ACICLINLABIALE * 2G CREAM 5%
ACICLINLABIALE is indicated for the treatment of herpes simplex lip virus infections (recurrent herpes Iabialis) in adults and adolescents (over 12 years of age).
Dosage and method of use
Dosage Adults and adolescents (over 12 years of age) ACICLINLABIALE must be applied 5 times a day at intervals of about 4 hours, omitting the night application. ACICLINLABIALE should be applied to lesions or areas where they are developing as early as possible after the onset of infection. It is especially important to start treatment for recurrent episodes during the prodrome phase or when lesions first appear. Treatment should continue for at least 5 days and up to a maximum of 10 if there is no healing. Patients should wash their hands before and after applying the cream and avoid unnecessarily rubbing the lesions or touching them with a towel in order to avoid worsening or transmission of the infection. Pediatric population The safety and efficacy of ACICLINLABIALE in children aged less than 12 years have not yet been established.
ACICLINLABIALE is contraindicated in patients with hypersensitivity to the active substance, valacilovir, propylene glycol or to any of the excipients listed in section 6.1. Children under the age of 12.
The following convention has been used for the classification of undesirable effects in terms of frequency: very common > 1/10, common ≥ 1/100 and> 1 / 1,000 and Skin and subcutaneous tissue disorders Uncommon • transient burning or pain after applying ACICLINLABIALE • moderate dryness or peeling of the skin • itching Rare • erythema • contact dermatitis after application. Where susceptibility tests were conducted, it was shown that the reactive substances were the components of the base cream rather than acyclovir. Disorders of the immune system Very rare • immediate hypersensitivity reactions including angioedema and urticaria Reporting of suspected adverse reactions Reporting 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 http://www.agenziafarmaco.gov.it/it/responsabili.
ACICLINLABIALE should only be used for cold sores present on the lips. The product is not for ophthalmic use, nor is it recommended to apply to the mucous membranes of the mouth or nose, eye or vagina, as it can cause irritation. The product 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. No addiction or dependence on the drug has been reported. It is recommended that people with particularly severe forms of recurrent cold sores consult their doctor. It is recommended that those with cold sores avoid transmission of the virus especially when active lesions are present. The safety and efficacy of ACICLINLABIALE have not been studied in patients with impaired immune systems, therefore the use of ACICLINLABIALE is not recommended in severely immunocompromised patients (patients with AIDS or patients with bone marrow transplant). In these patients, administration of aciclovir in oral formulations should be considered. It should also be recommended that such patients consult their physician regarding the treatment of any infections. Important information about some of the excipients of ACYCLINLABIAL: The methyl – para – hydroxy – benzoate contained in the medicine can cause allergic reactions (even delayed). The excipient propylene glycol can cause skin irritation.
Pregnancy and breastfeeding
Pregnancy A registry of post-marketing use of aciclovir in pregnancy provided data on pregnancy outcomes in women exposed to the various formulations of aciclovir. 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 particularities or common characteristics that would suggest a single cause. The use of ACICLINLABIALE should only be considered if the potential benefits outweigh the possibility of unknown risks. However, the systemic exposure of aciclovir following topical application of aciclovir cream is very low. 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 rat test, fetal abnormalities were observed after subcutaneous doses of aciclovir so high that they produced toxic effects on the mother. The clinical relevance of these findings is uncertain. Feeding time Limited data in humans indicate that the drug is found in breast milk after systemic administration. However, the dose received by an infant following the use of ACICLINLABIALE in the mother should be insignificant. Fertility Reversible toxic effects on spermatogenesis have been reported in rats and dogs only at systemic dosages significantly higher than therapeutic ones. Two-generation studies in mice revealed no effects of aciclovir, administered orally, on fertility. There are no data on the effects of aciclovir cream on female fertility. Aciclovir cream has not been shown to affect sperm count, morphology and motility in humans.
Expiration and retention
Do not store above 25 ° C. Do not refrigerate. For storage conditions after first opening see section 6.3.
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 ACICLINLABIALE.
Even if the entire contents of a tube containing 100 mg of aciclovir are ingested, no undesirable effects should be expected.
One gram of cream contains 50 mg of Aciclovir. Excipient with known effects: methyl – para – hydroxy – benzoate. For the full list of excipients, see section 6.1
Tefose 1500, Glycerin, Stearic acid, Liquid paraffin, Methyl – para – hydroxybenzoate, Purified water