VECTAVIR * CREAM 2G 1%

VECTAVIR * CREAM 2G 1%

Therapeutic indications

Vectavir is indicated for the treatment of herpes labialis.

Dosage and method of use

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 been shown to be effective in accelerating wound healing, reducing pain associated with wounds and shortening the time to viral spread.Application instructions: VECTAVIR must be applied, in a quantity 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 below 12 years of age due to a lack of data on safety and / or efficacy.

Contraindications

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

Side 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 adverse events in the application area. Adverse reactions are listed below by organ system, class and frequency. The frequencies are defined as follows:very common(> 1/10);common(> 1/100 a uncommon (> 1 / 1,000 a rare (> 1 / 10,000 a very rare (not known (cannot be estimated from the available data). Within each frequency class, the undesirable effects are reported in descending order of severity.

Post-marketing surveillance 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 the events are listed with an unknown frequency.

. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio 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-sospetta-reazione-avversa.

Special warnings

The cream should only be applied to the lesions of the lips and around the mouth. Application on 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 (eg patients with AIDS or who have undergone a bone marrow transplant) should be encouraged to consult a physician if oral therapy is indicated. Vectavir contains cetostearyl alcohol: may cause local skin reactions (e.g. contact dermatitis). Vectavir contains 416 mg of propylene glycol in each gram of cream: it can cause skin irritation.

Pregnancy and breastfeeding

Pregnancy: When the cream is used in pregnant women, there is unlikely to be any cause for concern for 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 physician, during pregnancy or by mothers who are breastfeeding, only if the potential benefits outweigh the potential risks associated with treatment.Feeding time:When the cream is used in women who are breastfeeding, there is unlikely to be any cause for concern for 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.

Expiry and retention

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

Interactions with other drugs

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

Overdose

Even after oral ingestion of the entire contents of a pack of VECTAVIR cream, no undesirable 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.

Active principles

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.