CETRAXAL PLUS EAR DROPS SOLUTION [SIN14597P]

Product Info

CETRAXAL PLUS EAR DROPS SOLUTION

[SIN14597P]

4.1 Therapeutic indications

Cetraxal Plus is indicated in adults and in children aged 6 months and older for the following infections:

• Acute otitis externa (AOE)

• Acute otitis media in patients with tympanostomy tubes (AOMT)

Caused by ciprofloxacin susceptible microorganisms (see sections 4.2, 4.4 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology and method of administration

Posology

Adults and elderly population

Acute otitis externa and acute otitis media with tympanostomy tubes: Instil 6–8 drops into the affected external ear canal every 12 hours for 7 days.

No overall differences in safety and effectiveness have been observed between elderly and other adult patients.

Paediatric population

The dosage in children aged 6 months and older is the same as for adults for both indications.

Renal/hepatic impairment

No dosage adjustment is deemed necessary.

Method of administration

Auricular use.

Precautions to be taken before handling or administering the medicinal product

The solution should be warmed before its use, by holding the bottle in the hand for several minutes. This will avoid the discomfort that may result from the instillation of a cold solution into the ear canal. The patient should lie with the affected ear upward and then the drops should be instilled pulling several times on the auricle. For patients with acute otitis media with tympanostomy tubes, the tragus should be pumped 4 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for around 1 minute to facilitate penetration of the drops into the ear.

Repeat, if necessary, for the opposite ear.

To prevent contamination of the dropper tip in order to limit bacterial risks, care should be taken not to touch the auricle or the external ear canal and surrounding areas, or other surfaces with the dropper tip of the bottle. Keep the bottle tightly closed when not in use. Keep the bottle until the completion of the treatment.

4.3 Contraindications

• Hypersensitivity to the active substances ciprofloxacin or fluocinolone acetonide or any member of the quinolone class of antimicrobial agents or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Viral infections of the external ear canal, including varicella and herpes simplex infections and fungal otic infections.