EXCIPIENTS Palmitostearate of ethylene glycol and polyethylene glycols, polyoxyethylenated glycolysed glycerides, liquid paraffin, butylhydroxyanisole, benzoic acid, purified water.
INDICATIONS Antifungal; infections of the skin and nails caused by dermatophytes or Candida, possibly complicated by bacterial superinfection, such as: tinea pedis, tinea manum, tinea corporis, tinea cruris, tinea unguium, paronychia, angular stomatitis (pearls), otitis externa. The drug also exerts a very rapid action on the itching that frequently accompanies the aforementioned infections.
CONTRAINDICATIONS / SECONDARY EFFECT Hypersensitivity to the active substance, to other imidazole derivatives or to any of the excipients.
DOSAGE Skin infections: apply 1cm of cream or a few drops of emulsion once or twice a day on the lesions, then spread with the finger. The treatment must be continued without interruption until the lesions have completely healed (generally 2 to 5 weeks) Nail infections: cut the infected nails as short as possible, apply a little cream or emulsion 1-2 times a day on the infected nail, spread with your fingers and cover the nail with an occlusive dressing. Continue the treatment without interruption, even after the fall of the infected nail (mostly after 2-3 weeks) until complete regeneration of the nail and the definitive healing of the lesion (usually after 2 months or more). Otitis externa: introduce a little skin emulsion into the ear canal twice a day; healing is generally achieved in 2-3 weeks.
STORAGE This medicine does not require any special storage conditions.
WARNINGS Certain hygiene measures such as the daily washing of the lesions and infected parts, the change and disinfection of socks and shoes, can only favor the therapeutic results of the treatment. The medicine does not stain the skin or clothing. Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with miconazole-based topical formulations. If a reaction due to hypersensitivity or irritation occurs, the treatment should be stopped. The drug must not come into contact with the mucous membrane of the eyes.
INTERACTIONS No interaction studies have been performed.
SIDE EFFECTS Topical therapy with miconazole, in general, is well tolerated: the use of the product, especially if prolonged, can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and institute a suitable therapy. 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 case of pregnancy, the product should be used only in case of real need.
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