Fenistil 0.1% Dimethindene maleate Itching Gel 30 gr

WARNINGS
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena; if this occurs, treatment must 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 also on areas of skin with blisters, on living sores, on exuding surfaces. Avoid contact of the preparation with the eyes and prolonged exposure to the sun of the treated areas. In children under 2 years of age, do not use the preparation without medical advice. In infants and infants, in particular, the use of the preparation on large skin surfaces, particularly on excoriated and inflamed areas, must be avoided. The medicine contains propylene glycol which can cause skin irritation. It also contains benzalkonium chloride which is irritating and can cause skin reactions.
PHARMACOTHERAPEUTIC CATEGORY
Antipruritics, including antihistamines, anesthetics, etc.
STORAGE
Store below 25 degrees C.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the listed excipients; do not use with occlusive dressing; generally contraindicated in pregnancy and lactation.
NAME
FENISTIL 0.1% GEL
EXCIPIENTS
Benzalkonium chloride; sodium edetate; carbopol 974 P; sodium hydroxide; propylene glycol; purified water.
SIDE EFFECTS
The most commonly reported adverse reactions during treatment are mild and transient skin reactions at the application site. Adverse reactions are listed below, by system organ class and frequency. Within each frequency class, undesirable effects are reported in descending order of severity. 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). Skin and subcutaneous tissue disorders. Uncommon: dry skin, skin burning sensation; very rare (based on post-marketing reports): allergic dermatitis. Skin allergic reactions (frequency not known). The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.
PREGNANCY AND BREASTFEEDING
In pregnant women, the product should be used only in cases of actual need. During pregnancy, the drug should not be applied to extensive skin surfaces, especially if excoriated or inflamed. During lactation, the product should be used only in case of actual need. During breastfeeding, the gel medicinal product should not be applied to large skin surfaces, especially if excoriated or inflamed. However, the product should not be applied to the nipples during breastfeeding.
INDICATIONS
Local symptomatic treatment of itchy dermatitis, sunburn, insect bites.
INTERACTIONS
No interaction studies have been performed; however, the absorption in the body of the active ingredient contained in the product is very low and therefore interactions are very unlikely.
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 dose. Use for short periods of time only (no longer than 5-7 days).
ACTIVE PRINCIPLES
Dimethindene maleate.