Vectavir 1% cream 2g

INDICATIONS

Vectavir is indicated for the treatment of herpes labialis.

ACTIVE INGREDIENTS

Each gram of cream contains 10 mg of penciclovir. Excipients with known effects: 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.

CONTRAINDICATIONS AND SIDE EFFECTS

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

DOSAGE

Adults (including the elderly) and children over 12 years of age: VECTAVIR should be applied at intervals of approximately 2 hours throughout the day. Treatment, to be continued 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 proven effective in accelerating the healing of lesions, reducing the pain associated with them and shortening the time for viral spread. Application instructions: VECTAVIR must be applied, in an amount suitable for the size of the area to be treated, with a clean finger or with a disposable applicator which must be discarded after use [for packages containing applicators]. Pediatric 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.

CONSERVATION

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: it may cause local skin reactions (e.g. contact dermatitis). Vectavir contains 416 mg of propylene glycol in each gram of cream: may cause skin irritation.

INTERACTIONS

Experience in clinical trials has not identified interactions resulting from the concomitant administration of drugs for topical or systemic use and Vectavir cream.

SIDE EFFECTS

Vectavir cream was well tolerated during studies in humans. 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 adverse events in the application area. Adverse reactions are listed below by system organ class, class and frequency. The 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 class, undesirable effects are presented in order of decreasing seriousness.

Systemic pathologies and conditions relating to the administration site.

Common: Application site reactions (including skin burning sensation, skin pain, hypoesthesia).

Post-marketing surveillance highlighted 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 an unknown frequency.

Immune system disorders: Hypersensitivity, urticaria.

Skin and subcutaneous tissue disorders: Allergic dermatitis (including rash, pruritus, blisters and edema).

Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetti-reazione-avversa.

OVERDOSE

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

PREGNANCY AND BREASTFEEDING

Pregnancy: When the cream is used in pregnant women, there is unlikely to be any cause for concern about adverse effects as systemic absorption of penciclovir following topical application of Vectavir cream was found to be minimal (see section 5.2). As the safety of penciclovir in pregnant women has not been established, Vectavir cream should be used, on the advice of a doctor, 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 women who are breastfeeding, there is unlikely to be any cause for concern about adverse effects as systemic absorption of penciclovir following topical application of Vectavir cream has been found to be minimal (see section 5.2). There is no information on the excretion of penciclovir in human milk.

EFFECTS ON DRIVING ABILITY

Vectavir does not affect the ability to drive or use machines.