FENISTIL 0.1% GEL 30G

FENISTIL 0.1% GEL

active ingredients

A gram of gel contains malato dimetindene 1 mg Eccipients with known effects: glycol propylene, benzalconio chloride. For the full list of excipients, see paragraph 6.1.

Excellent

Benzalconio chloride; sodium edetate; carbomer; sodium hydroxide; propylenglycol; purified water.

Therapeutic indications

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

Contraindications

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

Population

Apply the gel on the affected part with mild massage, to favor its penetration in depth, 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 (not over 5-7 days).

Conservation

Store at a temperature below 25°C.

Warnings

The use, especially if prolonged, of products for topical use can give rise to phenomena of sensitization; if this occurs, the treatment must be suspended and appropriate therapy is established. Avoid the application of the product when the skin has very extensive abrasions, to avoid a systemic absorption of the product; do not apply it also on areas of skin with vesicles, on living sores, on exudatory 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 the use of the preparation on extensive skin surfaces should be avoided, especially on escoriate and inflamed areas. Information on excipients: Fenistil gel contains 300 mg of glycol propylene per dose (2 g gel) equivalent to 150 mg/g of gel that can cause skin irritation. Fenistil gel also contains 0.1 mg of benzalconium chloride per dose (2 g gel) equivalent to 0.05 mg/g of gel that can irritate the skin. If you are breastfeeding do not apply this medicine on the breast because the child could ingest it with his milk.

Interactions

Interaction studies have not been carried out; however the absorption in the body of the active ingredient contained in Fenistil 0.1% gel, is very low and therefore the interactions are very unlikely.

Effects

Summary of security profile: The most commonly reported adverse reactions during treatment are mild and transient skin reactions to the application site. Table of adverse reactions Adverse reactions are listed below, by classification for systems, organs and frequency. Within each frequency class, unwanted effects are reported in decreasing order of gravity. Frequency categories for each adverse reaction include: very common (≥1/10); common (≥1/100, Pathologies of skin and subcutaneous tissue. Not common: dryness of the skin, burning sensation to the skin; Very rare (based on post-marketing reports): allergic dermatitis; Frequency not known: allergic skin reactions. 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: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Synonyms So far no case of overdose has been reported with Fenistil gel. However, accidental ingestion of considerable amounts of Fenistil gel can induce some characteristic overdose symptoms with antihistamines of the type H₁: SNC depression with drowsiness (especially in adults), SNC stimulation and anti-cholinergical effects (especially in children and elderly), including excitement, ataxia, hallucinations, tonic-clonic spasms, midriasis, mouth dryness, face heat flashes, urinary retention and fever. Hypotension may also appear. Management There is no specific antidote in case of overdose of antihistamines. The usual emergency measures must be implemented which include in the event of ingestion: activated carbon, laxative salins and, if necessary, the usual cardiorespiratory support measures. No stimulants should be given; vasopressor drugs can be used to treat hypotension.

Pregnancy: Clinical data in pregnancy are not available for male dimetindene. Animal studies have not shown direct or indirect harmful effects on pregnancy or on fetus/neonate. Fenistil gel should be used during pregnancy only after the doctor assessed the risk/benefit ratio for the latter. During pregnancy, Fenistil gel should not be applied on extensive skin surfaces, especially if escoriate or inflamed. Food: Fenistil gel should be used during breastfeeding only after the doctor assessed the risk/benefit ratio for the latter. During breastfeeding, Fenistil gel should not be applied on extensive skin surfaces, especially if escoriate or inflamed. The product should not be applied on the breast during breastfeeding.

Source: Farmadati