Anauran 25 ml ear drops solution

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Acute and chronic ear infections.

CONTRAINDICATIONS

ANAURAN is contraindicated: - in patients who have hypersensitivity to Polymyxin B sulphate, Neomycin sulphate and Lidocaine hydrochloride and to compounds closely related from a chemical point of view or to any of the excipients; - in patients with perforated tympanic membrane, due to the risk of ototoxicity.

WARNINGS AND PRECAUTIONS FOR USE

The use of topical products, especially if prolonged, can give rise to sensitization phenomena. In this case, stop treatment and consult your doctor to institute suitable therapy. In the presence of deep or resistant infections it is advisable to integrate the local medication with appropriate general antibiotic treatments. As with other antibiotic preparations, prolonged treatments can give rise to superinfections with resistant germs. Neomycin can induce permanent sensorineural hearing loss following damage to the cochlea, especially with the destruction of the hair cells of the organ of Corti. The risk of ototoxicity is greater in case of prolonged use, therefore a duration of therapy limited to 10 consecutive days is recommended. Cross allergy and cross resistance may occur with other aminoglycoside derivatives. ANAURAN must be used exclusively in otological settings; applications elsewhere are inappropriate. Important information about some excipients: The medicine contains 0.001 mg benzalkonium chloride in each drop, which may irritate the skin. The medicine contains 11.6 mg of propylene glycol in each drop which may cause skin irritation.

INTERACTIONS

There are no known interaction studies with the active ingredients present in the medicinal specialty.

SIDE EFFECTS

The following adverse reactions have been reported following administration of Anauran. The frequency cannot be estimated from the available data.

Classification by systems and organs | Adverse reactions

Skin and subcutaneous tissue disorders | Allergic dermatitis, itching

Systemic disorders and conditions relating to the administration site | Irritation at the application site

Injury, poisoning and procedural complications | Ototoxicity (see section 4.4)

Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.