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Zovirax 5% w/w Cream

  • Name:

    Zovirax 5% w/w Cream

  • Company:
    info
  • Active Ingredients:

    Aciclovir

  • 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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Summary of Product Characteristics last updated on medicines.ie: 21/7/2015
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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

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1 - 0 of 136 items.Total: Infinity pages

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

Update to MA holder contact details - Address change

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

Changed to improve readability in line with latest Quality Review Document.

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)