Zoviraxlabiale 5% cream 2g

Zoviraxlabiale 5% cream 2g is a topical treatment specifically formulated to address herpes simplex virus infections of the lips, also known as recurrent herpes labialis . This product is indicated for use in adults and adolescents over 12 years of age. The cream contains Aciclovir , an active ingredient known for its antiviral efficacy, present in a concentration of 50 mg per gram of cream. The formulation is enriched with excipients such as cetostearyl alcohol , sodium lauryl sulphate and propylene glycol , which contribute to its action and stability. Zoviraxlabiale 5% cream 2g is designed to be applied directly to the labial lesions, offering a targeted approach to the treatment of herpes labialis.

ACTIVE INGREDIENTS

Active ingredients contained in Zoviraxlabiale 5% cream 2g - What is the active ingredient of Zoviraxlabiale 5% cream 2g?

One gram of cream contains: Active ingredient: Aciclovir 50 mg. Excipients with known effect: cetostearyl alcohol, sodium lauryl sulphate, propylene glycol. For a full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Zoviraxlabiale 5% cream 2g - What does Zoviraxlabiale 5% cream 2g contain?

Poloxamer 407, Cetostearyl alcohol , Sodium lauryl sulfate , White petrolatum, Liquid paraffin, Arlacel 165, Dimethicone 20, Propylene glycol , Purified water.

DIRECTIONS

Therapeutic indications Zoviraxlabiale 5% cream 2g - Why is Zoviraxlabiale 5% cream 2g used? What is it used for?

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

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Zoviraxlabiale 5% cream 2g - When should Zoviraxlabiale 5% cream 2g not be used?

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

DOSAGE

Quantity and method of taking Zoviraxlabiale 5% cream 2g - How to take Zoviraxlabiale 5% cream 2g?

Topical use. Adults and adolescents over 12 years of age: ZOVIRAXLABIALE 5% cream should be applied 5 times a day at approximately 4-hourly intervals, omitting the nighttime application. ZOVIRAXLABIALE 5% cream should be applied as early as possible, preferably during the earliest stages (prodromes or erythema). However, treatment can also be started in the later stages (papules or vesicles). Treatment should continue for at least 4 days. If healing has not occurred, treatment may continue for up to a maximum of 10 days. If after 10 days the lesions are still present, it is advisable for patients to consult their doctor. Patients should wash their hands before and after applying the cream and avoid unnecessary rubbing of the lesions or touching them with a towel in order to avoid worsening or transmission of the infection. Children under 12 years of age : The safety and efficacy of ZOVIRAXLABIALE have not been studied in patients under 12 years of age. Patients with renal or hepatic impairment : Aciclovir is eliminated primarily by the kidneys, but systemic absorption of aciclovir after topical application is negligible. Consequently, no dose adjustment is required in patients with renal or hepatic impairment (see Pharmacokinetic properties ).

CONSERVATION

Storage Zoviraxlabiale 5% cream 2g - How to store Zoviraxlabiale 5% cream 2g?

Store below 25°C. Do not refrigerate.

WARNINGS

Warnings Zoviraxlabiale 5% cream 2g - About Zoviraxlabiale 5% cream 2g it is important to know that:

ZOVIRAXLABIALE 5% cream should only be used for cold sores present on the mouth. Application to mucous membranes such as those of the mouth, eyes is not recommended and should not be used in the treatment of genital herpes. Particular care should be taken to avoid accidental application in the eyes. It is recommended that people with particularly severe forms of recurrent cold sores consult their doctor. Use of the product, especially if prolonged, may give rise to sensitization phenomena: if this occurs, treatment should be stopped and the doctor should be consulted. It is recommended that those who suffer from cold sores avoid transmission of 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 is not recommended in immunocompromised patients. It is recommended that such patients consult their doctor regarding the treatment of any infection. Important information about some of the ingredients: 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 medicinal product contains cetostearyl alcohol. It may cause localised skin reactions (e.g. contact dermatitis). This medicinal product contains 3.75 mg of sodium lauryl sulphate per dose equivalent to 7.5 mg/g. Sodium lauryl sulphate may cause skin irritation (stinging or burning sensation) or intensify skin reactions caused by other medicinal products when applied to the same area.

INTERACTIONS

Interactions Zoviraxlabiale 5% cream 2g - Which medicines or foods can modify the effect of Zoviraxlabiale 5% cream 2g?

No clinically significant interactions have been identified.

SIDE EFFECTS

Like all medicines, Zoviraxlabiale 5% cream 2g can cause side effects - What are the side effects of Zoviraxlabiale 5% cream 2g?

The undesirable 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 (the frequency cannot be estimated from the available data). Skin and subcutaneous tissue disorders . Uncommon : • transient burning or pain after application of ZOVIRAXLABIALE 5% cream, • moderate dryness or peeling of the skin, • itching; Rare : • erythema, • contact dermatitis following application. Where sensitivity testing has been performed, the substances giving reactivity phenomena have been shown to be the components of the base cream rather than aciclovir. Immune system disorders . Very rare : • immediate hypersensitivity including angioedema and urticaria. 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: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Zoviraxlabiale 5% cream 2g - What are the risks of Zoviraxlabiale 5% cream 2g in case of overdose?

ZOVIRAXLABIALE 5% cream is a preparation for topical use. Even if the entire contents of a 2 g pack of ZOVIRAXLABIALE 5% cream are ingested or applied locally, no undesirable effects should be expected. In case of suspected overdose, the patient should consult a doctor.

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 Zoviraxlabiale 5% cream 2g.

Fertility : There are no data on the effects of oral or intravenous infusion of aciclovir on female fertility. In a study of 20 male patients with normal sperm counts, oral aciclovir at doses up to 1 g/day for up to 6 months has been shown to have no effect on the number, morphology or motility of spermatozoa in men. Pregnancy : The use of ZOVIRAXLABIAL 5% cream should be considered only if the potential benefits outweigh the possibility of unknown risks. However, systemic exposure to aciclovir following topical application of aciclovir cream is very low. A post-marketing pregnancy registry of aciclovir use has provided information on pregnancy outcomes in women exposed to various formulations of aciclovir. These observations have not shown an increase in the number of birth defects among subjects exposed to aciclovir compared with the general population and all birth defects did not show any peculiarity or common features, such as to suggest a single cause. Systemic exposure to aciclovir following topical application of aciclovir cream is very low. Breast-feeding : Although some data indicate that aciclovir passes into breast milk following systemic administration, the dose received by an infant following maternal use of ZOVIRAXLABIALE 5% cream, should be insignificant. During pregnancy and breast-feeding ZOVIRAXLABIALE 5% cream should be used only after consulting the doctor and evaluating with him the risk/benefit ratio in the individual case.

DRIVING AND USE OF MACHINERY

Taking Zoviraxlabiale 5% cream 2g before driving or using machines - Does Zoviraxlabiale 5% cream 2g affect driving or using machines?

ZOVIRAXLABIALE 5% cream is unlikely to affect your ability to drive or use machines.