MAT CUT 3G 5%

ALOVEXLABICS 5% MATITA CUTANEA

active ingredients

A gram of cutaneous pencil contains 50 mg of aciclovir. Excipient with known effects: A gram of cutaneous pencil contains 0.2 mg of butyl-hydroxytoluene. For the full list of excipients, see paragraph 6.1.

Excellent

Castor oil Semisintetic Glycerides Cera carnauba White paraffin Octildodecanol Butil–hydroxytoluene Aroma vanilla.

Therapeutic indications

AlovexLabiale is indicated in the treatment of herpes simplex virus infections of the lips (recurring herpes labialis) in adults and adolescents (aged over 12 years).

Contraindications

Hypersensitivity to the active ingredient, valaciclovir or any of the excipients listed in the paragraph 6.1. Children under 12 years of age.

Population

Adults and teenagers (aged 12 years) AlovexLabiale must be applied 5 times a day at intervals of about 4 hours, omitting the night application. AlovexLabiale must be applied to injuries or areas where they are developing as early as possible after the infection begins. It is particularly important to begin the treatment of recurring episodes during the prodromi stage or the first appearance of injuries. The treatment must continue for at least 5 days and up to a maximum of 10 if you did not have healing. The medicinal product must be applied directly on the lesions without using contact with the hands; patients should, however, wash their hands after application; it is necessary to avoid unnecessarily rubbing injuries or touching them with a towel in order to avoid worsening or transmission of the infection. The medicinal product must be considered of exclusive personal use; therefore, once opened it must be used by the same patient for the duration of the drug's life and should not be shared with different subjects. Pediatric population The safety and effectiveness of AlovexLabiale in children under the age of 12 have not been established.

Conservation

Store at a temperature below 25° C in the original packaging to protect the medicine from light. Don't refrigerate.

Warnings

AlovexLabiale must be used only for the labial herpes present on the lips. The application on mucous membranes such as mouth or nose, eyes or vagina is not recommended, as it can cause irritation. The medicine should not be used in the treatment of genital herpes. Special attention should be paid to avoid accidental application in the eyes. The long-term use of the product can result in awareness-raising, where this is necessary to stop treatment. There are no signs of drug addiction or addiction. It is recommended that persons with particularly severe forms of recurrent labial herpes consult the doctor. It is recommended that those suffering from labial herpes avoid the transmission of the virus especially when active injuries are present. The safety and effectiveness of AlovexLabiale have not been studied in patients with the altered immune system, so the use of AlovexLabiale is not recommended in severely immunocompromised patients (patients with AIDS or patients with bone marrow transplant). In these patients should be considered the administration of aciclovir in oral formulations. It is also recommended that such patients consult the doctor about the treatment of any infection. Important information about some excipients: Butyl-hydroxytoluene can cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucosa.

Interactions

No clinically significant interactions have been identified. Other types of dermatologic products (such as cosmetics, sunscreen creams, cocoa butter) or medications that treat herpes at the same time as AlovexLabiale.

Effects

The following Convention was used for the classification of unwanted effects in frequency term: very common ≥ 1/10, common ≥ 1/100 and pathologies of skin and subcutaneous tissue Not common • burning or transient pain after application • moderate dryness or skin dequamation • itching sensation Rare • erythema • contact dermatitis after application. Where sensitivity tests were conducted, it was shown that substances that gave reactivity phenomena were the components of the basic skin pencil rather than aciclovir. Immune system disorders Very rare • reactions from immediate hypersensitivity that include 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 the address www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

Even in case the entire content of a cutaneous pencil container is ingested, no side effects should be expected.

Pregnancy

You should consider using aciclovir only if potential benefits exceed the possibility of unknown risks. However, systemic exposure to aciclovir as a result of topical application 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 administration of aciclovir in standard tests accepted internationally has not produced any embryotoxic or teratogenic effects in rabbits, rats or mice. In a non-standard rat test, fetal abnormalities were observed but only after subcutaneous doses so high that maternal toxicity was caused. The clinical relevance of these results is uncertain.

Food

Limited human data indicates that the medicinal product is excreted in breast milk after systemic administration. However, the dose received by a milker following the use of AlovexLabiale by the mother should be insignificant.

Fertility

See preclinical studies in the paragraph 5.3.

Source: Farmadati