Zovirax Duo

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Zovirax Duo, (50 mg + 10 mg)/g, cream

Aciclovir + Hydrocortisone

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as advised by
your doctor, pharmacist, or nurse.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should speak to a pharmacist.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. See section 4.
• If symptoms persist for 5 days after completing treatment, you should contact your doctor.

Table of contents of the leaflet

• 1. What is Zovirax Duo and what is it used for
• 2. Important information before using Zovirax Duo
• 3. How to use Zovirax Duo
• 4. Possible side effects
• 5. How to store Zovirax Duo
• 6. 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 works
against viruses and helps to combat the virus that causes cold sores. Hydrocortisone is a mild
steroid that reduces the inflammation associated with cold sores.
Zovirax Duo cream is used to treat the early symptoms of cold sores and skin around the mouth (such as tingling, itching, or redness), to reduce the risk of developing cold sores into blisters in adults and adolescents from 12 years of age.
Even if the cold sore has already developed into blisters, using Zovirax Duo reduces the healing time of the sores by about half a day to one day, compared to a cream that does not contain active substances.
Cold sores are caused by the herpes simplex virus. This virus causes the formation of blisters and ulcers, mainly on the lips, but also on other parts of the face. Cold sores can develop when the body's immune system is weakened, for example during a cold or other infection. Stress, strong sunlight, low temperatures, or menstruation can also trigger cold sores.
If symptoms persist for 5 days after completing treatment, you should contact your doctor.

2. Important information before using Zovirax Duo

When not to use Zovirax Duo

• if you are allergic to aciclovir, valaciclovir, hydrocortisone, or any of the other ingredients of this medicine (listed in section 6),
• in case of skin infections not caused by the virus that causes cold sores.

Warnings and precautions

You should use Zovirax Duo only on cold sores and skin around the mouth.
You should talk to your doctor if you have severe, recurrent cold sores to check if you have any other health problems.
You should not use Zovirax Duo:

• in the eyes, inside the mouth, in the nose, or on the genitals,
• to treat genital herpes,
• if you have a weakened immune system, for example, if you have had a bone marrow transplant or are infected with HIV or have diagnosed immune system disorders,
• together with dressings, such as wound dressings or cold sore patches.

You should wash your hands before and after applying the cream to avoid worsening the symptoms
of the disease or transferring it to other people.
If you experience blurred vision or other vision disturbances, you should contact your doctor.
You should not use the medicine for more than 5 days.

Children

You should not use this medicine in children under 12 years of age, as the efficacy and safety of its use in this age group are not known.

Zovirax Duo and other medicines

You should tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
It is not known whether the action of Zovirax Duo may change if you are taking other medicines at the same time.

Zovirax Duo with food and drink

You should not apply this medicine just before eating, as it may be licked off in this situation.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before using this medicine.
You should not use Zovirax Duo during pregnancy and breastfeeding unless your doctor considers that the benefit to the mother outweighs the unknown risk.

Driving and using machines

Zovirax Duo does not affect the ability to drive and use machines.

Zovirax Duo contains propylene glycol and cetearyl alcohol

This medicine contains 200 mg of propylene glycol in each gram of cream.
Cetearyl alcohol may cause local skin reactions (such as contact dermatitis).

Zovirax Duo contains sodium lauryl sulfate

The medicine contains 8 mg of sodium lauryl sulfate in each gram of cream.
Sodium lauryl sulfate may cause local skin reactions (such as stinging or burning) or may exacerbate 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 you are unsure, you should speak to your doctor or pharmacist.
Zovirax Duo is for external use only.
You should not use a larger dose than recommended.

Use in adults and children over 12 years of age

Apply the cream 5 times a day for 5 days (on average every 3-4 hours during the day). It is recommended to start treatment as soon as possible, preferably after the first symptoms of cold sores appear (such as tingling, redness, or itching).
You should not use the medicine for more than 5 days.
If the symptoms of cold sores persist for more than 5 days after completing treatment, you should contact your doctor.

Use

You should wash your hands before and after applying the cream to avoid worsening the cold sore or infecting another person.
If an ulcer develops, you should not touch the area more often than necessary to avoid transferring the infection to other parts of the body or to the eyes.

Using a larger dose of Zovirax Duo than recommended

If you accidentally apply too much cream or swallow it, it is unlikely to cause any health problems. However, if you swallow a large amount of cream, you should contact your doctor.
If you have any doubts about using this medicine, you should speak to your doctor or pharmacist.

Missing a dose of Zovirax Duo

If you miss a dose, you should apply the medicine as soon as you remember, and then continue treatment as before.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should stop using the medicine and contact your doctor immediately if you experience any of the following symptoms of an allergic reaction (very rare side effects: may occur less than 1 in 10,000 patients):

• swelling of the face, tongue, or throat, which may cause difficulty swallowing or breathing;
• hives.

The following side effects are listed in order of their likelihood:

Common: may affect up to 1 in 10 people

• Dryness and flaking of the skin.

Uncommon: may affect up to 1 in 100 people

• Temporary burning, tingling, or stinging, which may occur immediately after applying the cream.
• Itching.

Rare: may affect up to 1 in 1,000 people

• Inflammation symptoms, such as lip swelling.
• Redness.
• Discoloration of the skin.

Unknown:

• Blurred vision.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zovirax Duo

You should keep the medicine out of the sight and reach of children.
Store in a temperature 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 month.
Shelf life after first opening the tube: 3 months.
Do not use this medicine if it has changed appearance and/or consistency.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Zovirax Duo contains

• The active substances are aciclovir and hydrocortisone. One gram of cream contains 50 mg of aciclovir and 10 mg of hydrocortisone.
• The other ingredients are: liquid paraffin, white petrolatum, isopropyl myristate, sodium lauryl sulfate, cetearyl 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 white to yellowish cream.
The packaging of the medicine is an aluminum tube coated with epoxy-phenolic lacquer from the inside, with an HDPE cap or an aluminum tube laminated with HDPE, with an HDPE cap, containing 2 g of cream, placed in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

GlaxoSmithKline Consumer Healthcare S.R.L.
Str. Costache Negri, Nr.1-5, Opera Center One
Etaj 6 (Zona 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., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Authorization number in Romania, the country of export:14344/2022/01
14344/2022/02

Parallel import authorization number: 297/24

This medicine is authorized in the Member States of the European Economic Area 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

Date of leaflet approval: 23.07.2024

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