When a pharmaceutical company changes an SPC or PIL, 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.
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)
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)
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.