Herpes cream treatment.
Indications
Vectavir Labial is used for the treatment of cold sores at a 1% concentration.
Composition
Active ingredients
Each gram of cream contains 10 mg of penciclovir. Excipients with known effects: 77.2 mg of cetostearyl alcohol, 416 mg of propylene glycol.
Excipients
Solid paraffin Liquid paraffin Cetostearyl alcohol Propylene glycol Cetomacrogol 1000 Red iron oxide (E-172) Yellow iron oxide (E-172) Purified water.
Directions for use and Dosage
Adults (including the elderly) and children over 12 years of age: VECTAVIR LABIALE should be applied at intervals of approximately 2 hours 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 LABIALE has been shown to be effective in accelerating healing of lesions, reducing 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.
Warnings
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., the eyes, mouth, or nose, or the genitals). 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 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.
Contraindications
Hypersensitivity to the active substance, to famciclovir, or to any of the excipients listed in section 6.1. Children under 12 years of age.
Undesirable effects
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. 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.
General disorders and application site conditions (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 establish a frequency for adverse events after marketing authorisation and therefore the events are listed with an unknown frequency.
Immune system disorders: Skin and subcutaneous tissue disorders.
Hypersensitivity, urticaria: Allergic dermatitis (including rash, pruritus, blisters and oedema).
Reporting of suspected adverse reactionsReporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product.
Overdose
Even after oral ingestion of the entire contents of a pack of VECTAVIR LABIALE cream, no adverse 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 since the 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 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 since the 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.
Format
2 g tube
Product Code:FRCM196998
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