Vectavir 1% - cream for the treatment of herpes labialis 2 g

Product Description

Active substances

Each gram of cream contains 10 mg of penciclovir. Excipients with known effect: 77.2 mg of cetostearyl alcohol, 416.8 mg of propylene glycol. For the full list of excipients, see section 6.1.

Excipients

Solid paraffin Liquid paraffin Cetostearyl alcohol Propylene glycol Cetomacrogol 1000 Purified water Vectavir is indicated for the treatment of herpes labialis.

Contraindications

Hypersensitivity to the active substance penciclovir, to famciclovir or to any of the excipients listed in section 6.1. Children under 12 years of age.

Dosage

Adults (including the elderly) and children over 12 years of age: VECTAVIR should be applied at approximately 2-hourly intervals throughout the day. Treatment, which should continue for 4 days, should be started as soon as possible, at the first sign of infection. However, even in patients who start therapy later, VECTAVIR has been shown to be effective in accelerating healing of lesions, reducing pain associated with them and shortening the time of viral shedding. Application instructions VECTAVIR should be applied, in an amount appropriate to the size of the area to be treated, with a clean finger or with a disposable applicator that must be discarded after use [for packs containing applicators]. Paediatric population Children (under 12 years of age): Vectavir is not recommended for use in children under 12 years of age due to a lack of data on safety and/or efficacy.

Storage

Do not store above 30°C.
Do not freeze.

Warnings

The cream should only be applied to lesions on the lips and around the mouth. Application to mucous membranes (e.g., in the eyes, mouth or nose, or on the genitals) is not recommended. Particular care should be taken to avoid application in or near the eyes. Severely immunocompromised patients (e.g., patients with AIDS or bone marrow transplant recipients) should be encouraged to consult a physician if oral therapy is indicated. Vectavir contains cetostearyl alcohol: may cause allergic reactions. Vectavir may cause local skin reactions (e.g. contact dermatitis). Vectavir contains propylene glycol: may cause skin irritation.

Effects

Vectavir cream was well tolerated in human studies. Experience from clinical trials has shown that there is no difference in the frequency or type of adverse reactions between Vectavir cream and placebo. The most common events are application site adverse events. Adverse reactions are listed below by system organ class, class, and frequency. Frequencies are defined as follows: 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 (frequency cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Post-marketing surveillance has revealed the following adverse events (all reactions were either localized or general). It is difficult to define a frequency for post-marketing adverse events and therefore events are listed with unknown frequency.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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 national reporting system at: www.agenziafarmaco.gov.it/it/responsabili.

Overdose

Even after oral ingestion of the entire contents of a pack of VECTAVIR cream, no adverse effects should occur; penciclovir is poorly absorbed after oral administration. However, oral irritation may occur. In case of accidental ingestion, no specific treatment is necessary.

Pregnancy

Pregnancy When the cream is used in pregnant women, there is unlikely to be any cause for concern about adverse effects since systemic absorption of penciclovir after topical application of Vectavir cream has been shown to be minimal (see section 5.2). Since the safety of penciclovir in pregnant women has not been established, Vectavir cream should be used, on the advice of a physician, during pregnancy or by mothers who are breastfeeding, only if the potential benefits outweigh the potential risks associated with treatment.

Breastfeeding When the cream is used in breastfeeding women, there is unlikely to be any cause for concern about adverse effects since systemic absorption of penciclovir after topical application of Vectavir cream has been shown to be minimal (see section 5.2). There is no information on the excretion of penciclovir in human milk.