ALOVEXLABIALE VEXLABIALE 5% Skin pencil

Зміст інструкції

1. AlovexLabiale 50 mg/g cutaneous pencil
   1. What is AlovexLabiale and what is it used for?
   2. What you need to know before using AlovexLabiale
   3. How to use AlovexLabiale
   4. Possible side effects
   5. How to store AlovexLabiale
   6. Contents of the pack and other information

AlovexLabiale 50 mg/g cutaneous pencil

aciclovir

Read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 10 days.

Contents of this leaflet:

• 1. What AlovexLabiale is and what it is used for
• 2. What you need to know before using AlovexLabiale
• 3. How to use AlovexLabiale
• 4. Possible side effects
• 5. How to store AlovexLabiale
• 6. Contents of the pack and other information

1. What is AlovexLabiale and what is it used for?

AlovexLabiale contains the active ingredient aciclovir.
It belongs to a group of medicines called “antivirals” that fight infections caused by
viruses. AlovexLabiale is specifically active against herpes viruses, including the virus

Herpes simplex.
AlovexLabiale is used to treat recurrent Herpes simplexvirus infections of the lips that occur repeatedly over
time (Herpes labialisrecurrent) in adults and adolescents (over 12 years of age).
See your doctor if you do not feel better or if you feel worse after 10 days.

2. What you need to know before using AlovexLabiale

Do not use AlovexLabiale

• if you are allergic to aciclovir or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to another medicine containing valaciclovir;
• if you are a child under 12 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using AlovexLabiale.
AlovexLabiale should only be applied to Herpes simplexlesions on the lips; application inside the mouth, in the eyes, nose or vagina (mucous
membranes) is not recommended as it may cause irritation.
Do not use AlovexLabiale to treat genital herpes.
Take particular care to avoid accidental application to the eyes.
Use, especially if prolonged, of the product may lead to allergic reactions. If this happens
stop treatment and consult your doctor.
If you suffer from particularly severe forms of lip herpes that recur over time, consult your
doctor.
If you suffer from lip herpes, avoid transmitting the virus, especially when
the small blisters (active lesions) are present (see section Health education notes).
Do not use AlovexLabiale if you have a condition in which the body's defense systems do not function
properly (AIDS or bone marrow transplant). In these cases, consult your doctor for treatment
of lip herpes and any other infection.

Health education notes
Lip herpes is contagious, so do not allow other people to touch the lesions or
use personal items that could transmit the infection (e.g. the towel).
After applying the medicine, do not touch other parts of your body with your fingers, especially your eyes,
before washing your hands. Always wash your hands before and after touching the lesions.
Avoid touching your eyes. Herpes eye infection can lead to lesions on the outermost part of the eyes (corneal ulcers).
Avoid kissing – especially children – when you have lesions.
Avoid breaking the small blisters and scratching the scabs. Not only could the lesions become infected
with other germs, but you could also infect your fingers with the virus.
Avoid sharing glasses, cutlery, etc. with other people.

Children
AlovexLabiale is contraindicated in children under 12 years of age.

Other medicines and AlovexLabiale
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No significant interactions with other medicines are known.
Do not apply other types of skin products (such as cosmetics, sunscreens, cocoa butter)
or medicines that treat herpes while using AlovexLabiale.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant and/or breastfeeding, use AlovexLabiale only after consulting your doctor and
assessing the risk/benefit ratio in your case with him.

Driving and using machines
AlovexLabiale does not impair the ability to drive vehicles and use machines.

AlovexLabiale contains butyl-hydroxytoluene
It may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and the
inside of the mouth, nose and genitals (mucous membranes).

3. How to use AlovexLabiale

Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults and adolescents over 12 years of age
How much
The recommended dose is 5 applications per day, at intervals of approximately 4 hours throughout the day.
Do not apply at night.
Apply a small amount of medicine directly from the container to the affected area.
Caution: do not exceed the indicated doses.

When and for how long
Apply the medicine every 4 hours during the day for at least 5 consecutive days. If healing does not occur, treatment may be continued for another 5 days (up to a maximum of 10
days).
The maximum effectiveness of AlovexLabiale is achieved when used promptly, at the first sign of a herpes lesion. For optimal results, apply the medicine at the first signs of herpes (tingling, redness, swelling or itching).
Consult your doctor if the condition recurs or if you notice any recent change in its characteristics.
Consult your doctor if symptoms persist after 10 days of treatment or if they worsen at any time.

How
Apply AlovexLabiale directly to the lesions without using hand contact; wash your hands after application; try to avoid rubbing the lesions unnecessarily or touching them with a
towel in order to avoid worsening or transmission of the infection.

AlovexLabiale should be considered for personal use only; therefore, once opened, use it for the entire duration of the medicine's shelf life and do not share it with other people.
Use in children
AlovexLabiale is contraindicated in children under 12 years of age.

If you use more AlovexLabiale than you should
If you accidentally ingest the medicine, no adverse effects should occur, as it is
poorly absorbed.
In case of accidental ingestion/intake of an excessive dose of AlovexLabiale, immediately inform your doctor or go to the nearest hospital.

If you forget to use AlovexLabiale
If you forget to use the medicine, apply it as soon as possible, then continue to use it
normally.
Do not use a double dose to make up for a missed dose.

If you stop treatment with AlovexLabiale
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Uncommon (may affect up to 1 in 100 people)

• transient burning or pain after application
• moderate skin dryness or flaking
• sensation of itching

Rare (may affect up to 1 in 1,000 people)

• skin irritation and redness (erythema)
• skin inflammation (contact dermatitis) after application

Very rare (may affect up to 1 in 10,000 people)

• immediate allergic reactions including swelling of the face, lips, tongue and other parts of the body (angioedema) and hives.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse .
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store AlovexLabiale

Store at a temperature below 25°C in the original packaging to protect the medicine
from light. Do not refrigerate.
After the first opening of the container, the medicine must be used within 3 months; after
this period, any remaining medicine must be discarded.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.
It is important to always have the information about the medicine available, therefore keep both the

6. Contents of the pack and other information

What AlovexLabiale contains

• The active ingredient is aciclovir. One gram of cutaneous pencil contains 50 mg of aciclovir.
• The other ingredients are castor oil, semi-synthetic glycerides, carnauba wax, white paraffin, beeswax, octyldodecanol, butylhydroxytoluene, vanilla flavour.

Description of the appearance of AlovexLabiale and contents of the pack
AlovexLabiale is presented in the form of a cutaneous pencil (stick) consisting of a cylindrical container/applicator
that dispenses the medicine by rotating the base.
The pack contains 1 applicator of 3 g of cutaneous pencil (stick).

Marketing Authorisation Holder
RECORDATI Industria Chimica e Farmaceutica S.p.A. – Via Matteo Civitali, 1 – 20148 Milano.

Manufacturer
Laboratorio Chimico Farmaceutico A. Sella srl – Via Vicenza, 67 – 36015 Schio (VI).