Adverse reactions : תופעות לוואי

4.8   Undesirable Effects
Adverse reactions are listed below by MedDRA body system organ class and by frequency.

The frequency categories used are:

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.
Clinical trial data have been used to assign frequency categories to adverse reactions observed during clinical trials with aciclovir 3% ophthalmic ointment. Due to the nature of the adverse events observed, it is not possible to determine which events were related to the administration of the drug and which were related to the disease. Spontaneous reporting data has been used as a basis for allocating frequency for those events observed post-marketing.

Immune system disorders:

Very rare:         Immediate hypersensitivity reactions including angioedema and urticaria.

Eye disorders:

Very common:       Superficial punctate keratopathy.
This did not necessitate an early termination of therapy and healed without apparent sequelae.

Common:            Transient mild stinging of the eye occurring immediately following application, 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. Healthcare professionals are asked to report any suspected adverse reactions.