ZOVIRAXLABIALE 5 % Cream

Зміст інструкції

1. ZOVIRAXLABIALE 5 % CREAM
   1. What is ZOVIRAXLABIALE and what it is used for
   2. What you need to know before using ZOVIRAXLABIALE
2. ZOVIRAXLABIALE for a long period of time, sensitisation (allergic reactions) may occur.
   1. How to use ZOVIRAXLABIALE
   2. Possible side effects
   3. How to store ZOVIRAXLABIALE
   4. Contents of the pack and other information

ZOVIRAXLABIALE 5 % CREAM

aciclovir

Read this leaflet carefully before usingthis medicine because it contains important
information for you

• Use this medicine always as exactly 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 effect occurs, 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 ZOVIRAXLABIALE is and what it is used for
• 2. What you need to know before you use ZOVIRAXLABIALE
• 3. How to use ZOVIRAXLABIALE
• 4. Possible side effects
• 5. How to store ZOVIRAXLABIALE
• 6. Contents of the pack and other information

1. What is ZOVIRAXLABIALE and what it is used for

ZOVIRAXLABIALE contains the active ingredient aciclovir, which is used for the treatment of infections
caused by viruses called herpes viruses, including the herpes simplex virus.
ZOVIRAXLABIALE is used in adults and adolescents over the age of 12 for the treatment
of lip infections (recurrent herpes labialis) caused by the herpes simplex virus.
See your doctor if the lesions on your lips are still present after 10 days.

2. What you need to know before using ZOVIRAXLABIALE

Do not use ZOVIRAXLABIALE

• If you are allergic to aciclovir, valaciclovir or any of the other ingredients of this medicine (listed in section 6).
• In children under the age of 12 years.

Warnings and precautions
Talk to your doctor before using ZOVIRAXLABIALE

• If you are not sure you have cold sores.
• If you have a particularly severe form of cold sores.
• If your immune system is compromised (for example if you have undergone a bone marrow transplant or if you have AIDS). In this case, consult your doctor for the treatment of any infection. Use with caution with ZOVIRAXLABIALE
• ZOVIRAXLABIALE is for external use only and should only be used to treat lesions on the lips caused by herpes simplex. Therefore, do not apply ZOVIRAXLABIALE to the mucous membranes of the mouth, nose, eyes, and do not use it to treat genital herpes.
• Do not unnecessarily rub the lesions and do not touch them with a towel to avoid worsening or transmitting the infection. Always wash your hands before and after applying the cream or after touching

the lesions. Do not touch your eyes in particular after touching the lesions or applying the cream. If the
cream accidentally comes into contact with your eyes, wash them thoroughly with lukewarm water. If you

ZOVIRAXLABIALE for a long period of time, sensitisation (allergic reactions) may occur.

In this case, stop treatment and consult your doctor.

Other medicines and ZOVIRAXLABIALE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
It is unlikely that ZOVIRAXLABIALE will interact significantly with other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
During pregnancy and breastfeeding, ZOVIRAXLABIALE should only be used after consulting your doctor, who will assess the possible risks and benefits for the mother and the baby.

Driving and using machines
No adverse effects on the ability to drive and use machines are known.

ZOVIRAXLABIALE contains cetostearyl alcohol, sodium lauryl sulfate and propylene glycol
This medicine contains 200 mg of propylene glycol per dose equivalent to 400 mg/g.
This medicine contains cetostearyl alcohol. It may cause localised skin reactions (e.g.
contact dermatitis).
This medicine contains 3.75 mg of sodium lauryl sulfate per dose equivalent to 7.5 mg/g. Sodium lauryl sulfate may cause skin irritation (a stinging or burning sensation) or intensify skin reactions caused by other medicines when applied to the same area.

3. How to use ZOVIRAXLABIALE

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.
ZOVIRAXLABIALE is for external use only.
Start treatment as soon as the first symptoms of the infection appear (e.g., itching and/or burning
and/or pain).
If you have not started treatment as soon as you had the first symptoms of the infection, you can also start it when
blisters appear. ZOVIRAXLABIALE can be used both in the early stage of the infection (itching
and/or burning and/or pain), and in the blister stage.
Wash your hands before and after applying the cream and avoid rubbing the lesions unnecessarily or touching them
with a towel to prevent worsening or transmission of the infection.

How much
Caution: do not exceed the recommended dose.

Adults and adolescents over 12 years of age
The recommended dose is to apply 5 times a day at intervals of approximately 4 hours, skipping the night application. Apply the amount of cream necessary to cover the entire infected area, including the outer edges
of any blisters.

Children under 12 years of age
ZOVIRAXLABIALE should not be used in children under 12 years of age (see the paragraph Do

not use ZOVIRAXLABIALE).

For how long
Continue treatment for at least 4 days. If you are not healed after 4 days, you can continue treatment
for a maximum of 10 days.
If the lesions are still present after 10 days, consult your doctor.
Also consult your doctor if the disorder recurs or if you notice any recent change
in its characteristics.

If you use more ZOVIRAXLABIALE than you should
Even if the cream is applied in excessive amounts or is ingested, no adverse effects are expected.
However, if you have used a dose higher than recommended or have accidentally ingested
ZOVIRAXLABIALE, inform your doctor immediately or go to the nearest hospital.

If you forget to use ZOVIRAXLABIALE
If you have forgotten to apply the cream, do not worry. Apply the cream as soon as you remember and then continue
treatment as before. Do not use a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects reported for ZOVIRAXLABIALE are:
Uncommon side effects (may affect up to 1 in 100 people):

• burning or temporary pain after application of ZOVIRAXLABIALE
• moderate dryness or flaking of the skin
• itching.

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

• redness of the skin (erythema)
• skin inflammation following application due to contact with the cream (contact dermatitis). Very rare side effects (may affect up to 1 in 10,000 people):
• immediate allergic reactions (hypersensitivity) including swelling of the lips, face, neck and throat (angioedema) and skin reaction (urticaria).

In case of an allergic reaction with symptoms such as facial swelling, stop using the product and consult a
doctor immediately.
These side effects are generally transient. Following the instructions contained in the package
leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform 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 ZOVIRAXLABIALE

Keep this medicine out of sight and reach of children.
Do not store at a temperature above 25°C. Do not refrigerate.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month. The expiry date refers to the product in
intact packaging, correctly stored.
Do not use this medicine if you notice:

• that the membrane sealing the tube opening is not intact
• that the adhesive seal of the bottle is missing or is not intact.

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 box

6. Contents of the pack and other information

What ZOVIRAXLABIALE contains

• The active ingredient is aciclovir. One gram of cream contains 50 mg of aciclovir.
• The other ingredients are: Poloxamer 407, cetostearyl alcohol, sodium lauryl sulfate, white petrolatum, liquid paraffin, Arlacel 165, dimethicone 20, propylene glycol, purified water.

Description of the appearance of ZOVIRAXLABIALE and contents of the pack
ZOVIRAXLABIALE is a cream contained in an aluminum tube of 2 g or in a
polypropylene bottle with an applicator of 2 g.

Marketing Authorisation Holder
Haleon Italy S.r.l. - Via Monte Rosa 91 - 20149 Milan

Manufacturer
GlaxoSmithKline Consumer Healthcare GmbH & Co. KG - Barthstrasse 4 - 80339 München – Germany