Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
In clinical studies involving 2,252 patients, VIGAMOX was administered up to 8 times a day, with over 1,900 of these patients receiving treatment 3 times daily. The overall safety population that received the medicinal product consisted of 1,389 patients from the United States and Canada, 586 patients from Japan and 277 patients from India. No serious ophthalmic or systemic undesirable effects related to the medicinal product were reported in any of the clinical studies. The most frequently reported treatment-related undesirable effects with the medicinal product were eye irritation and eye pain, occurring at an overall incidence of 1 to 2%. These reactions were mild in 96% of those patients who experienced them, with only 1 patient discontinuing therapy as a result.

Tabulated summary of adverse reactions
The following adverse reactions are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) or not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in decreasing order of seriousness.

System Organ Classification       Frequency                    Adverse reactions Blood and lymphatic system        Rare                         haemoglobin decreased disorders
Immune system disorders           Not known                    hypersensitivity Nervous system disorders          Uncommon                     headache Rare                         paresthesia
Not known                    dizziness
Eye disorders                     Common                       eye pain, eye irritation Uncommon                     punctate keratitis, dry eye,
conjunctival haemorrhage,
ocular hyperaemia, eye pruritus, eyelid oedema,
ocular discomfort,
Rare                         corneal epithelium defect,
corneal disorder,
conjunctivitis, blepharitis,
eye swelling, conjunctival oedema, vision blurred,
visual acuity reduced,
asthenopia, erythema of eyelid
Not known                    endophthalmitis, ulcerative keratitis, corneal erosion,
corneal abrasion, intraocular pressure increased, corneal opacity, corneal infiltrates,
corneal deposits, eye allergy,
keratitis, corneal oedema,
photophobia, eyelid oedema,
lacrimation increased, eye discharge, foreign body sensation in eyes


Cardiac disorders                 Not known                     palpitations Respiratory, thoracic and         Rare                          nasal discomfort, mediastinal disorders                                           pharyngolaryngeal pain, sensation of foreign body
(throat)
Not known                     dyspnoea
Gastrointestional disorders       Rare                          vomiting Uncommon                      dysgeusia
Not known                     nausea
Hepatobiliary disorders           Rare                          alanine aminotransferase increased, gamma- glutamyltransferase increased
Skin and subcutaneous tissue      Not known                     erythema, rash, pruritus, disorders                                                       urticaria 

Description of selected adverse reactions
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following 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 (see section 4.4).

Ruptures of the shoulder, hand, Achilles, 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 quinolones indicate that a risk of these ruptures may be increased in patients receiving corticosteroids, especially geriatric patients and in tendons under high stress, including Achilles tendon (see section 4.4).

Paediatric population
In clinical trials, VIGAMOX has shown to be safe in paediatric patients, including neonates.
In patients under 18 years old, the two most frequent adverse reactions were eye irritation and eye pain, both occurring at an incidence rate of 0.9%.
Based on data from clinical trials involving paediatric patients, including neonates (see section 5.1), the type and severity of adverse reactions in the paediatric population are similar to those in adults.


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