Adverse reactions : תופעות לוואי

4.8   Undesirable effects

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.


System Organ Classification                     MedDRA Preferred Term Uncommon: candidiasis, ear infection
Infections and infestations fungal, contralateral otitis media
Common: dysgeusia
Nervous system disorders                        Uncommon: paraesthesia (tingling in ears), dizziness, headache, crying
Common: ear pain, ear discomfort, ear pruritus
Ear and labyrinth disorders                     Uncommon: hypoacusis, tinnitus, otorrhoea, ear congestion, tympanic membrane disorder, auricular swelling
Not known: Vision, blurred (see also
Eye disorders section 4.4)
Vascular disorders                              Uncommon: flushing Gastrointestinal disorders                      Uncommon: vomiting Uncommon: skin exfoliation, rash
Skin and subcutaneous tissue disorders erythematous, rash, granulation tissue
General disorders and                           Uncommon: irritability, fatigue administration site conditions
Investigations                                  Uncommon: medication residue Injury, poisoning and procedural                Uncommon: device occlusion complications                                   (tympanostomy tube obstruction) Immune system disorders                         Unknown: allergic reaction 

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 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.
Any suspected adverse events should be reported to the ministry of health according to the national regulation by using an online form: https://sideeffects.health.gov.il/