Zoviraxlabiale 5% cream 2g

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

ZOVIRAXLABIALE 5% cream is indicated in the treatment of herpes simplex virus infections of the lips (herpes labialis recurrent) in adults and adolescents (over 12 years of age).

CONTRAINDICATIONS

Hypersensitivity to the active substance, to valaciclovir, or to any of the excipients. Children under 12 years old.

WARNINGS AND PRECAUTIONS FOR USE

ZOVIRAXLABIALE 5% cream should only be used for cold sores present on the mouth. Application to mucous membranes such as those of the mouth and eyes is not recommended and should not be used in the treatment of genital herpes. Particular care should be taken to avoid accidental application into the eyes. It is recommended that people with particularly severe forms of recurrent cold sores consult their doctor. The use of the product, especially if prolonged, can give rise to sensitization phenomena: if this happens, treatment should be stopped and the doctor should be consulted. It is recommended that those who suffer from cold sores avoid transmitting the virus, especially when active lesions are present (for example by washing their hands before and after applying the cream, see Dosage and method of administration). The use of ZOVIRAXLABIALE 5% cream in immunocompromised patients is not recommended. It is recommended that such patients consult their doctor regarding the treatment of any infection. Important information about some excipients: ZOVIRAXLABIALE 5% cream contains propylene glycol, cetostearyl alcohol, sodium lauryl sulphate. This medicinal product contains 200 mg of propylene glycol per dose equivalent to 400 mg/g. This medicine contains cetostearyl alcohol. May cause localized skin reactions (e.g. contact dermatitis). This medicinal product contains 3.75 mg sodium lauryl sulphate per dose equivalent to 7.5 mg/g. Sodium lauryl sulfate may cause skin irritation (stinging or burning sensation) or intensify skin reactions caused by other medicines when applied to the same area.

INTERACTIONS

No clinically significant interactions have been identified.

SIDE EFFECTS

The side effects reported for ZOVIRAXLABIALE 5% cream are listed according to the following convention on the frequency of occurrence: very common: ≥ 1/10, common: ≥ 1/100 and < 1/10, uncommon: ≥ 1/1000 and < 1/100, rare: ≥ 1/10000 and < 1/1000, very rare: <1/10000, not known (frequency cannot be estimated from the available data). Pathologies of the skin and subcutaneous tissue. Uncommon: • transient burning or pain after application of ZOVIRAXLABIALE 5% cream, • moderate dryness or flaking of the skin, • itching; Rare: • erythema, • contact dermatitis following application. Where sensitivity tests were conducted, it was shown that the substances causing reactivity phenomena were the components of the base cream rather than acyclovir.Immune system disorders. Very rare: • immediate hypersensitivity including angioedema and urticaria. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.