Zovirax 5% w/w Cream
- Name:
Zovirax 5% w/w Cream
- 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: 30/01/19
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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
GlaxoSmithKline (Ireland) Ltd
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Company Products
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 30 January 2019 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
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 18 November 2011 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 21 January 2010 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Zovirax 5% w/w Cream (PA 1077/84/1)
Summary of changes due to the approval of the Renewal on 23/10/2009
Please note that the name change to the SPC and PL described below must be made also to the medicines.ie entry for this product, currently listed as ‘Zovirax Cream’
SPC UPDATES
Section 1 NAME OF THE MEDICINAL PRODUCT
Changed from Zovirax Cream 5% w/w to (i.e. name, strength, dosage form):
Zovirax 5% w/w Cream
Section 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Added quantitative description of the excipients propylene glycol (40% w/w) and cetostearyl alcohol (6/75% w/w)
Updated on 18 January 2010 PIL
Reasons for updating
- Change of trade or active ingredient name
- Change of inactive ingredient
- Change to storage instructions
- Change to how the medicine works
Updated on 7 August 2007 PIL
Reasons for updating
- Change of inactive ingredient
Updated on 14 June 2007 SmPC
Reasons for updating
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
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.
6.1 List of Excipients
Cetostearyl alcohol
Liquid paraffin
Poloxamer 407
Propylene glycol
Purified water
Sodium laurilsulfate
White soft paraffin
Dimeticone 20
Glycerol Monostearate / Macrogol Stearate (Arlacel 165)
Updated on 19 October 2006 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.2 Posology and Method of Administration
Zovirax Cream should be applied five times daily at approximately four hourly intervals omitting the night time application.
Zovirax Cream should be applied to the lesions or impending lesions as soon as possible preferably during the earliest stages (prodrome or erythema). Treatment can also be started during the later (papule or blister) stages.
Treatment should be continued for at least four days for herpes labialis and for five days for genital herpes. If healing has not occurred, treatment may be continued for up to ten days.
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 4 August 2005 PIL
Reasons for updating
- Improved electronic presentation
Updated on 17 August 2004 PIL
Reasons for updating
- New PIL for medicines.ie
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)