue therapy. Eye disorders, uncommon (≥1/1,000, <1/100): Vision, blurred (see also section 4.4). Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetti-reazione-avversa