Zovirax Duo

Package Leaflet: Information for the User

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

Aciclovir + Hydrocortisone

Read the package leaflet carefully before using the medicine, as it contains

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

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If symptoms persist for 5 days after the end of treatment, the patient should contact their 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 acts
against viruses and helps fight 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 signs 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 aged 12 and over.
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 ingredients.
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, e.g., 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 the end of treatment, the patient should consult their 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 the case of skin infections not caused by the virus that causes cold sores.

Warnings and precautions

Zovirax Duo should only be used on cold sores and skin around the mouth.
The patient should talk to their doctor if they have severe, recurring cold sores to check if they have any other health problems.
Zovirax Duo should not be used:

• in the eyes, inside the mouth, in the nose, or on the genitals,
• to treat genital herpes,
• if the patient has a weakened immune system, e.g., after a bone marrow transplant or if they are infected with HIV or have diagnosed immune system disorders,
• with dressings, such as wound dressings or cold sore patches.

Hands should be washed before and after applying the cream to avoid worsening the symptoms
of the disease or transferring it to others.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
Zovirax Duo should not be used for more than 5 days.

Children

This medicine should not be used in children under 12 years of age, as its efficacy and safety in this age group are not known.

Zovirax Duo and other medicines

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

Zovirax Duo with food and drink

The cream should not be applied immediately before eating, as it may be licked off in this situation.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Zovirax Duo should not be used during pregnancy and breastfeeding unless the 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.
Cetearyl alcohol may cause local skin reactions (e.g., contact dermatitis).

Zovirax Duo contains sodium lauryl sulfate

The medicine contains 8 mg of sodium lauryl sulfate.
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 package leaflet for the patient or as advised by
the doctor, pharmacist, or nurse.
In case of doubt, the patient should consult their doctor or pharmacist.
Zovirax Duo is for external use only.
A higher dose than recommended should not be used.

Use in adults and children over 12 years of age

The cream should be applied 5 times a day for 5 days (on average every 3-4 hours during the day). Treatment should be started as soon as possible, preferably after the first signs of a cold sore (such as tingling, redness, or itching).
The cream should not be used for more than 5 days.
The patient should consult their doctor if the symptoms of the cold sore persist for more than 5 days after the end of treatment.

Use

Hands should be washed before and after applying the cream to avoid worsening the cold sore or infecting another person.
If an ulcer develops, the area should not be touched more often than necessary to avoid transferring the infection to other parts of the body or to the eyes.

Using a higher dose of Zovirax Duo than recommended

If the patient accidentally uses too much cream or swallows it, it is unlikely to cause any health problems. However, if a large amount of cream is swallowed, the patient should consult their doctor.
In case of doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

Missing a dose of Zovirax Duo

If a dose is missed, the patient should apply the cream as soon as they 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.
The patient should stop using the medicine and consult their doctor immediately if they experience any of the following symptoms of an allergic reaction (very rare side effects: may occur less frequently than in 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 occur in up to 1 in 10 people

• Dryness and flaking of the skin.

Uncommon: may occur in up to 1 in 100 people

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

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

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

Unknown:

• blurred vision

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Zovirax Duo

The medicine should be stored out of sight and reach of children.
Store at 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 carton and tube after “EXP” or “Expiry Date”. 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 its appearance and/or consistency have changed.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Zovirax Duo contains

• The active substances of the medicine 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 pack contains an aluminum tube or an aluminum tube laminated with HDPE, containing 2 g of cream, placed in a cardboard box.

Marketing authorization holder:

Haleon Poland Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. 800 702 849

Importer:

Haleon Germany GmbH
Barthstraße 4
80339 Munich
Germany
Haleon Denmark ApS
Delta Park 37, 2665, Vallensbæk Strand
Denmark
Haleon Belgium NV,
Da Vincilaan 5,
1930 Zaventem,
Belgium
Haleon - Gebro Consumer Healthcare GmbH
Bahnhofbichi 13, 6391 Fieberbrunn
Austria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Names in other languages:

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

Date of last revision of the leaflet: August 2024

Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.