Fenistil 0.1% 30 g gel

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

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

ACTIVE INGREDIENTS

One gram of gel contains dimethindene maleate 1 mg Excipients with known effects: propylene glycol, benzalkonium chloride. For the full list of excipients, see section 6.1.

EXCIPIENTS

Benzalkonium chloride; sodium edetate; carbomer; sodium hydroxide; propylene glycol; purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

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

DOSAGE

Apply the gel on the affected part with a light massage, to favor its deep penetration, 2-3 times a day, depending on the intensity of the inflammatory symptom. Do not exceed the recommended doses. Use only for short periods of time (no longer than 5-7 days).

CONSERVATION

Store below 25°C.

WARNINGS

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.

OVERDOSE

Symptoms So far, no case of overdose with Fenistil gel has been reported. However, accidental ingestion of considerable quantities of Fenistil gel may induce some symptoms characteristic of overdose with type H antihistamines₁: CNS depression with drowsiness (especially in adults), CNS stimulation and anticholinergic effects (especially in children and the elderly), including excitement, ataxia, hallucinations, tonic-clonic spasms, mydriasis, dry mouth, facial flushing, urinary retention and fever. Hypotension may also occur. Management There is no specific antidote in case of overdose of antihistamines. The usual emergency measures must be implemented which include, in case of ingestion: activated charcoal, saline laxatives and, if necessary, the usual cardiorespiratory support measures. No stimulants should be administered; vasopressor drugs may be used to treat hypotension.

PREGNANCY AND BREASTFEEDING

Pregnancy No clinical data on pregnancy are available for dimethindene maleate. Animal studies have not shown any direct or indirect harmful effects on pregnancy or the fetus/newborn. Fenistil gel should be used during pregnancy only after the doctor has assessed the risk/benefit ratio in favor of the latter. During pregnancy, Fenistil gel should not be applied to large skin surfaces, especially if abraded or inflamed. Breastfeeding Fenistil gel should be used during breastfeeding only after the doctor has assessed the risk/benefit ratio in favor of the latter. During breastfeeding, Fenistil gel should not be applied to large skin surfaces, especially if abraded or inflamed. However, the product should not be applied to the breasts during breastfeeding.

EFFECTS ON DRIVING ABILITY

Fenistil gel has no or negligible influence on the ability to drive and use machinery.