Alovex labiale cutaneous pencil minsan 042187017

ALOVEXLABIALE * MAT CUT 3G 5%

Therapeutic indications

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

Dosage and method of use

Adults and adolescents (over 12 years of age)AlovexLabiale must be applied 5 times a day at intervals of approximately 4 hours, omitting the nocturnal application. AlovexLabiale should be applied to lesions or areas where they are developing as early as possible after the infection begins. It is especially important to start treatment for recurrent episodes during the prodrome phase or at the first appearance of lesions. Treatment should continue for at least 5 days and up to a maximum of 10 if there is no healing. The medicine should be applied directly to the lesions without using hand contact; however, patients should wash their hands after application; it is necessary to avoid unnecessarily rubbing the lesions or touching them with a towel in order to avoid worsening or transmission of the infection.The medicine should be considered for personal use only; therefore, once opened, it must be used by the same patient for the entire life span of the medicine and must not be shared with different subjects. Pediatric populationThe safety and efficacy of AlovexLabiale in children aged less than 12 years have not been established.

Contraindications

Hypersensitivity to the active substance, to valaciclovir or to any of the excipients listed in section 6.1. Children under the age of 12.

Side effects

The following convention has been used for the classification of undesirable effects in terms of frequency: very common ≥ 1/10, common ≥ 1/100 and Skin and subcutaneous tissue disordersUncommon• transient burning or pain after application • moderate dryness or peeling of the skin • itching sensationRare• erythema • contact dermatitis after application. Where sensitivity tests were conducted, it was shown that the reactive substances were the components of the basic skin pencil rather than acyclovir.Disorders of the immune system Very rare• immediate hypersensitivity reactions including angioedema and urticaria.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Special warnings

AlovexLabiale should only be used for cold sores present on the lips. Application to mucous membranes such as those of the 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. Particular care should be taken to avoid accidental application into the eye. The use of the product especially if prolonged can give rise to sensitization phenomena, where this happens it is necessary to stop the treatment. There are no reports of addiction or dependence on the drug. It is recommended that people with particularly severe forms of recurrent cold sores consult their doctor. It is recommended that those suffering from cold sores avoid transmission of the virus especially when active lesions are present. The safety and efficacy of AlovexLabiale have not been studied in patients with impaired immune systems, therefore the use of AlovexLabiale is not recommended in severely immunocompromised patients (AIDS patients or bone marrow transplant patients). Administration of aciclovir in oral formulations should be considered in these patients. It is also recommended that such patients consult their physician regarding the treatment of any infections.Important information about some of the ingredients: Butyl – hydroxytoluene can cause local skin reactions (eg contact dermatitis) or irritation of the eyes and mucous membranes.

Pregnancy and breastfeeding

PregnancyThe use of aciclovir should only be considered if the potential benefits outweigh the possibility of unknown risks. However, the systemic exposure to aciclovir following topical application is very low. A post-marketing registry of aciclovir use in pregnancy provided data on pregnancy outcomes in women exposed to the various aciclovir formulations. These observations did not show an increase in the number of birth defects among acyclovir-exposed subjects compared to the general population, and all birth defects found did not show any common features or characteristics that would suggest a single cause. Systemic administration of aciclovir in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rabbits, rats or mice. In a non-standard test in rats, fetal abnormalities were observed but only following subcutaneous doses so high as to induce maternal toxicity. The clinical relevance of these findings is uncertain.Feeding timeLimited data in humans indicate that the medicinal product is excreted in breast milk following systemic administration. However, the dose received by an infant following the use of AlovexLabiale by the mother should be insignificant.FertilitySee preclinical studies in section 5.3.

Expiration and retention

Store below 25 ° C in the original package to protect from light. Do not refrigerate.

Interactions with other drugs

No clinically significant interactions have been identified. You should not apply other types of dermatological products (such as cosmetics, sunscreen creams, cocoa butter) or drugs that treat herpes at the same time as AlovexLabiale.

Overdose

Even if the entire contents of a skin pencil container are ingested, no unwanted effects should be expected.

Active principles

One gram of skin pencil contains 50 mg of acyclovir. Excipient with known effect: One gram of skin pencil contains 0.2 mg of butyl – hydroxytoluene. For the full list of excipients, see section 6.1.

Excipients

Castor oil Semisynthetic glycerides Carnauba wax White paraffin Beeswax Octildodecanol Butyl – hydroxytoluene Vanilla flavor.