Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical trials and spontaneous reporting.
Based on pooled data from clinical studies, including 2,499 patients with eye infections including acute conjunctivitis, who received Fucithalmic eye drops, the frequency of undesirable effects was 11.3%.

The most frequently reported adverse reactions during treatment are various application site reactions such as pain, pruritus and irritation/discomfort in/around the eyes, which occurred in approximately 8.5% of patients, followed by blurring of vision, which occurred in approximately 1.2% of patients. Angioedema has been reported in a few patients post marketing.

Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.

Very common (≥1/10)
Common (≥1/100 and <1/10)
Uncommon (≥1/1,000 and <1/100)
Rare (≥1/10,000 and <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)
System organ class         Frequency       Undesirable effects Immune system              Uncommon        Hypersensitivity disorders
Eye Disorders              Common          Vision blurred (transient) 
Uncommon        Eyelid oedema, Lacrimation increased

Rare            Conjunctivitis aggravated
Skin and subcutaneous      Uncommon        Rash tissue disorders                           Angioedema
Rare            Urticaria
General disorders and      Common          Application site pain (including eye burning administration site                        and eye stinging) conditions                                 Application site pruritus Application site discomfort/irritation


Paediatric population
The observed safety profile is similar in children and adults.
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