Prospecto: information for the user

Zoviduo 50 mg/g and 10 mg/g Cream

Aciclovir and Hydrocortisone

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your healthcare professional.

- Keep this prospect, as you may need to read it again.

- If you need advice or more information, consult your pharmacist.

- If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

1. What isZoviduoand for what it is used

2. What you need to know before starting to useZoviduo

3. How to useZoviduo

4. Possible adverse effects

5. Storage ofZoviduo

6. Contents of the package and additional information

Zoviduocontains two active ingredients: aciclovir and hydrocortisone. Aciclovir is an antiviral that helps to combat the virus that causes fever. The hydrocortisone is a moderate potency steroid that reduces the inflammation associated with fever.

Zoviduocream is used for the treatment of the first signs and symptoms (for example, tingling, itching or redness) of herpes on the lips and the skin near them to reduce the possibility of progression of herpes labial to blisters in adults and adolescents (12 years and older).

Even if your fever turns into a blister,Zoviduowill shorten the healing process between 12 and 24 hours approximately, if compared to any cream without active ingredients.

Herpes labial is caused by a virus called herpes simplex virus. The virus causes blisters and ulcers mainly on the lips, but sometimes also on the skin near them. Herpes labial can develop when the immune system is weakened, for example, when having a cold or other infection. Stress, sunlight, cold temperatures or menstruation can also trigger a herpes labial.

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

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 herpes labialis

Warnings and precautions

UseZoviduoonly on herpes labialis and the surrounding area of your lips.

Consult your doctor if you have severe recurrent herpes labialis, to check that you do not have any underlying health problem.

Do not useZoviduo

- in the eye, inside the mouth or nose, or in the genitals

- to treat genital herpes

- if your immune system does not function properly (for example if you have undergone a bone marrow transplant or have HIV) or if you have been diagnosed with a weakened immune system.

- with a bandage as a dressing or a patch for fever

Wash your hands before and after application to avoid worsening the herpes labialis or transmitting the infection to another person.

Consult your doctor if you experience blurred vision or other visual disturbances.

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 whether it acts on them or is safe for them to use.

Use ofZoviduowith other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those acquired without a prescription.

It is not known whether the effect ofZoviduomay be affected by the use of other medications at the same time asZoviduo.

Use ofZoviduowith food and drinks

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, believe you may be pregnant, or intend 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 operating machines

The use ofZoviduodoes not affect your ability to drive and operate machines.

Zoviduocontains propylenglycol and cetearyl alcohol

This medication contains 200mg/g of propylenglycol.

Cetearyl alcohol may cause local reactions on the skin (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 reactions on the skin (such as burning or stinging sensation) or increase skin reactions caused by other products when applied to the same area.

Follow exactly the administration instructions for this medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

For use on the skin only.

Do not use more than the recommended dose.

Adults and children 12 years of age and older:

Apply the cream five times a day for 5 days (that is, approximately every 3-4 hours while awake). It is recommended to start treatment as soon as possible, preferably with the first signs or symptoms, (for example, tingling, 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 worsening or infecting others with herpes labial.

If you develop a sore, do not touch the sore 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested

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

If you forgot to useZoviduo

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

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

- Swelling of the face, tongue, or throat, which may result in difficulty swallowing or breathing

- Urticaria

The following adverse effects are listed in order of frequency with which they may occur:

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

- Dryness or flaking of the skin

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

- Transient burning, tingling, or stinging sensations may occur at times directly after application.

- Itching

Rare (may affect up to 1 in 1,000 people):
- Redness of the skin
- Changes in skin color

- A localized erythema or skin irritation with itching and a burning sensation at the site of application of the cream.

Unknown frequency:

- Blurred vision

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the 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 that appears on the box and the tube after CAD. The expiration date is the last day of the month indicated.

Validity period after the first opening of the tube: 3 months.

Do not use this medication if you observe that the cream has changed appearance and/or texture.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medicines. By doing so, you will help protect the environment.

Composition of Zoviduo

- The active principles are aciclovir and hydrocortisone. One gram of cream contains 50 mg of aciclovir and 10 mg of hydrocortisone.
- The other components 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 contents of the packaging

Cada tubo contains 2 grams of creamZoviduo.Zoviduois white to yellowish in color. The tube is made of laminated polyethylene with aluminum or aluminum.

Holder of the authorization and responsible for the manufacture

Holder of the authorization:

Haleon Spain, S.A

C/Severo Ochoa, 2, P.T.M

28760Tres Cantos

Madrid

Spain

Responsible for the manufacture:

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

Barthstraβe 4, 80339, Munich

Germany

This medicine is authorized in the member states of the European Economic Area with 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.

Last review date of this leaflet: February 2021

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/