CREMA 2G 5%

ZOVIRAXLABICS 5% CREMA

active ingredients

A gram of cream contains: Active ingredient: Aciclovir 50 mg. Excipients with known effects: cetostearilic alcohol, sulphate lauril sodium, propylene glycol. For the full list of excipients see paragraph 6.1.

Excellent

Polossamero 407, Cetosteari alcohol, Sodium laurilsolfa, White Vaseline, Liquid Paraffin, Arlacel 165, Dimeticone 20, Propylene glycol, Water purified.

Therapeutic indications

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

Contraindications

Hypersensitivity to the active ingredient, valaciclovir, or to any of the excipients. Children under 12 years of age.

Population

Topical use. Adults and teenagers over the age of 12: ZOVIRAXLABIALE 5% cream must be applied 5 times a day at intervals of about 4 hours omitting the night application. ZOVIRAXLABIALE 5% cream must be applied as early as possible, preferably during the precocious phases (prodromes or erythema). However, the treatment can also be started in subsequent stages (papules or vesicles). The treatment must continue for at least 4 days. If you did not have healing, the treatment can continue up to a maximum of 10 days. If after 10 days the injuries are still present, it is recommended that patients consult the doctor. Patients must wash their hands before and after the application of the cream and avoid unnecessarily rubbing the lesions or touching them with a towel in order to avoid worsening or transmitting the infection. Children under 12 years: The safety and effectiveness of ZOVIRAXLABIALE have not been studied in patients under the age of 12. Patients with kidney or liver failure: Aciclovir is eliminated mainly by renal, but the systemic absorption of aciclovir after topical application is negligible. As a result, no dose change is required in patients with kidney or liver failure (see Pharmactical properties).

Conservation

Store at a temperature not exceeding 25°C. Don't refrigerate.

Warnings

ZOVIRAXLABIALE 5% cream must be used only for the labial herpes present on the mouth. The application on mucous membranes such as mouth, eyes and should not be used in the treatment of genital herpes is not recommended. Special attention should be paid to avoid accidental application in the eyes. It is recommended that persons with particularly severe forms of recurrent labial herpes consult the doctor. The long-term use of the product can lead to awareness: if this happens, stop the treatment and consult the doctor. It is recommended that those suffering from labial herpes avoid the transmission of the virus especially when active injuries are present (for example washing their hands before and after the application of the cream, see Posology and method of administration). The use of ZOVIRAXLABIALE 5% cream in immunocompromised patients is not recommended. It is recommended that such patients consult the doctor regarding the treatment of any infection. Important information about some excipients: ZOVIRAXLABIALE 5% cream contains glycol propylene, cetostearilic alcohol, lauril sulphate sodium. This medicine contains 200 mg of glycol propylene per dose equivalent to 400 mg/g. This medicine contains cetosterial alcohol. It can cause reactions to localized skin (e.g. contact dermatitis). This medicine contains 3.75 mg sodium lauril sulphate per dose equivalent to 7.5 mg/g. Sodium lauril sulphate can cause skin irritation (sting or burning sensation) or intensify reactions on the skin caused by other medicines when applied on the same area.

Interactions

No clinically significant interactions have been identified.

Effects

The undesirable effects reported for ZOVIRAXLABIALE 5% cream, are listed according to the following convention on the frequency of appearance: very common: ≥ 1/10, common: ≥ 1/100 and pathologies of skin and subcutaneous tissue. Not common: • burning or transient pain after application of ZOVIRAXLABIALE 5% cream, • moderate dryness or skin dequamation, • itching; Rare: • erythema, • contact dermatitis following application. Where sensitivity tests were conducted, it was shown that substances that gave reactivity phenomena were the components of the base cream rather than aciclovir.Immune system disorders. Very rare: • immediate hypersensitivity that includes angioedema and hives. 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: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

ZOVIRAXLABIALE 5% cream is a topical preparation. Even if the entire content of a 2 g cream pack of ZOVIRAXLABIALE 5% cream is ingested or applied locally, you should not expect unwanted effects. In case of suspect overdose, the patient should consult the doctor.

Fertility: Data relating to the effects of aciclovir in oral formulation or i.v. for infusion on fertility in the woman. In a study of 20 male patients with normal sperm count, oral aciclovir administered at doses of up to 1 gram per day up to 6 months has not shown to have effect on the number, morphology and sperm motility in man. Pregnancy: You should consider using ZOVIRAXLABIALE 5% cream only if potential benefits exceed the possibility of unknown risks. However, systemic exposure to aciclovir following the topical application of aciclovir cream is very low. A register relating to the use of pregnant aciclovir after marketing, provided data on pregnancy outcomes in women exposed to various aciclovir formulations. Such observations did not show an increase in the number of birth defects among individuals exposed to aciclovir in comparison to the general population and all defects found at birth showed no common peculiarities or characteristics, such as to suggest a unique cause. Systemic exposure to aciclovir following the topical application of aciclovir cream is very low. Food: Although some data indicate that aciclovir passes into breast milk as a result of systemic administration, the dose that takes a lactating as a result of the use in the mother of ZOVIRAXLABIALE 5% cream, should be insignificant. In pregnancy and lactation ZOVIRAXLABIALE 5% cream must be used only after consulting the doctor and having evaluated with him the risk/benefit ratio in the individual case.

Source: Farmadati