Anauran 25 ml ear drops solution

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Acute and chronic ear infections.

ACTIVE INGREDIENTS

100 ml of solution contains: Active ingredients Polymyxin B sulphate I.U. 1,000,000; Neomycin sulphate 0.500 g (equal to neomycin base 0.375 g); Lidocaine hydrochloride 4 g. Excipients with known effects: benzalkonium chloride and propylene glycol. For the full list of excipients, see section 6.1.

EXCIPIENTS

Benzalkonium chloride, Propylene glycol, Glycerol, Purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

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.

DOSAGE

- Adults 4-5 drops, 2-4 times a day. - Children 2-3 drops, 3-4 times a day. Instill, using the appropriate dropper, into the ear canal while keeping the head tilted to the side for a few minutes. The treatment period varies in relation to the speed of the therapeutic response, it is recommended not to use the medicine for more than 10 consecutive days.

CONSERVATION

No particular precautions.

WARNINGS

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.

Skin and subcutaneous tissue disorders - Adverse reactions: Allergic dermatitis, itching.

Systemic disorders and conditions relating to the administration site - Adverse reactions: Irritation at the application site.

Injury, poisoning and procedural complications - Adverse reactions: 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.

OVERDOSE

No cases of overdose have been reported.

PREGNANCY AND BREASTFEEDING

Pregnancy: There are no adequate and well-controlled studies in pregnant women. The medicine must be used during pregnancy only in cases of actual necessity and under direct medical supervision. Breastfeeding: Caution should be used when the medicine is used by breastfeeding women.

EFFECTS ON DRIVING ABILITY

Anauran does not affect the ability to drive and use machines.