Vectavir labial 1% 2 g cream

Vectavir labiale 1 % 2 g cream is a specific topical treatment for the treatment of herpes labialis , ideal for those who want a rapid and targeted action against the typical symptoms of the viral infection of the lips. Its formulation contains 1% penciclovir , an antiviral active ingredient that acts directly on the labial lesions caused by the herpes simplex virus, helping to block viral replication and promote faster healing of vesicles and ulcers. Thanks to its cream texture, Vectavir labial is easy to apply and quickly absorbed, offering a local treatment that reduces the pain, burning and itching associated with herpes. The 2g package is practical and discreet, perfect to always carry with you and intervene promptly at the first symptoms. Vectavir labiale 1% is particularly indicated for those who suffer from recurrent herpes and are looking for an effective solution to limit the spread of the infection and shorten the duration of symptoms. The presence of excipients such as cetostearyl alcohol and propylene glycol guarantees good skin tolerability and uniform distribution of the active ingredient on the affected area. Choosing Vectavir labiale 1% 2g cream means relying on an antiviral with proven efficacy for the rapid and localized treatment of labial herpes , reducing aesthetic and functional discomfort and promoting the return to well-being of the lips.

ACTIVE INGREDIENTS

Active ingredients contained in Vectavir labiale 1 % 2 g cream - What is the active ingredient of Vectavir labiale 1 % 2 g cream?

Each gram of cream contains 10 mg of penciclovir Excipients with known effect: 77.2 mg of cetostearyl alcohol, 416 mg of propylene glycol. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Vectavir labial 1 % 2 g cream - What does Vectavir labial 1 % 2 g cream contain?

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

DIRECTIONS

Therapeutic indications Vectavir labiale 1 % 2 g cream - Why is Vectavir labiale 1 % 2 g cream used? What is it used for?

VECTAVIR LABIALE is indicated for the treatment of herpes labialis.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Vectavir labiale 1 % 2 g cream - When should Vectavir labiale 1 % 2 g cream not be used?

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

DOSAGE

Quantity and method of taking Vectavir labial 1% 2 g cream - How is Vectavir labial 1% 2 g cream taken?

Adults (including the elderly) and children over 12 years of age VECTAVIR LABIALE should be applied at intervals of approximately 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 start therapy later, VECTAVIR LABIALE has been shown to be effective in accelerating the healing of lesions, reducing the pain associated with them and shortening the time of viral shedding. Paediatric population Children (under 12 years of age) The use of VECTAVIR LABIALE is not recommended in children under 12 years of age due to the lack of data on safety and/or efficacy.

CONSERVATION

Storage Vectavir labial 1 % 2 g cream - How is Vectavir labial 1 % 2 g cream stored?

Do not freeze. Do not store the medicine packaged in the 2 g aluminium tube above 25 °C. Do not store the medicine packaged in the 2 g plastic bottle with dispenser and the 5 g aluminium tube above 30 °C.

WARNINGS

Warnings Vectavir labiale 1 % 2 g cream - About Vectavir labiale 1 % 2 g cream it is important to know that:

The cream should only be applied to lesions 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. Severely immunocompromised patients (e.g. patients with AIDS or who have undergone a bone marrow transplant) should be encouraged to consult a physician if oral therapy is indicated. VECTAVIR LABIALE contains cetostearyl alcohol: may cause local skin reactions (e.g. contact dermatitis). VECTAVIR LABIALE contains 416 mg of propylene glycol in each gram of cream: may cause skin irritation.

INTERACTIONS

Interactions Vectavir labiale 1 % 2 g cream - Which medicines or foods can modify the effect of Vectavir labiale 1 % 2 g cream?

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

SIDE EFFECTS

Like all medicines, Vectavir labiale 1 % 2 g cream can cause side effects - What are the side effects of Vectavir labiale 1 % 2 g cream?

VECTAVIR LABIALE 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 LABIALE cream and placebo. The most common events are application site adverse events. 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 (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

General pathologies and disorders at the application site
Common	Application site reactions (including skin burning sensation, skin pain, hypoesthesia).

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 an unknown frequency.

Immune system disorders	Hypersensitivity, urticaria
Skin and subcutaneous tissue disorders	Allergic dermatitis (including rash, itching, blistering and swelling)

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur 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: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

OVERDOSE

Overdose Vectavir labiale 1 % 2 g cream - What are the risks of Vectavir labiale 1 % 2 g cream in case of overdose?

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

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Vectavir labiale 1% 2g cream.

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 LABIALE cream has been shown to be minimal (see Section 5.2). Since the safety of penciclovir in pregnant women has not been established, VECTAVIR LABIALE cream should be used on the advice of a physician during pregnancy or by mothers who are breast-feeding, only if the potential benefits outweigh the potential risks associated with treatment. Breast-feeding When the cream is used in women who are breast-feeding, there is unlikely to be any cause for concern about adverse effects since systemic absorption of penciclovir after topical application of VECTAVIR LABIALE cream has been shown to be minimal (see Section 5.2). There is no information on the excretion of penciclovir in human milk.

DRIVING AND USE OF MACHINERY

Taking Vectavir labiale 1 % 2 g cream before driving or using machines - Does Vectavir labiale 1 % 2 g cream affect driving or using machines?

Vectavir Labial does not alter the ability to drive vehicles or use machines.