CETRAXAL Ear drops Ref.[6737] Active ingredients: Ciprofloxacin

This medicinal product is for auricular use, not for ophthalmic use, inhalation or injection.

In otic use meticulous medical monitoring is required in order to be able to determine in a timely manner the possible necessity of other therapeutic measures.

Paediatric population

The safety and efficacy of this product have been established in paediatric patients 1 year and older in controlled clinical trials. Although very limited data are available in patients less than age 1 year treated for acute otitis externa, there are no differences in the disease process itself, in this patient population, which would preclude use of this product in patients less than one year of age. Based upon the very limited data, the prescribing physician should weigh the clinical benefits of use against the known and possibly unknown risks when prescribing in patients less than age 1 year.

The safety and efficacy of Cetraxal have not been studied in the presence of a perforated tympanic membrane. Therefore, Cetraxal should be used with caution in patients with known or suspected perforation, or where there is a risk of perforation of the tympanic membrane.

Cetraxal should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones. Serious acute hypersensitivity reactions may require immediate emergency treatment.

As with other antibiotic preparation, the use of this product may result in overgrowth of non-susceptible organisms, including bacterial strains, yeast and fungi. If superinfection occurs, appropriate therapy should be initiated.

If after one week of therapy some signs and symptoms persist, further evaluation is recommended to reassess the disease and the treatment.

Some patients taking systemic quinolones have shown moderate to severe skin sensitivity to sun. Due to the site of administration, it is unlikely that this product may show photoallergic reactions.

No interaction studies have been performed with Cetraxal.

Due to low plasma level anticipated after application in the ear, it is unlikely that ciprofloxacin may show systemic interaction with other drugs.

It is recommended not to use other ear preparations concomitantly.

Pregnancy

There are no data on the use of ciprofloxacin otic solution 0.2% in pregnant women. There are moderate amount of data from the use oral ciprofloxacin in pregnant women. No reproductive toxicity has been performed after otic administration. However after systemic exposure, animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

Since systemic exposure to ciprofloxacin is negligible after otic administration, thus no effects are anticipated during pregnancy. Cetraxal can be used during pregnancy.

Lactation

Ciprofloxacin is excreted in human milk after systemic use. It is not known whether ciprofloxacin is excreted in human milk after otic use. No effects on the breast-fed newborn are anticipated since the systemic exposure of the breast-feeding woman to ciprofloxacin is negligible. Cetraxal can be used during breast-feeding.

Fertility

Studies in animals with oral administration of ciprofloxacin do not indicate any effects on fertility.

Cetraxal has no or negligible influence on the ability to drive and use machines.

In a Phase III clinical trial, a total of 319 patients were treated with Cetraxal.

The most commonly reported adverse reactions are: ear pruritus occurring in 0.9% of patients treated with ciprofloxacin, and headache and application site pain, both occurring in approximately 0.6 % of patients.

All treatment related adverse reactions are uncommon (≥1/1000 to <1/100) and are listed below.

Ear and Labyrinth Disorders

Uncommon: Ear pruritus, tinnitus

Nervous System Disorders

Uncommon: Dizziness, headache

Skin and subcutaneous disorders

Uncommon: Dermatitis

General Disorders and Administration Site Conditions

Uncommon: Application Site Pain

With locally applied fluoroquinolones (generalized) rash, toxic epidermolysis, dermatitis exfoliative, Stevens-Johnson syndrome, and urticaria occur very rarely.

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 Yellow Card Scheme (www.mhra.gov.uk/yellowcard).

Not applicable.