Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
The most common adverse reactions are eye pain, ocular hyperaemia, eye pruritus, lacrimation increased, blurred vision or eye irritation. The majority of these adverse reactions are transient and most are mild or moderate.

Tabulated list of adverse reactions
The following adverse reactions were reported during clinical trials and the French NPU programme with Cystadrops. Reported adverse reactions are listed below, by system organ class and by frequency (by patient).
Frequencies are defined as: 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), not known (cannot be estimated from the available data).

System organ class                      Adverse reactions
Very common : eye pain, vision blurred, eye irritation, ocular
Eye disorders hyperaemia, eye pruritus, lacrimation increased, deposit eye
Common : abnormal sensation in eye, dry eye, foreign body sensation in eye, eyelid oedema, eyelid irritation, visual impairment, hordeolum

General disorders and administration Very common : instillation site discomfort (mainly sticky eyes site conditions                      and sticky eyelashes)
Common : instillation site pain


Paediatric population
Frequency, type and severity of adverse reactions in children are the same as in adults.
69 paediatric patients were followed through clinical trials and the French NPU programme. 19 patients were under 6 years old, 21 between 6 and 12 years old and 29 between 12 and 18 years old.


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/