AURIGOUTTE Ear drops Bottle/15ml

Hexamidine diisethionate ..........................................................................................................0,100 g

Lidocaine hydrochloride ........................................................................................................... 0,100 g

For 100 ml.

Antiseptic treatment of external otitis with intact tympanic membrane and their painful manifestations.

Dosage

Adults: 4 drops 3 times a day.

Paediatric population

Infants and children: 2 drops 3 times a day.

Duration of treatment

5 days.

Hypersensitivity to the active substances or to any of the excipients listed in section Composition.

It is imperative to have the state of the tympanic membrane checked before any use because of the risks of ear toxicity in case of tympanic membrane perforation.

No interaction studies have been performed.

Pregnancy

There is no reliable data on teratogenesis in animals. In clinical practice, no particular malformative or foetotoxic effect has appeared to date. However, follow-up of exposed pregnancies is insufficient to exclude any risk.

Consequently, as a precautionary measure, it is preferable not to use this medicine during pregnancy.

The effects on the ability to drive vehicles and use machines have not been studied.

Like any active product, this medicine may cause more or less troublesome effects in some people.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued 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: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website:www.signalement-sante.gouv.fr.

No cases of overdose have been reported.

Pharmacotherapeutic class: otological medicines, ATC code: S02DA01.

Preparation for auricular use combining a local antiseptic of the diamidine family (hexamidine diisethionate) and a local anaesthetic (lidocaine hydrochloride).

2 years.

To be stored at a temperature not exceeding 30°C.