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Cetraxal® (ciprofloxacin 2mg/ml ear drops solution)

Product DescriptionCetraxal (ciprofloxacin 2mg/ml ear drops)
Strength 2mg/ml
Pack Size15 single-dose ampoules, 0.25ml of solution in each
Legal CategoryPOM
PIP Code406-3566
EAN Code5060209731827
List Price£6.01
Aspire Pharma Product Code1010385
IndicationAcute otitis externa in adults and children older than 1 year with an intact tympanic membrane, caused by ciprofloxacin susceptible microorganisms.

Cetraxal (ciprofloxacin) 2mg/ml ear drops solution in a single-dose container Prescribing Information
(please refer to the full SmPC before prescribing)

Indication: Acute otitis externa in adults and children older than 1 year with an intact tympanic membrane, caused by ciprofloxacin susceptible microorganisms. Composition: Each ampoule delivers 0.50 mg ciprofloxacin as hydrochloride, contained in 0.25ml of solution. Please refer to the Summary of Product Characteristics (SmPC) for a full list of excipients. Method of administration: Adults and children aged one year and older: Instillation of the contents of a single ampoule into the affected ear twice daily for seven days. Children aged less than one year: The safety and efficacy of Cetraxal has not been established. For details of the method of administration please refer to the SmPC. If an otowick/tampon is used to facilitate administration, the first dose should be doubled to two ampoules. Use immediately after opening the ampoule. Discard any unused contents. No dosage adjustment is required in those with renal or hepatic impairment. Contraindications: Hypersensitivity to ciprofloxacin, any member of the quinolone class of antimicrobials or listed excipients. Special warnings and precautions for use: Not for ophthalmic use, inhalation or injection. Monitor use carefully to determine if other therapeutic measures may be required. If after one week of therapy signs and symptoms persist, further re-evaluation should occur. In children aged less than one-year old, the physician should weigh the clinical benefits of use against known and unknown risks. Use with caution in patients with a known or suspected perforated tympanic membrane and where there is a risk of

perforation. Discontinue use at first appearance of a skin rash or any other sign of hypersensitivity. Some patients taking systemic quinolones have shown moderate to severe skin sensitivity to the sun. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose of a systemic quinolone. Serious acute hypersensitivity reactions may require immediate emergency treatment. Overgrowth of non-susceptible organisms may occur from use of this product including bacterial strains, yeast and fungi. If superinfection occurs, appropriate therapy should be started. Interactions with other medicinal products: No interaction studies have been performed. Due to low plasma levels, it is unlikely that Cetraxal will show systemic interactions with other drugs. It is recommended not to use other ear preparations concomitantly. Pregnancy and lactation: Cetraxal can be used during pregnancy and breast-feeding. Effects on ability to drive and use machines: None or negligible. Undesirable effects: Ear pruritis, headache, application site pain, tinnitus, dizziness, dermatitis. Rarely with locally applied fluoroquinolones: rash, toxic epidermolysis, exfoliative dermatitis, Stevens-Johnson syndrome, urticaria. MAH: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom MA number: PL35533/0130. Cost: Per pack of 15 ampoules £6.01 Legal Category: POM. Date of Prescribing Information: 01.11.2017
CET/UK/171102 | November 2017

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Aspire Pharma Ltd on 01730 231148

CET/UK/180101 | January 2018