XOROX Eye ointment Ref.[51142] Active ingredients: Aciclovir

For ocular use only. Not for injection or oral intake.

There is insufficient clinical data on the use of Xorox eye ointment for deep corneal defects and the combined use of Xorox eye ointment with topical corticosteroids.

In case of a bacterial coinfection, an additional antibiotic therapy must be carried out.

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

Patients should avoid wearing contact lenses when using Xorox eye ointment.

No clinically significant interactions have been identified when applied topically.

Fertility

No studies have been performed to investigate the effect of topically ophthalmic use of aciclovir on 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. With the recommended use of Xorox , the systemic exposure of aciclovir is expected to be negligible and no risk is anticipated.

Pregnancy

A post-marketing aciclovir pregnancy registry has documented pregnancy outcomes in women exposed to aciclovir. The registry findings have not shown an increase in the number of birth defects described amongst aciclovir 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.

With the recommended use of Xorox no effects during pregnancy are anticipated since systemic exposure of aciclovir is expected to be negligible. When necessary, Xorox eye ointment can be used during pregnancy.

Breast Feeding

Limited 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 Xorox eye ointment would be insignificant. The use of Xorox eye ointment can be considered during breast feeding.

No studies on the effects on the ability to drive and use machines have been performed. Xorox eye ointment can affect visual ability and therefore caution is advised when driving or using machines.

Immediately after the application of the ophthalmic ointment, a temporary slight pricking or burning may occur but this may not interfere with the treatment. Serious side effects after the use of systemically applied aciclovir are rare and most of the symptoms are reversible.

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 (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000), very rare: (<1/10,000), Not known: frequency cannot be estimated from the available data.

Due to the nature of the side effects, it is not possible to clearly determine whether these reactions were caused by the disease or the administration of the drug. Post-marketing spontaneous reports served as the basis for assigning frequencies of side effects.

Immune system disorders

Very rare: Immediate hypersensitivity reactions, including angioedema (Quincke’s oedema, pale swelling of the skin especially in the face) and urticaria (hives)

Eye disorders

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

Uncommon: Transient mild stinging or burning 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 national reporting system: ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal.

Not applicable.