proximately 60% of patients started treatment at an early lesion stage (prodrome or erythema) and 40% at a late stage (papule or blister). The results were similar in both groups of patients.
5.2 Pharmacokinetic properties
Pharmacology studies have shown only minimal systemic absorption of aciclovir following repeated topical administration of Zovirax Cold Sore Cream.
Clinical Studies
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.
5.3 Preclinical safety data
The results of a wide range of mutagenicity tests in vitro and in vivo indicate that aciclovir does not pose a genetic risk to man.
Aciclovir was not found to be carcinogenic in long term studies in the rat and the mouse.
Largely reversible adverse effects on spermatogenesis in association with overall toxicity in rats and dogs have been reported 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. Pharmaceutical particulars
6.1 List of excipients
Poloxamer 407
Cetostearyl alcohol*
Sodium laurilsulfate*
White soft paraffin
Arlacel 165 (Macrogol stearate 100 and Glycerol monostearate)
Liquid paraffin
Dimeticone
Propylene glycol
Purified water
* Alternatively emulsifying wax
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months in aluminium tubes.
24 months in pump container.
6.4 Special precautions for storage
Store below 25°C, do not refrigerate.
6.5 Nature and contents of container
Zovirax Cold Sore Cream is stored in two types of container:
Aluminium tube - collapsible lacquered aluminium tubes with plastic screw caps. The tubes contain a latex end-seal at the crimped end and a membrane seal at the nozzle end. A spike is incorporated into the structure of the cap.
Pack size: 2G
Pump assembly - Polypropylene container with pump assembly and polypropylene cap.
Pack size: 2G
6.6 Special precautions for disposal and other handling
For external use only.
7. Marketing authorisation holder
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited
980 Great West Road
Brentford
Middlesex
TW8 9GS
UNITED KINGDOM
8. Marketing authorisation number(s)
PL 44673/0039
9. Date of first authorisation/renewal of the authorisation
14th May 1993 / 15th June 1999
10. Date of revision of the text
6th April 2016
11. Dosimetry
IF APPLICABLE
12. Instructions for preparation of radiopharmaceuticals
IF APPLICABLE
