VECTAVIR Cream Ref.[50416] Active ingredients: Penciclovir

The cream should only be used on cold sores on the lips and around the mouth. It is not recommended for application to mucous membranes (e.g. in the eyes, mouth, or nose or on the genitals). Particular care should be taken to avoid application in or near the eyes.

Severely immunocompromised patients (eg AIDs patients or bone marrow transplant recipients) should be encouraged to consult a physician in case oral therapy is indicated.

The cream contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis). It also contains 416 mg of propylene glycol per gram of cream, which may cause skin irritation.

Clinical trial experience has not identified any interactions resulting from concomitant administration of topical or systemic drugs with Vectavir Cold Sore Cream.

Pregnancy

There is unlikely to be any cause for concern regarding adverse effects when the cream is used in pregnant women as systemic absorption of penciclovir following topical administration of Vectavir Cold Sore Cream has been shown to be minimal (see Section 5.2).

Since the safety of penciclovir in human pregnancy has not been established, Vectavir Cold Sore Cream should only be used during pregnancy or in nursing mothers on the advice of a doctor, if the potential benefits are considered to outweigh the potential risks associated with treatment.

Breast feeding

There is unlikely to be any cause for concern regarding adverse effects when the cream is used in lactating women as systemic absorption of penciclovir following topical administration of Vectavir Cold Sore Cream has been shown to be minimal (see Section 5.2).

There is no information on excretion of penciclovir in human milk.

Vectavir Cold Sore Cream has no influence on the ability to drive and use machines.

Summary of the safety profile

Vectavir Cold Sore Cream has been well-tolerated in human studies. Clinical trial experience has shown that there was no difference between Vectavir Cold Sore Cream and placebo in the rate or type of adverse reactions reported. The most common events are application site adverse events.

Tabulated list of adverse reactions

Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1,000 to <1/100); rare (>1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via: HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@hpra.ie.

Not applicable.