
In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219
INDICATIONS
Polaramin 1% cream It is indicated for the local symptomatic treatment of itchy dermatitis, sunburn and insect bites.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1.
WARNINGS AND PRECAUTIONS FOR USE
Polaramin 1% cream It is not for ophthalmic use. Polaramin 1% cream it is well tolerated but its use, especially if prolonged, can give rise to sensitization phenomena, as with all topical products. In this case, suspend treatment and institute suitable therapy. Avoid application on very large areas in the presence of abrasions to avoid systemic absorption. If absorbed, it may cause excitability, especially in children. Do not apply on exuding surfaces, on live sores, on areas of skin with blisters, genital organs, mucous membranes. Exposure to the sun of the treated areas can give rise to photosensitization phenomena. Stop using Polaramin 1% cream if you experience a burning sensation or rash, or if the original condition persists or if irritation develops. Avoid occlusive dressing. The use of antihistamines should be stopped approximately 48 hours before carrying out skin tests as these medicines can prevent or reduce positive reactions. The medicine contains: - cetyl alcohol and ethoxylated esters of lanolin which can cause local skin reactions (e.g. contact dermatitis); - methyl parahydroxybenzoate which can cause allergic reactions (even delayed); - an aroma containing limonene and linalool. Limonene and linalool can cause allergic reactions.
INTERACTIONS
Not known.
SIDE EFFECTS
The local application of Polaramin 1% cream it can cause burning, skin rashes and photosensitivity reactions. After topical application of antihistamines on large areas of the skin, systemic side effects have been reported. Reporting of suspected adverse reactions Reporting of suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous 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, https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse








