Alovex Labiale

Patient Information Leaflet

AlovexLabiale 50 mg/g Skin Pencil

aciclovir
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, please ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, please contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement 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 AlovexLabiale is and what it is used for

AlovexLabiale contains the active substance aciclovir.
It belongs to a group of medicines called "antivirals" which fight infections caused by viruses. AlovexLabiale is specifically active against herpes viruses, including the Herpes simplex virus.
AlovexLabiale is used to treat recurrent Herpes simplex virus infections of the lips (recurrent Herpes labialis) in adults and adolescents (over 12 years of age).
If you do not feel better or feel worse after 10 days, consult your doctor.

2. What you should know before using AlovexLabiale

Do not use AlovexLabiale

• if you are allergic to aciclovir or to 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
Talk to your doctor or pharmacist before using AlovexLabiale.
AlovexLabiale should only be applied to \textit{Herpes simplex} lesions on the lips; application inside the mouth, 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 into the eyes.
Prolonged use of the product, especially, may lead to allergic reactions. If this occurs, discontinue treatment and consult your doctor.
If you suffer from particularly severe or frequently recurring forms of cold sores, consult your doctor.
If you have cold sores, avoid transmitting the virus, especially when small blisters are present (active lesions) (see section on Health education notes).
Do not use AlovexLabiale if you have a condition in which your body's immune system does not function properly (such as AIDS or bone marrow transplantation). In such cases, consult your doctor for treatment of cold sores and any other infections.

Health education notes
Cold sores are contagious; therefore, do not allow other people to touch the lesions or use personal items that could transmit the infection (e.g. towels).
After applying the medicine, do not touch other parts of your body, especially the eyes, with your fingers before washing your hands. Always wash your hands before and after touching the lesions.
Avoid touching your eyes. Herpes infection of the eyes may lead to damage of the outer part of the eye (corneal ulcers).
Avoid kissing—especially children—when you have lesions.
Avoid breaking the small blisters or 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
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No significant interactions with other medicines are known.
Do not apply other types of skin products (such as cosmetics, sunscreen creams, lip balm) or other medicines for treating herpes while using AlovexLabiale.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant and/or breastfeeding, use AlovexLabiale only after consulting your doctor and evaluating with him the risk/benefit ratio in your specific case.

Driving and using machines
AlovexLabiale does not affect the ability to drive or operate machinery.

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

3. How to use AlovexLabiale

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults and adolescents aged over 12 years
Dosage
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 the medicine directly from the container onto the affected area.
Caution: do not exceed the recommended doses.
When and for how long
Apply the medicine every 4 hours during the day for at least 5 consecutive days. If healing has not occurred, treatment may be continued for an additional 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 symptoms of herpes (tingling, redness, swelling, or itching).
Consult your doctor if the condition recurs frequently or if you notice any recent changes in its characteristics.
Consult your doctor if symptoms persist after 10 days of treatment or if they worsen at any time.
How to apply
Apply AlovexLabiale directly to the lesions without using your hands; wash your hands after application; try to avoid unnecessarily rubbing the lesions or touching them with a towel, in order to prevent worsening or spreading of the infection.
AlovexLabiale is intended for personal use only; once opened, use it for the entire shelf life of the medicine 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 the medicine is accidentally ingested, no adverse effects are expected, as it is poorly absorbed.
In case of accidental ingestion/overdose of AlovexLabiale, contact your doctor immediately or go to the nearest hospital.
If you forget to use AlovexLabiale
If you forget to apply the medicine, do so as soon as possible, then continue using it as directed.
Do not use a double dose to make up for the missed dose.
If you stop using AlovexLabiale
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody experiences them.
Uncommon (may affect up to 1 in 100 people)

• transient burning or pain after application
• mild dryness or peeling of the skin
• itching sensation

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

• skin irritation and redness (erythema)
• inflammation of the skin (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 urticaria.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 below 25°C in the original packaging to protect the medicine from light. Do not refrigerate.
After first opening the container, the medicine should 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 stated on the carton after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
It is important to always have medicine information available; therefore, keep both the carton and the package leaflet.

6. Package contents and other information

What AlovexLabiale contains

• The active substance is aciclovir. One gram of cutaneous pencil contains 50 mg of aciclovir.
• The other components are castor oil, semisynthetic glycerides, carnauba wax, white paraffin, beeswax, octyldodecanol, butyl-hydroxytoluene, vanilla flavour.

Description of the appearance of AlovexLabiale and contents of the pack
AlovexLabiale is available as a cutaneous pencil (stick) consisting of a cylindrical container/applicator which dispenses the medicine by rotating the base.
The pack contains 1 applicator with 3 g of cutaneous pencil (stick).
Marketing Authorization Holder
RECORDATI Industria Chimica e Farmaceutica S.p.A. – Via Matteo Civitali, 1 – 20148 Milan, Italy.
Manufacturer
Laboratorio Chimico Farmaceutico A. Sella srl – Via Vicenza, 67 – 36015 Schio (VI), Italy.