File format updated from word to PDF.  Approval date of SPC 20 June 2018. 

To bring the SPC description of the tube in line with the registered module 3 details and actual tube composition, by amending the wording in Section 6.5 to “White to pale yellow sterile ointment contained in a multilayer aluminium laminate tube with a tamper evident screw cap”.

This opportunity has also been taken to make a number of editorial and typographical amendments to the IE SPC, as described below:

Section 1: Removal of ® symbol from Product Name
Section 4.3: Change from ‘and’ to ‘or’ in sentence “Zovirax eye Ointment is contraindicated in patients known to be hypersensitive to aciclovir or valaciclovir, or any of the excipients as listed in section 6.1.”
Section 4.6 : Removal of sentence beginning “Experience in humans is limited…“, and re-positioning of the sentence “The use of Zovirax Eye Ointment should be considered only when the potential benefits outweigh the possibility of unknown risks.” from the beginning to the end of the Pregnancy sub-section 
Section 9: Addition of sub-headings – “Date of first authorisation:/Date of latest renewal:“, to achieve alignment with EMA QRD Template.

Changes to:

Section 4.3  - Contraindications,

Section 4.4  - Special warnings and precautions for use,

Section 4.6  - Pregnancy and lactation,

Section 5.3  - Preclinical safety data

5.3       Preclinical Safety Data

There is no information on the effect of aciclovir oral formulations or i.v. for infusion 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.

NON-CLINICAL INFORMATION

     Mutagenicity

The results of a wide range of mutagenicity tests in vitro and in vivo indicate that acyclovir does not is unlikely to pose a genetic risk to man.

     Carcinogenicity

Aciclovir was not found to be carcinogenic in long-term studies in the rat and the mouse.

     Fertility

Largely reversible adverse effects on spermatogenesis in association with overall toxicity in rats and dogs have been reported only at systemic doses of aciclovir greatly in excess of those employed therapeutically. Two-generation studies in mice did not reveal any effect of (orally administered) aciclovir on fertility.