Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Ocular use

Summary of the safety profile
The most common adverse drug reactions observed in clinical trials were ocular discomfort, dysgeusia and corneal deposits occurring in approximately 6%, 3% and 3% of patients, respectively.

CIL API OCT21 V3                                         Belgium update Oct 2020 Tabulated summary of adverse reactions

The following adverse reactions are ranked 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 <1/1,000), very rare (<1/10,000), or not known (cannot be determined from the available data). Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness. The adverse reactions were identified during clinical trials and post-marketing experience.

After ocular use:

System Organ Class                       MedDRA Preferred Term (v. 15.1) Immune system disorders                  Rare: hypersensitivity
Nervous system disorders                 Uncommon: headache
Rare: dizziness
Eye disorders                            Common: corneal deposits, ocular discomfort, ocular hyperaemia
Uncommon: keratopathy, punctate keratitis, corneal infiltrates, photophobia, visual acuity reduced,
eyelid oedema, blurred vision, eye pain, dry eye,
eye swelling, eye pruritus, lacrimation increased,
eye discharge, eyelid margin crusting, eyelid exfoliation, conjunctival oedema, erythema of eyelid
Rare: ocular toxicity, keratitis, conjunctivitis,
corneal epithelium defect, diplopia, hypoaesthesia eye, asthenopia, hordeolum, eye irritation, eye inflammation
Ear and labyrinth disorders              Rare: ear pain
Respiratory, thoracic and mediastinal    Rare: paranasal sinus hypersecretion, rhinitis disorders
Gastrointestinal disorders               Common: dysgeusia
Uncommon: nausea
Rare: diarrhoea, abdominal pain
Skin and subcutaneous tissue disorders   Rare: dermatitis
Musculoskeletal and connective tissue    Not known: tendon disorder disorders

Paediatric patients
The safety and efficacy of CILOXAN were determined in 230 children aged between 0 and 12 years.
No serious adverse reactions have been reported in this patient population.

CIL API OCT21 V3                                    Belgium update Oct 2020 Otic use
The most common adverse drug reactions observed in clinical trials were ear pruritus and otorrhoea, occurring in approximately 1% of patients.

Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness. The adverse reactions were identified during clinical trials and post-marketing experience. For a description of the frequency conventions, see above.

After otic use:

System Organ Class                          MedDRA Preferred Term (v. 15.1) Nervous system disorders                    Uncommon: headache
Ear and labyrinth disorders                 Uncommon: ear pain, ear congestion, otorrhoea, ear pruritus
Not known: tinnitus
Skin and subcutaneous tissue disorders      Uncommon: dermatitis
General disorders and administration site   Uncommon: pyrexia conditions

Paediatric patients
The safety and efficacy of CILOXAN were determined in 193 children aged between 0 and 12 years.
No serious adverse reactions have been reported in this patient population.

Description of selected adverse reactions
Ocular use
With topically applied fluoroquinolones, (generalised) rash, toxic epidermolysis, dermatitis exfoliative, Stevens-Johnson syndrome and urticaria occur very rarely. In isolated cases, blurred vision, decreased visual acuity and medication residue have been observed with ophthalmic ciprofloxacin.

A white topical ocular precipitate (medication residue) was observed in patients with corneal ulcer and frequent administration of CILOXAN eye drops. This resolved after further administration of CILOXAN eye drops. This precipitate does not preclude continued use of this product and does not adversely effect the clinical course of the recovery process.

Otic use
The ingredients rarely cause hypersensitivity with otic use. However, as with any substance applied to the skin, an allergic reaction to one of the components of the medicinal product is always possible.

Ocular and otic use
Serious and occasionally fatal (anaphylactic) hypersensitivity reactions, some following the first dose, have been observed in patients receiving systemic quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial oedema, dyspnoea, urticaria and itching.

Ruptures of the Achilles, shoulder, hand 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 such tendon ruptures may be increased in patients receiving corticosteroids, especially in geriatric patients and in tendons under high stress, including the Achilles tendon. To date, clinical and post-marketing data have not demonstrated a clear association between topical CILOXAN and musculoskeletal and connective tissue adverse reactions.
CIL API OCT21 V3                                         Belgium update Oct 2020 Moderate to severe phototoxicity has been observed in patients treated with systemic quinolones.
Nevertheless, phototoxic reactions to ciprofloxacin are uncommon.

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