CETRAXAL PLUS

Posology Adults and elderly population Acute otitis externa and acute otitis media with tympanostomy tubes: Instil the contents of one single-dose container into the affected ear canal every 12 hours for 7 days. No overall differences in safety and effectiveness have been observed between elderly and other adult patients.

Renal/ hepatic impairment No dosage adjustment is deemed necessary. Paediatric population The dosage in children aged 6 months and older is the same as for adults for both indications. 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 for patients with otitis externa 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.

Tabulated summary of adverse events The following adverse reactions listed in the table below were observed in clinical studies or with post-marketing experience. They are ranked according to system organ class and classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), or not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 4) Vascular disorders Uncommon: flushing Gastrointestinal disorders Uncommon: vomiting Skin and subcutaneous tissue disorders Uncommon: skin exfoliation, rash erythematous, rash, granulation tissue General disorders and administration site conditions Uncommon: irritability, fatigue Investigations Uncommon: medication residue Injury, poisoning and procedural complications Uncommon: device occlusion (tympanostomy tube obstruction) Description of selected adverse reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolone therapy.

Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial oedema), airway obstruction, dyspnoea, urticaria, and itching. Ruptures of the shoulder, hand, Achiles or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving systemic fluoroquinolones.

Studies and post marketing experience with systemic fluoroquinolones indicate that the risk of these ruptures may be increased in patients receiving corticosteroids, especially geriatric patients and in tendons under high stress, including the Achiles tendon.

To date, clinical and post marketing data have not demonstrated a clear association between otic administration of ciprofloxacin and these musculoskeletal and connective tissue adverse reactions. Paediatric population Cetraxal Plus has been shown to be safe in paediatric patients 6 months of age or older.

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 [TO BE COMPLETED NATIONALLY].

4 Special warnings and special precautions for use This medicinal product is for auricular use only, not for ophthalmic use, inhalation or injection. This medicine should not be swallowed or injected. If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumour.

If after the treatment some signs and symptoms persist, further evaluation is recommended to reassess the disease and the treatment. Cetraxal Plus 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 preparations, 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. 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 produce photoallergic reactions. Corticosteroids may reduce resistance to, and aid in, the establishment of bacterial, viral, or fungal infections and mask the clinical signs of an infection, preventing recognition of ineffectiveness of the antibiotic, or may suppress hypersensitivity reactions to substances in the product.

Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Paediatric population Safety and efficacy of Cetraxal Plus have not been established in children younger than 6 months. Under exceptional circumstances, Cetraxal Plus treatment could be used in this sub-paediatric population after a very careful benefit/risk evaluation by the prescribing physician taking into account that although there are no known safety concerns or differences in disease process to preclude use in these children, clinical experience is insufficient in these specific subgroups of paediatric population.

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