Fenistil 0,1% 30g gel

Fenistil 0.1% 30g gel is a topical antihistamine gel , formulated for the local symptomatic treatment of itchy dermatitis , sunburn and insect bites . Thanks to its active ingredient, dimethindene maleate , Fenistil gel acts quickly to relieve itching , burning and skin irritation caused by skin allergies or external agents. Its light and transparent formulation is easily absorbed, offering immediate relief without greasing the skin.

Fenistil 0.1% gel is particularly suitable for those looking for an effective over-the-counter medicine against allergy itching , sting itching and erythema itching . The product is suitable for both adults and children, and can be applied directly to the affected area for a targeted and rapid action. The presence of excipients such as propylene glycol and benzalkonium chloride helps keep the skin hydrated and protected, while the gel texture guarantees an immediate sensation of freshness.

Fenistil 30g gel is the ideal solution for those who want a practical and fast local treatment against skin irritations of various origins. Thanks to its effectiveness and ease of use, it represents an indispensable ally to always keep on hand at home or when traveling, to intervene promptly in case of skin allergies , insect bites or sunburn .

ACTIVE INGREDIENTS

Active ingredients contained in Fenistil 0.1% 30 g gel - What is the active ingredient of Fenistil 0.1% 30 g gel?

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

EXCIPIENTS

Composition of Fenistil 0.1% 30g gel - What does Fenistil 0.1% 30g gel contain?

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

DIRECTIONS

Therapeutic indications Fenistil 0.1% 30 g gel - Why is Fenistil 0.1% 30 g gel used? What is it used for?

Local symptomatic treatment of pruritic dermatitis, sunburn, insect bites.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Fenistil 0.1% 30 g gel - When should Fenistil 0.1% 30 g gel not be used?

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Do not use under occlusive dressing.

DOSAGE

Quantity and method of taking Fenistil 0.1% 30 g gel - How to take Fenistil 0.1% 30 g gel?

Apply the gel to the affected area with a light massage, to promote 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 (not more than 5-7 days).

CONSERVATION

Storage Fenistil 0.1% 30 g gel - How is Fenistil 0.1% 30 g gel stored?

Store below 25°C.

WARNINGS

Warnings Fenistil 0.1% 30 g gel - It is important to know that Fenistil 0.1% 30 g gel:

The use, especially if prolonged, of products for topical use may 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; do not apply it to areas of skin with vesicles, on open wounds, on exuding surfaces. Avoid contact of the preparation with the eyes and prolonged exposure of the treated areas to the sun. Paediatric population In children under 2 years of age, the use of the preparation on large skin surfaces should be avoided, particularly on excoriated and inflamed areas. 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 benzalkonium chloride per dose (2 g gel) equivalent to 0.05 mg/g gel which may irritate the skin. If you are breast-feeding, do not apply this medicine to your breasts because the baby may swallow it with her milk.

INTERACTIONS

Interactions Fenistil 0.1 % 30 g gel - Which medicines or foods can modify the effect of Fenistil 0.1 % 30 g gel?

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

SIDE EFFECTS

Like all medicines, Fenistil 0.1% 30 g gel can cause side effects - What are the side effects of Fenistil 0.1% 30 g gel?

Summary of safety profile The most commonly reported adverse reactions during treatment are mild and transient skin reactions at the application site. Tabulated list of adverse reactions Adverse reactions are listed below by system organ class and frequency. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. The 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 (cannot be estimated from the available data). Skin and subcutaneous tissue disorders: Uncommon: dry skin, burning sensation of 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 authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. 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

Overdose Fenistil 0.1% 30 g gel - What are the risks of Fenistil 0.1% 30 g gel in case of overdose?

Symptoms No case of overdose with Fenistil gel has been reported to date. However, accidental ingestion of considerable quantities of Fenistil gel may induce some symptoms characteristic of overdose with H ₁ -type antihistamines: CNS depression with drowsiness (especially in adults), CNS stimulation and anticholinergic effects (especially in children and the elderly), including excitement, ataxia, hallucinations, tonic-clonic jerks, mydriasis, dry mouth, facial flushing, urinary retention and fever. Hypotension may also occur. Management There is no specific antidote for antihistamine overdose. The usual emergency measures should be implemented, including in case of ingestion: activated charcoal, saline laxatives and, if necessary, the usual cardiorespiratory support measures. Stimulants should not be administered; vasopressor drugs may be used to treat hypotension.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Fenistil 0.1% 30 g gel.

Pregnancy For dimetindene maleate no clinical data are available in pregnant women. Animal studies have not shown direct or indirect harmful effects on pregnancy or on 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 areas of skin, especially if excoriated 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 areas of skin, especially if excoriated or inflamed. The product should not be applied to the breast during breastfeeding.

DRIVING AND USE OF MACHINERY

Taking Fenistil 0.1% 30 g gel before driving or using machines - Does Fenistil 0.1% 30 g gel affect driving or using machines?

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