Fenistil 0.1% 30 g gel

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

INDICATIONS

Local symptomatic treatment of itchy dermatitis, solar erythema, insect bites.

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. Do not use with occlusive dressings.

WARNINGS AND PRECAUTIONS FOR USE

The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena; if this occurs, treatment should be suspended and appropriate therapy instituted. Avoid applying the product when the skin has very extensive abrasions, to avoid systemic absorption of the product; also do not apply it on areas of skin with blisters, on live sores or on exuding surfaces. Avoid contact of the preparation with the eyes and prolonged exposure to the sun of the treated areas. Pediatric population In children under 2 years of age, the use of the preparation on large skin surfaces, particularly on abraded and inflamed areas, should be avoided. Information on excipients Fenistil gel contains 300 mg of propylene glycol per dose (2 g of gel) equivalent to 150 mg/g of gel which may cause skin irritation. Fenistil gel also contains 0.1 mg of benzalkonium chloride per dose (2 g of gel) equivalent to 0.05 mg/g of gel which may irritate the skin. If you are breastfeeding, do not apply this medicine to your breasts because your baby may ingest it with his milk.

INTERACTIONS

No interaction studies have been performed; however, the absorption of the active ingredient contained in Fenistil 0.1% gel in the body is very low and therefore interactions are very unlikely.

SIDE EFFECTS

Safety profile summary The most commonly reported adverse reactions during treatment are mild and transient skin reactions at the application site. Table of adverse reactions Adverse reactions are listed below, by system organ class and frequency. Within each frequency class, undesirable effects are presented in order of decreasing seriousness. Frequency categories for each adverse reaction include: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data). Pathologies of the skin and subcutaneous tissue. Uncommon: dry skin, burning sensation on the skin; Very rare (based on post-marketing reports): allergic dermatitis; Frequency not known: allergic skin reactions. 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: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.