Adverse reactions : תופעות לוואי

4.8     Undesirable effects
Summary of the safety profile

In clinical trials using IOPIDINE the most common adverse reactions were ocular hyperaemia, eye pruritus, and conjunctivitis, occurring in approximately 12% to 23% of patients.

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, adverse reactions are presented in order of decreasing seriousness.

System Organ Classification              MedDRA Preferred Term (v. 19.0) Infections and infestations              Common: rhinitis
Immune system disorders                  Not known: hypersensitivity
Psychiatric disorders                    Uncommon: depression, nervousness, insomnia Nervous system disorders                 Common: headache, dysgeusia
Uncommon: dizziness, abnormal coordination, somnolence,
paraesthesia
Eye disorders                            Very common: conjunctivitis, eye pruritus, ocular hyperaemia Common: eyelid oedema, dry eye, conjunctival follicles, foreign body sensation in eyes, eyelid margin crusting,
lacrimation increased, ocular discomfort
Uncommon: mydriasis, keratitis, keratopathy, visual acuity reduced, visual impairment, photophobia,
vision blurred, corneal erosion, corneal infiltrates, blepharospasm, blepharitis, eyelid ptosis, erythema of eyelid, eye pain, eye oedema, eyelid disorder, eyelid scales, eyelid retraction, conjunctival vascular disorders,
conjunctival oedema, eye discharge, eye irritation
Cardiac disorders                        Uncommon: chest pain, oedema peripheral, arrhythmia 
Vascular disorders                       Uncommon: vasodilation
Respiratory, thoracic and mediastinal    Common: nasal dryness disorders                                Uncommon: asthma, dyspnoea, rhinorrhoea, parosmia, throat irritation
Gastrointestinal disorders               Common: dry mouth
Uncommon: nausea, constipation
Skin and subcutaneous tissue             Common: dermatitis disorders                                Uncommon: dermatitis contact, face oedema Muscoskeletal and connective tissue      Uncommon: myalgia disorders
General disorders and administration     Common : asthenia site conditions                          Uncommon: malaise, fatigue, irritability Investigations                           Uncommon: corneal staining

Description of selected adverse reactions

Use of IOPIDINE 0.5% can lead to an ocular intolerance reaction (see section 4.4). The mean onset time of these reactions was 44 days (range 1‐127 days).

In clinical studies, the overall discontinuation rate related to IOPIDINE 0.5% was 15%. The most commonly reported events leading to discontinuation included (in decreasing order of frequency) ocular hyperaemia, eye pruritus, lacrimation increased, ocular discomfort, eyelid oedema, dry mouth, and abnormal sensation in eye.

The possibility of bradycardia based on apraclonidine’s alpha‐2‐adrenergic agonist effect should be considered.
Although there were no reports of bradycardia related to IOPIDINE 0.5% Eye Drops from clinical studies, occasional reports have been received through post‐marketing surveillance.

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