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  • Aesculapius Pharmaceuticals Efrivirallabiale 5% Skin Pencil 3g -18%

Aesculapius Pharmaceuticals Efrivirallabiale 5% Skin Pencil 3g

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Aesculapius Pharmaceuticals

Efrivirallabiale 5%

Skin pencil

 

Composition

One gram contains: Active ingredient Aciclovir 50 mg Excipients: butyl hydroxytoluene For a full list of excipients, see section 6.1

 

Excipients

Castor oil, semisynthetic glycerides, carnauba wax, white paraffin, beeswax, octildodecanol, vanilla flavoring, butyl hydroxytoluene.

 

Therapeutic indications

Efrivirallabiale is used to treat herpes simplex virus infections of the lips (recurrent herpes labialis) in adults and children over 12 years.

 

Contraindications

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

 

dosage

Adults and adolescents (older than 12 years) EFRIVIRALLABIALE must be applied 5 times a day at intervals of about 4 hours, omitting the night application. EFRIVIRALLABIALE must be applied to the lesions or areas where they are developing, as early as possible after the start of the infection. It is particularly important to begin the treatment of recurrent episodes during the prodromal phase or at the first appearance of the lesions. Treatment should continue for at least 5 days and up to a maximum of 10 if no recovery has taken place. The medicine should be applied directly to the lesions without using hand contact; patients must, however, wash their hands after application; it is necessary to avoid unnecessarily rubbing the lesions or touching them with a towel in order to avoid the worsening or transmission of the infection. The medicine must 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. Children under the age of 12 The safety and efficacy of EFRIVIRALLABIALE have not been studied in patients under the age of 12 years.

 

Warnings and precautions

EFRIVIRALLABIALE must be used only for the cold sores present on the lips. It is not advisable to apply it on the mucous membranes of the mouth or nose.The medicine should not be used in the treatment of genital herpes. Special care must be taken to avoid accidental application in the eyes. The use, especially if prolonged, of the product can give rise to sensitization phenomena, where this occurs it is necessary to interrupt the treatment. No phenomena of addiction or dependence on the drug are reported. It is recommended that people with particularly severe forms of recurrent cold sores consult their doctor. It is recommended that those who suffer from labial hepres avoid the transmission of the virus especially when active lesions are present. The safety and efficacy of EFRIVIRALLABIALE have not been studied in patients with altered immune systems, therefore the use of EFRIVIRALLABIALE is not recommended in severely immunocompromised patients (patients with AIDS or patients with bone marrow transplantation). In these patients the administration of aciclovir in oral formulations should be considered. Furthermore, it should be recommended that such patients consult their physician regarding the treatment of any infection. Important information about some of the ingredients of EFRIVIRALLABIALE: The butylated hydroxytoluene in the medicine can cause allergic reactions (even delayed). May cause local skin reactions (eg contact dermatitis) or irritation of the eyes and mucous membranes.

 

Interactions

You should not apply other types of dermatological products (such as cosmetics, sun protection creams, cocoa butter) or drugs that treat herpes simultaneously with EFRIVIRALLABIALE.

 

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 <1/10, uncommon ≥ 1/1000 and <1/100, rare ≥ 1 /10,000 and <1/1000, very rare <1 / 10,000. Skin and subcutaneous tissue disordersNot common burning or transient pain after the application of EFRIVIRALLABIALE moderate dryness and peeling of the skin itching Raroeritema contact dermatitis after application. Where sensitivity tests were conducted, it was shown that the substances that gave reactivity phenomena were the components of the basic cutaneous pencil rather than the acyclovir. Immune system disorders Very rare immediate hypersensitivity reactions including angioedema

 

Pregnancy and breastfeeding

A record concerning the use of acyclovir in pregnancy after commercialization has provided data on pregnancy outcomes in women exposed to various formulations of acyclovir. These observations did not show an increase in the number of birth defects among subjects exposed to acyclovir compared to the general population and all the defects found at birth showed no particularity or common characteristics, such as to suggest a single cause. The use of EFRIVIRALLABIALE should be considered only if the potential benefits outweigh the possibility of unknown risks. Limited data indicate that the drug is found in breast milk following systemic administration. However, the dose received by an infant following the use of EFRIVIRALLABIALE in the mother should be insignificant.

 

Format

Skin pencil - 3 g applicator

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