Vectavir Labial Cream 2 grams 1%

WARNINGS
The cream should only be applied to the lesions of the lips and around the mouth. It is not recommended for application on mucous membranes (eg 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 (eg patients with AIDS or who have undergone a bone marrow transplant) should be encouraged to consult a physician if oral therapy is indicated. The medicine contains cetostearyl alcohol: it can cause local skin reactions (for example contact dermatitis). The drug contains propylene glycol: it can cause skin irritation.
PHARMACOTHERAPEUTIC CATEGORY
Topical chemotherapy.
STORAGE
Do not freeze; do not store above 30 degrees C.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance, famciclovir or to any of the listed excipients; children under the age of 12.
NAME
VECTAVIR LABIAL 1% CREAM
EXCIPIENTS
Solid paraffin; liquid paraffin; cetostearyl alcohol; propylene glycol; cetomacrogol 1000; red iron oxide (E-172); yellow diiron oxide (E-172); purified water.
SIDE EFFECTS
The drug 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 the drug 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 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. General pathologies and application site disorders. Common: Application site reactions (including skin burning sensation, skin pain, hypoesthesia). >> Post-marketing experience (frequency unknown). Immune system disorders: hypersensitivity, urticaria. Skin and subcutaneous tissue disorders. Allergic dermatitis (including rash, itching, blistering and edema). The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.
PREGNANCY AND BREASTFEEDING
When the cream is used in pregnant women, it is unlikely that there is any cause for concern for adverse effects as systemic absorption of penciclovir after topical application of the cream drug was found to be minimal. Since the safety of penciclovir in pregnant women has not been established, the medicinal 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. When the cream is used in women who are breastfeeding, it is unlikely that there is any cause for concern about adverse effects as systemic absorption of penciclovir after topical application of the cream product has been found to be minimal. There is no information on the excretion of penciclovir in human milk.
INDICATIONS
Treatment of herpes labialis.
INTERACTIONS
Experience in clinical trials has not identified interactions resulting from the concomitant administration of topical or systemic drugs and the cream drug.
DOSAGE
Adults (including the elderly) and children over 12 years of age ': the medicine should be applied at intervals of about 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, the drug has been shown to be effective in accelerating wound healing, reducing associated pain and shortening the viral spread time. Children (under 12 years of age): the use of the product is not recommended in children under 12 years of age due to a lack of data on safety and / or efficacy.
ACTIVE PRINCIPLES
Penciclovir.