Zovirax® 30 mg/g Eye Ointment
- Name:
Zovirax® 30 mg/g Eye Ointment
- Company:
GlaxoSmithKline (Ireland) Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/07/15

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GlaxoSmithKline (Ireland) Ltd
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 2 July 2019 SmPC
Reasons for updating
- File format updated to PDF
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
File format updated from word to PDF. Approval date of SPC 20 June 2018.
Updated on 22 June 2018 SmPC
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
- Improved presentation of SmPC
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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.
Updated on 21 July 2015 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 21 July 2015 SmPC
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to MA holder contact details
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 20 July 2015 PIL
Reasons for updating
- New PIL for new product
Updated on 20 July 2015 PIL
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 10 June 2015 SmPC
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to improve clarity and readability
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 9 June 2015 PIL
Reasons for updating
- Change to date of revision
- Change to improve clarity and readability
Updated on 11 October 2012 SmPC
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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
Updated on 5 October 2012 PIL
Reasons for updating
- Change due to harmonisation of PIL
Updated on 21 November 2011 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 14 June 2007 SmPC
Reasons for updating
- Change to section 5.3 - Preclinical safety data
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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.
Updated on 26 February 2007 PIL
Reasons for updating
- Change to date of revision
Updated on 1 September 2006 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 1 June 2005 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 22 December 2004 SmPC
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 16 December 2004 SmPC
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 7 January 2004 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 7 July 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)