Zovirax Eye Ointment Ref.[4774] Active ingredients: Aciclovir

Patients should be informed that transient mild stinging immediately following application may occur.

Patients should avoid wearing contact lenses when using Zovirax Eye Ointment.

No clinically significant interactions have been identified.

Pregnancy

A post-marketing aciclovir pregnancy registry has documented pregnancy outcomes in women exposed to any formulation of Zovirax. The registry findings have not shown an increase in the number of birth defects described amongst Zovirax exposed subjects compared with the general population, and any birth defects showed no uniqueness or consistent pattern to suggest a common cause.

Systemic administration of aciclovir in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rabbits, rats or mice. In a non-standard test in rats, foetal abnormalities were observed but only following such high subcutaneous doses that maternal toxicity was produced. The clinical relevance of these findings is uncertain.

The use of Zovirax Eye Ointment should be considered only when the potential benefits outweigh the possibility of unknown risks.

Breast-feeding

Limited human data show that the drug does pass into breast milk following systemic administration. However, the dosage received by the nursing infant following maternal use of Zovirax Eye Ointment would be insignificant.

Fertility

There is no information on the effect of aciclovir on human female fertility.

In a study of 20 male patients with normal sperm count, oral aciclovir administered at doses of up to 1g per day for up to six months has been shown to have no clinically significant effect on sperm count, motility or morphology.

See Clinical Studies in section 5.2.

Eye ointments can affect visual ability and therefore caution is advised when driving or using machines.

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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

None known.