VECTAVIR CREMA 2G 1%

VECTAVIR CREMA 1%

active ingredients

Each gram of cream contains 10 mg of excipient penciclovir with known effects: 77.2 mg of cetosterial alcohol, 416 mg of propylene glycol. For the full list of excipients, see paragraph 6.1.

Excellent

Solid paraffin Liquid paraffin Cetostearilic alcohol propylene glycol Cetomacrogol 1000 Red iron oxide (E-172) Yellow iron oxide (E-172) Purified water

Therapeutic indications

VECTAVIR LABIALE is indicated for the treatment of herpes labialis.

Contraindications

Hypersensitivity to the active ingredient, famciclovir or any of the excipients listed in the paragraph 6.1. Children under the age of 12.

Population

Adults (including seniors) and children over 12 years of age VECTAVIR LABIALE should be applied at intervals of about 2 hours during 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 begin therapy later, VECTAVIR LABIALE has proven to be effective in accelerating the healing of lesions, reducing pain associated with the same and shortening the time of viral diffusion. Pediatric population Children (under 12 years of age) The use of VECTAVIR LABIALE is not recommended in children under 12 years of age due to lack of data on safety and/or effectiveness.

Conservation

Don't freeze. Do not store the packaged medicine in the 2 g aluminum tube at a temperature above 25 °C. Do not store the medicines packaged in the plastic bottle with 2 g dispenser and in the aluminum tube from 5 g to temperature above 30 °C.

Warnings

The cream should only be applied on lip lesions and around the mouth. It is not recommended for application on mucous membranes (e.g. in the eyes, mouth or nose or genitals). Special attention should be paid to avoid application in the eyes or near the eyes. Severely immunocompromised patients (e.g. AIDS patients or bone marrow transplants) should be encouraged to consult a doctor if an oral therapy is indicated. VECTAVIR LABIALE contains cetosterial alcohol: it can cause local skin reactions (e.g. contact dermatitis). VECTAVIR LABIALE contains 416 mg of propylene glycol in each gram of cream: it can cause skin irritation.

Interactions

The experience in clinical trials has not identified interactions resulting from the concomitant administration of drugs for topical or systemic use and VECTAVIR LABIALE cream.

Effects

VECTAVIR LABIALE cream was well tolerated during human studies. The experience from clinical trials has shown that there is no difference in frequency or type of adverse reactions between VECTAVIR LABIALE cream and placebo. The most common events are adverse events in the application area. Adverse reactions are listed below by system of organs, classes and frequencies. The frequencies are defined as follows: Very common (>1/10); common (>1/100 a non-common (>1/1.000 a rare (>1/10.000 a very rare (not known (frequency cannot be defined on the basis of available data). Within each frequency class, unwanted effects are reported in decreasing order of gravity.

General pathologies and disorders at the application site
Town	Reactions to the application site (including skin burning sensation, skin pain, hypoesthesia).

Surveillance after marketing highlighted the following adverse events (all reactions were either localized or general). It is difficult to define a frequency for adverse events after placing on the market and therefore events are listed with unknown frequency

Immune system disorders	Hypersensitivity, hives
Pathologies of skin and subcutaneous tissue	Allergic dermatitis (including rash, itching, bladders and edema)

Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdosing

Even after oral ingestion of the entire content of a packaging VECTAVIR LABIALE cream, no side effects should occur; penciclovir is poorly absorbed after oral administration. However, an irritation of the oral cable can be manifested. In case of accidental ingestion, no specific treatment is required.

Pregnancy When cream is used in pregnant women, it is unlikely that there is some reason for concern for adverse effects as systemic absorption of penciclovir after topical application of VECTAVIR LABIALE cream has been minimal (see Section 5.2). Since the safety of penciclovir has not been established in pregnant women, VECTAVIR LABIALE cream should be used on advice of a doctor during pregnancy or by mothers who are breastfeeding, only if potential benefits are higher than the potential risks associated with treatment. Food When cream is used in women who are breastfeeding, it is unlikely that there is some reason for concern for adverse effects as systemic absorption of penciclovir after topical application of VECTAVIR LABIALE cream has been minimal (see Section 5.2). There is no information on penciclovir excretion in human milk.

Source: Farmadati