Aciclin labiale - cream for the treatment of herpes labialis 2g

Product Description

Fidia

For Cold Sores

Indicated in 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) ACICLINLABIALE must be applied 5 times a day at intervals of approximately 4 hours, omitting the nighttime application. ACICLINLABIALE must be applied to the lesions or areas where they are developing as early as possible after the onset of the infection. It is particularly important to start treatment of recurrent episodes during the prodrome phase or at the first appearance of the lesions. Treatment must continue for at least 5 days and up to a maximum of 10 if healing has not occurred. 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 ACICLINLABIALE have not been studied in patients under 12 years of age.

Contraindications
Contraindicated in patients with known hypersensitivity to aciclovir and valacilovir, propylene glycol or to any of the excipients. Children under 12 years of age.

Warnings
Aciclin Labial must be used only for cold sores on the lips. The product is not for ophthalmic use, nor for oral use. Application to the mucous membranes of the mouth, nose, eyes, or vagina is recommended, as it may cause irritation. The product should not be used to treat genital herpes. Particular care must be taken to avoid accidental application to the eyes. Use, especially if prolonged, may cause sensitization. If this occurs, treatment should be discontinued. No signs of habituation or dependence on the drug have been reported. People with particularly severe forms of recurrent cold sores should consult their doctor. Those suffering from cold sores should avoid transmitting the virus, especially when active lesions are present. The safety and efficacy of ACICLINLABIALE have not been studied in patients with compromised immune systems; therefore, its use is not recommended in severely immunocompromised patients (AIDS patients or bone marrow transplant patients). In these patients, the administration of oral aciclovir formulations should be considered. Furthermore, it should be recommended that such patients consult their doctor regarding the treatment of any infection. Important information about some of the excipientsof ACICLINLABIALE: The methyl-para-hydroxy-benzoate contained in the medicinal product can cause allergic reactions (possibly delayed). The excipient propylene glycol can cause skin irritation.

Pregnancy and breastfeeding

• Pregnancy

A post-marketing registry of aciclovir use in pregnancy has provided data 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 to the general population, and any birth defects found did not show any peculiarities or common features that would suggest a single cause. The use of ACICLINLABIALE 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. 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 after subcutaneous doses of aciclovir high enough to produce toxic effects on the mother. The clinical relevance of these findings is uncertain.

• Breastfeeding

Limited data in humans indicate that the drug is found in breast milk after systemic administration. However, the dose received by an infant following maternal use of the drug is expected to be insignificant. In rats and dogs, reversible toxic effects on spermatogenesis have been reported only at systemic doses considerably higher than therapeutic doses.

• Fertility

Two-generation studies in mice have shown no effects of aciclovir, administered orally, on fertility. No data are available on the effects of aciclovir cream on female fertility. Aciclovir cream has not been shown to have any effect on the number, morphology, or motility of sperm in humans.

Expiry and storage
Check the expiry date indicated on the package. The expiry date indicated on the package refers to the product in its intact packaging, stored correctly. Store below 25°C, do not refrigerate.

Warning: Do not use the medicine after the expiry date shown on the package.

Composition
Aciclinlabiale Pencil contains:
Active ingredient: Aciclovir 50 mg
Excipients: Tefose 1500, Glycerin, Stearic acid, Liquid paraffin, Methyl parahydroxybenzoate, Purified water.

Format
2g tube.