Contains 5% w/w Aciclovir PhEur.

White to off-white cream.

1) Treatment of herpes simplex virus infections of the skin including initial and recurrent genital herpes and herpes labialis.

Aciclovir Cream should be applied to the lesion or impending lesion as early as possible after the start of an infection. It is particularly important to start treatment of recurrent episodes during the prodromal period or when lesions first appear.

Adults (including elderly): Aciclovir Cream should be applied five times daily at approximately four hourly intervals, omitting the night time application. Treatment should be continued for five days. If, after five days, healing is not complete then treatment can be continued for up to an additional five days.

Hypersensitivity to aciclovir or any ingredients in the formulation; do not use in eyes.

In severely immunocompromised patients (eg AIDS patients or bone marrow transplant recipients) oral Aciclovir dosing should be considered. Such patients should be encouraged to consult a physician concerning the treatment of any infection.

Aciclovir Cream is not recommended for application to mucous membranes such as in the mouth, eye or vagina, as it may be irritant.

Particular care should be taken to avoid accidental introduction into the eye. Largely reversible adverse effects on spermatogenesis in association with overall toxicity in rats and dogs have been reported only at doses of Aciclovir greatly in excess of those employed therapeutically. There has been no experience of the effect of Aciclovir Cream on human fertility. Two generation studies in mice did not reveal any effect of (orally administered) Aciclovir on fertility. Aciclovir Tablets have been shown to have no definite effect upon sperm count, morphology or motility in man.

Probenecid increases the mean half-life and area under the plasma concentration curve of systematically administered Aciclovir. However, this is likely to be of little relevance to the topical application of Aciclovir.

Transient burning or stinging following application of Aciclovir Cream may occur in some patients. Mild drying or flaking of the skin has occurred in 5% of patients. Erythema and itching has been reported in a small proportion of patients.

Contact dermatitis has been reported rarely following application. Where sensitivity tests have been conducted the reactive substances have most often been shown to be components of the cream base rather than aciclovir.

Actavis UK Ltd

POM – Prescription Only Medicine

15 September 2010