FENISTIL COLD SORE Cream

Active ingredients: Penciclovir

Contraindications

Hypersensitivity to penciclovir, famciclovir or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

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.

Patient with particularly severe cold sores should be encouraged to seek medical advice.

Patients should be advised to avoid transmitting the virus, particularly when active lesions are present.

Immunocompromised patients (e.g. 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 propylene glycol, which may cause skin irritation.

Interaction with other medicinal products and other forms of interaction

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

Pregnancy and lactation

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 Fenistil 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, Fenistil 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.

Lactation

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 Fenistil Cold Sore Cream has been shown to be minimal (see Section 5.2).

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

Effects on ability to drive and use machines

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

Undesirable effects

Summary of the safety profile

Fenistil Cold Sore Cream has been well-tolerated in human studies. Clinical trial experience has shown that there was no difference between Fenistil 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); unknown (cannot be estimated from available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

General disorders and administration site condition

Common: Application site reactions (including skin burning sensation, pain of skin, hypoaesthesia)

Post-marketing surveillance has revealed the following adverse events (all reactions were either localised or generalised). Adverse events from post- marketing experience are difficult to calculate a frequency and therefore the events are listed as unknown frequency.

Immune System disorders

Not known: hypersensitivity, urticarial

Skin and subcutaneous disorders

Not known: dermatitis allergic (including rash, pruritus, blisters and oedema)

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 the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.

Incompatibilities

Not applicable.