Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Adverse reactions are listed below according to the MedDRA system organ classification and frequency.

The following terminology is used to classify adverse reactions by frequency: very common (> 1/10), common (> 1/100 to <1/10), uncommon (> 1/1000 to <1/100) , rare (> 1 / 10 000 to <1/1000), very rare (<1 / 10 000).

The adverse reactions are presented by frequency based on clinical trial data with aciclovir eye ointment. Due to the nature of the observed adverse reactions, it is not possible to determine unequivocally which reactions are related to drug administration and which are disease related. Data from spontaneous reporting have been used to determine the incidence of adverse reactions observed in the post-marketing period.

Immune system disorders
Very rare: immediate hypersensitivity reactions, incl. angioedema and urticaria.
Eye disorders
2
Very common: superficial punctate keratopathy
It does not require early cessation of treatment and resolves without complications.

Common: transient mild burning sensation in the eyes immediately after administration, conjunctivitis.
Rare: blepharitis.
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.