MAT CUT 3G 5%

EFRIVIRALLABIALE 5% MATITA CUTANEA

active ingredients

A gram contains: Active ingredient Aciclovir 50 mg. Excipients: butil–hydroxytoluene. For the full list of excipients, see paragraph 6.1.

Excellent

Castor oil, semisynthetic glycerides, carnauba wax, white paraffin, beeswax, octildodecanol, vanilla aroma, butil–hydroxytoluene.

Therapeutic indications

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

Contraindications

Patients with hypersensitivity to Aciclovir, valaciclovir, or any of the excipients. Children under 12 years of age.

Population

Adults and teenagers (aged 12 years) EFRIVIRALLABIALE must be applied 5 times a day at intervals of about 4 hours, omitting the night application. EFRIVIRALLABIALE must be applied on 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. Children under 12 years The safety and effectiveness of EFRIVIRALLABIALE have not been studied in patients under the age of 12.

Conservation

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

Warnings

EFRIVIRALLABIALE must be used only for the labial herpes present on the lips. It is not advisable to apply the mucous membranes of the mouth or nose. 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 hepres avoid the transmission of the virus especially when active injuries are present. The safety and effectiveness of EFRIVIRALLABIALE have not been studied in patients with the altered immune system, therefore the use of EFRIVIRALLABIALE 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 should also be recommended that such patients consult the doctor regarding the treatment of any infection. Important information about some EFRIVIRALLABIALE excipients: Butylhydroxytoluene contained in the medicinal product may cause allergic reactions (also delayed). It can cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucosa.

Interactions

Other types of dermatologic products (such as cosmetics, sunscreen creams, cocoa butter) or medications that treat herpes at the same time as EFRIVIRALLABIALE.

Effects

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

Overdosing

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

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. The use of EFRIVIRALLABIALE should be considered only if potential benefits exceed the possibility of unknown risks. Limited data indicate that the drug is found in breast milk following systemic administration. However, the dose received by a milker following the use of EFRIVIRALLABIALE in the mother should be insignificant.

Source: Farmadati