Patient Information Leaflet

Keep this leaflet! The packaging label is in a foreign language.
Zovirax Duo, (50 mg + 10 mg)/g, cream
Aciclovirum + Hydrocortisonum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse.

Keep this leaflet for future reference.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse effects, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If symptoms persist for 5 days after completion of treatment, consult your doctor.

Table of Contents

What is Zovirax Duo and what is it used for?
Important information before using Zovirax Duo
How to use Zovirax Duo
Possible side effects
How to store Zovirax Duo
Contents of the pack and other information

1. What is Zovirax Duo and what is it used for?

Zovirax Duo contains two active substances: aciclovir and hydrocortisone. Aciclovir has antiviral activity and helps combat the virus that causes cold sores. Hydrocortisone is a mild steroid that reduces inflammation associated with cold sores.
Zovirax Duo cream is used to treat early subjective and objective signs of cold sores on the lips and skin around the mouth (such as tingling, itching, or redness), in order to reduce the risk of progression to blister formation in adults and adolescents aged 12 years and older.
Even if the cold sore has already developed into blisters, treatment with Zovirax Duo cream shortens the healing time by approximately half to one day, compared to a cream without active ingredients.
Cold sores are caused by the herpes simplex virus (Herpes simplex). This virus causes blisters and ulcers, primarily on the lips, but also on other parts of the face. Cold sores may develop when the body's immune system is weakened, for example during a cold or other infection. Stress, strong sunlight, low temperatures, or menstruation may also trigger cold sores.
If symptoms persist for 5 days after treatment ends, consult your doctor.

2. Important information before using Zovirax Duo

When not to use Zovirax Duo

if the patient is allergic to aciclovir, valaciclovir, hydrocortisone, or any of the other ingredients of this medicine (listed in section 6),
in skin infections not caused by the herpes simplex virus.

Warnings and precautions
Zovirax Duo should only be used for cold sores on the lips and skin around the mouth.
Talk to your doctor if you have severe or recurrent cold sores to check whether you may have other underlying health problems.
Do not use Zovirax Duo:

in the eyes, inside the mouth, in the nose, or on genital areas,
for the treatment of genital herpes,
if the patient has a weakened immune system, for example after bone marrow transplantation, if infected with HIV, or if the patient has diagnosed immunological disorders,
together with dressings such as adhesive bandages or cold sore patches.

Wash hands before and after applying the medicine to avoid worsening symptoms or spreading the infection to others.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.
Do not use the medicine for longer than 5 days.
Children
Do not use this medicine in children under 12 years of age, as the efficacy and safety of use in this age group have not been established.
Zovirax Duo and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, including over-the-counter medicines.
It is not known whether the effect of Zovirax Duo may change if the patient is using other medicines at the same time.
Zovirax Duo with food and drink
Do not apply this medicine immediately before eating, as it may be licked off.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Zovirax Duo should not be used during pregnancy or breastfeeding unless the doctor decides that the benefit to the mother outweighs the unknown risk.
Driving and operating machinery
Zovirax Duo has no influence on the ability to drive or operate machinery.
Zovirax Duo contains propylene glycol and cetostearyl alcohol
This medicine contains 200 mg of propylene glycol in each gram of cream.
Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Zovirax Duo contains sodium lauryl sulphate
The medicine contains 8 mg of sodium lauryl sulphate in each gram of cream.
Sodium lauryl sulphate may cause local skin reactions (such as stinging or burning) or may worsen skin reactions caused by other products applied to the same area.

3. How to use Zovirax Duo

This medicine should always be used exactly as described in the patient leaflet or as advised by your doctor, pharmacist, or nurse.
If in doubt, consult your doctor or pharmacist.
Zovirax Duo is intended for external use only.
Do not use more than the recommended dose.

Use in adults and children over 12 years of age
Apply the medicine 5 times daily for 5 days (approximately every 3–4 hours during the day). Treatment should be started as early as possible, preferably at the first signs of cold sore (such as tingling, redness, or itching).
Do not use the medicine for longer than 5 days.
Patients should consult a doctor if cold sore symptoms persist for more than 5 days after completing treatment.

Instructions for use
Hands should be washed before and after applying the cream to avoid worsening the cold sore or spreading infection to others.
If an ulcer develops, avoid touching the area more than necessary to prevent spreading the infection to other parts of the body or to the eyes.

Use of more than the recommended dose of Zovirax Duo
If the patient accidentally applies too much cream or swallows it, it is unlikely to cause any health problems. However, if a large amount of the cream is swallowed, medical advice should be sought.

If in doubt about how to use this medicine, consult your doctor or pharmacist.

Missed dose of Zovirax Duo
If a dose is missed, apply the cream as soon as remembered, then continue treatment as before.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Treatment must be stopped immediately and a doctor should be consulted if any of the following
symptoms of an allergic reaction occur (very rare adverse reactions: may occur in fewer than 1 in 10,000 patients):

Swelling of the face, tongue or throat, which may cause difficulty in swallowing or breathing;
Urticaria.

The adverse reactions listed below are categorized according to their frequency of occurrence:
Common: may occur in up to 1 in 10 people

Dryness and peeling of the skin.

Uncommon: may occur in up to 1 in 100 people

Transient burning, tingling or pricking sensation, which may occur immediately after application of the cream.
Itching.

Rare: may occur in up to 1 in 1,000 patients

Inflammatory symptoms, such as swelling of the lips.
Erythema.
Skin pigmentation disorders.

Not known:

Blurred vision.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Zovirax Duo

Keep this medicine out of sight and reach of children.
Store below 25°C. Do not store in the refrigerator or freeze.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Shelf life after first opening the tube: 3 months.
Do not use this medicine if its appearance and/or consistency has changed.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Zovirax Duo contains

The active substances are acyclovir and hydrocortisone. One gram of cream contains 50 mg of acyclovir and 10 mg of hydrocortisone.
Other ingredients: liquid paraffin, white vaseline, isopropyl myristate, sodium lauryl sulfate, cetostearyl alcohol, poloxamer 188, propylene glycol, citric acid monohydrate, sodium hydroxide, hydrochloric acid, purified water.

What Zovirax Duo looks like and contents of the pack
Zovirax Duo is a cream ranging in color from white to yellow.
The medicine is packed in an aluminum tube internally coated with an epoxy-phenolic lacquer, with a cap made of HDPE, or in a laminated aluminum tube with HDPE, with an HDPE cap, containing 2 g of cream, placed in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, the country of export:
GlaxoSmithKline Consumer Healthcare S.R.L.
Str. Costache Negri, Nr.1-5, Opera Center One
Floor 6 (Zone 2), Sector 5, Bucharest, Romania
Manufacturer:
GlaxoSmithKline Consumer Healthcare GmbH & Co. KG
Barthstrasse 4, 80339 Munich, Germany
GlaxoSmithKline Consumer Healthcare ApS
Delta Park 37, 2665 Vallensbæk Strand, Denmark
GlaxoSmithKline Consumer Healthcare S.A.
Avenue Pascal 2-4-6, 1300 Wavre, Belgium
GSK-Gebro Consumer Healthcare GmbH
Bahnhofbichl 13, 6391 Fieberbrunn, Austria
Parallel importer:
InPharm Sp. z o.o., Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k., Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing authorisation number in Romania, the country of export: 14344/2022/01
14344/2022/02
Parallel import authorisation number: 297/24
This medicinal product is authorised for sale in the European Economic Area Member States under the following names:
Zovirax Duo: Belgium, Bulgaria, Croatia, Czech Republic, Estonia, Netherlands, Ireland, Luxembourg, Latvia, Germany, Poland, Portugal, Romania, Slovakia, Hungary
Zoviduo: Cyprus, Denmark, Finland, Greece, Spain, Iceland, Lithuania, Malta, Norway, Slovenia, Sweden, Italy
Activir Duo: Austria
Xerclear: France