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EFRIVIRALLABIAL * MAT CUT 3G 5%

  • Aesculapius Farmaceutici S.r.l.
  • 038942025

Efrivirallabiale is a drug based on the active ingredient aciclovir (DC.IT) (FU), belonging to the category of Antivirals and specifically Antivirals. Efrivirallabiale can be prescribed with OTC Recipe - self-medication. EFRIVIRALLABIAL 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).

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EFRIVIRALLABIAL * MAT CUT 3G 5%

Therapeutic indications

EFRIVIRALLABIAL 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)EFRIVIRALLABIALE must be applied 5 times a day at intervals of about 4 hours, omitting the night application. EFRIVIRALLABIAL 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 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. Children under the age of 12The safety and efficacy of EFRIVIRALLABIAL have not been studied in patients less than 12 years of age.

Contraindications

Patients with hypersensitivity to Aciclovir, valaciclovir, or to any of the excipients. 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 applying EFRIVIRALLABIAL • moderate dryness and peeling of the skin • itchingRare• 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

Special warnings

EFRIVIRALLABIALE should only be used for cold sores present on the lips. It is not recommended to apply it to the mucous membranes of the mouth or nose.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 labial hepres avoid transmission of the virus particularly when active lesions are present. The safety and efficacy of EFRIVIRALLABIALE have not been studied in patients with impaired immune systems, therefore the use of EFRIVIRALLABIALE 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. Furthermore, it should be recommended that such patients consult their physician regarding the treatment of any infections.Important information about some of the ingredients of EFRIVIRALLABIAL: The butylhydroxytoluene contained in the medicine can cause allergic reactions (including delayed). It can cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

Pregnancy and breastfeeding

A registry of post-marketing use of aciclovir 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. The use of EFRIVIRALLABIAL should only be considered 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 EFRIVIRALLABIAL in the mother should be insignificant.

Expiration and retention

Store at a temperature not exceeding 25 ° C in the original package to protect the medicine from light. Do not refrigerate.

Interactions with other drugs

Other types of dermatological products (such as cosmetics, sunscreen creams, cocoa butter) or drugs that treat herpes should not be applied at the same time as EFRIVIRALLABIAL.

Overdose

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

Active principles

One gram contains:Active principleAciclovir 50 mg. Excipients: butyl – hydroxytoluene. For the full list of excipients, see section 6.1.

Excipients

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

038942025

Data sheet

Packaging
50 mg / g skin pencil applicator of 3 g
Product Type
HUMAN DRUG
ATC code
D06BB03
ATC description
Acyclovir
Therapeutic Group
Antivirals
Active principle
aciclovir (DC.IT) (FU)
Class
C.
Pharmaceutical form
skin pencil / pencil
Type of Administration
topical
Container
tube
Quantity
1 tube
Capacity
3 grams
Quantity of the Active Ingredient
50MG
Recipe required
OTC - self-medication medicine
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