ZOVIDUO 50 mg/g + 10 mg/g CREAM

Introduction

Leaflet: Information for the user

Zoviduo 50 mg/g and 10 mg/g Cream

Aciclovir and Hydrocortisone

Read the entire leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this leaflet or as indicated by your healthcare professional exactly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms persist 5 days after completing treatment.

Contents of the leaflet

1. What is Zoviduo and what is it used for
2. What you need to know before using Zoviduo
3. How to use Zoviduo
4. Possible side effects
5. Storage of Zoviduo
6. Package contents and additional information

1. What is Zoviduo and what is it used for

Zoviduo contains two active ingredients: aciclovir and hydrocortisone. Aciclovir is an antiviral that helps combat the virus that causes cold sores. Hydrocortisone is a moderately potent steroid that reduces the inflammation associated with cold sores.

Zoviduo cream is used for the treatment of the first signs and symptoms (e.g., tingling sensation, itching, or redness) of cold sores on the lips and surrounding skin to reduce the possibility of cold sore progression to blisters in adults and adolescents (12 years and older).

Even if your cold sore develops into a blister, Zoviduo will shorten the healing process by approximately 12 to 24 hours, compared to any cream without the active ingredients. A cold sore is caused by a virus called the herpes simplex virus. The virus causes blisters and ulcers, mainly on the lips, but sometimes also on the skin near them. Cold sores can develop when the immune system is weakened, for example, when you have a cold or other infection. Stress, sunlight, cold temperatures, or menstruation can also trigger a cold sore.

You should consult a doctor if your symptoms persist 5 days after completing treatment.

2. What you need to know before using Zoviduo

Do not useZoviduo

• if you are allergic to aciclovir, valaciclovir, hydrocortisone, or any of the other components of this medication (listed in section 6)
• for any other skin infection that is not a cold sore

Warnings and precautions

Use Zoviduo only on cold sores and the area around your lips.

Consult your doctor if you have severe recurrent cold sores to check that you do not have any underlying health problems.

Do not useZoviduo

• in the eye, inside the mouth or nose, or on the genitals
• to treat genital herpes
• if your immune system is not working properly (e.g., if you have had a bone marrow transplant or have HIV) or if you have been diagnosed with a weakened immune system.
• with a dressing such as a patch or bandage for cold sores

Wash your hands before and after application to avoid making the cold sore worse or transmitting the infection to another person.

Consult your doctor if you experience blurred vision or other changes in your vision.

Do not use for more than 5 days.

Children

Do not apply this medication to children under 12 years of age, as it is not known if it works in them or if it is safe for them to use.

UsingZoviduowith other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications, including those obtained without a prescription.

It is not known if the effect of Zoviduo can be affected by the use of other medications at the same time as Zoviduo.

UsingZoviduowith food and drinks

Do not apply the cream just before eating, as the cream may then be licked off.

Pregnancy, breastfeedingand fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

This medication should not be used during pregnancy or breastfeeding, unless your doctor considers that the potential benefits outweigh the possibility of unknown risks.

Driving and using machines

Using Zoviduo does not affect your ability to drive or use machines.

Zoviduocontains propylene glycol and cetearyl alcohol

This medication contains 200 mg/g of propylene glycol.

Cetearyl alcohol may cause local skin reactions (such as contact dermatitis).

Zoviduo contains sodium lauryl sulfate

This medication contains 8 mg/g of sodium lauryl sulfate.

Sodium lauryl sulfate may cause local skin reactions (such as a burning or stinging sensation) or increase skin reactions caused by other products when applied to the same area.

3. How to use Zoviduo

Follow the administration instructions for this medication contained in this leaflet or as indicated by your doctor or pharmacist exactly. If you are unsure, ask your doctor or pharmacist.

For external use only.

Do not use more than the recommended dose.

Adults and children 12 years and older:

Apply the cream five times a day for 5 days (i.e., approximately every 3-4 hours while awake). It is recommended to start treatment as soon as possible, preferably with the first signs or symptoms (e.g., tingling sensation, redness, or itching).

Do not use for more than 5 days. You should consult a doctor if your symptoms persist 5 days after completing treatment.

Method of administration

Wash your hands before and after application to avoid making the cold sore worse or infecting another person.

If you develop an ulcer, do not touch the ulcer more than necessary to avoid spreading the infection to other areas of the body or to the eyes.

If you use moreZoviduothan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

If you forget to useZoviduo

If you miss a dose, apply as soon as you remember and continue as before.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Stop using this medication and contact your doctor immediately if you experience any of the following symptoms of an allergic reaction (very rare: may affect up to 1 in 10,000 people):

• swelling of the face, tongue, or throat, which may result in difficulty swallowing or breathing
• hives

The following side effects are ordered by frequency:

Common (may affect up to 1 in 10 people):

• dryness or flaking of the skin

Uncommon (may affect up to 1 in 100 people):

• burning, tingling, or stinging may occur occasionally directly after application.
• itching

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

• redness of the skin
• changes in skin color

Frequency not known:

• blurred vision

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Zoviduo

Keep this medication out of sight and reach of children. Store at a temperature below 25°C. Do not refrigerate or freeze. Do not use this medication after the expiration date shown on the carton and tube after EXP. The expiration date is the last day of the month indicated.

Validity period after first opening the tube: 3 months. Do not use this medication if you notice that the cream has changed in appearance and/or texture.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Zoviduo

• The active ingredients are aciclovir and hydrocortisone. One gram of cream contains 50 mg of aciclovir and 10 mg of hydrocortisone.
• The other ingredients are liquid paraffin, propylene glycol, isopropyl myristate, sodium lauryl sulfate, cetearyl alcohol, soft white paraffin, poloxamer 188, citric acid monohydrate, sodium hydroxide, hydrochloric acid, and purified water.

Appearance of the product and package contents

Each tube contains 2 grams of Zoviduo cream. Zoviduo is white to yellowish in color. The tube is made of laminated plastic or aluminum.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Haleon Spain, S.A.

Paseo de la Castellana, 259D, 32nd floor,

28046 Madrid, Spain

Manufacturer:

Haleon Denmark ApS

Delta Park 37, 2665,

Vallensbæk Strand, Denmark

Haleon Belgium NV

Da Vincilaan 5,

1930 Zaventem,

Belgium

Haleon - Gebro Consumer Health GmbH

Bahnhofbichi 13,

6391 Fieberbrunn,

Austria

Haleon Germany GmbH

Barthstraße 4, 80339, Munich

Germany

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

Zovirax Duo: Belgium, Bulgaria, Croatia, Czech Republic, Estonia, Germany, Hungary, Ireland, Latvia, Luxembourg, Netherlands, Poland, Portugal, Romania, Slovakia.

Zoviduo: Cyprus, Denmark, Greece, Iceland, Finland, Lithuania, Malta, Norway, Slovenia, Spain, Sweden.

Activir Duo: Austria.

Date of the last revision of this leaflet: February 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/