Zoviduo 50 mg/g + 10 mg/g cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Zoviduo 50 mg/g and 10 mg/g Cream
Aciclovir and Hydrocortisone
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your healthcare professional.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if these are effects 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
- What Zoviduo is and what it is used for
- What you need to know before using Zoviduo
- How to use Zoviduo
- Possible side effects
- How to store Zoviduo
- Contents of the pack and other information
1. What Zoviduo is and what it is used for
Zoviduo contains two active substances: aciclovir and hydrocortisone. Aciclovir is an antiviral agent that helps fight the virus causing cold sores. Hydrocortisone is a moderately potent corticosteroid that reduces inflammation associated with cold sores.
Zoviduo cream is used for the treatment of early signs and symptoms (e.g., tingling, itching, or redness) of herpes on the lips and surrounding skin, to reduce the likelihood of progression to cold sore blisters in adults and adolescents (12 years of age and older).
Even if your cold sore develops into a blister, Zoviduo will shorten the healing time by approximately 12 to 24 hours compared to a cream without these active ingredients. A cold sore is caused by a virus called the herpes simplex virus. The virus causes blisters and ulcers, primarily on the lips, but sometimes also on the nearby skin. Cold sores may develop when the immune system is weakened, for example during 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 use Zoviduo
- if you are allergic to aciclovir, valaciclovir, hydrocortisone, or any of the other ingredients of this medicine (listed in section 6)
- for any other skin infection that is not cold sores
Warnings and precautions
Use Zoviduo only for cold sores and on the area around your lips.
Consult your doctor if you have severe recurrent cold sores, to check whether you might have an underlying health condition.
Do not use Zoviduo
- in the eye, inside the mouth or nose, or on the genitals
- to treat genital herpes
- if your immune system is not working properly (for example, 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 bandage or a cold sore patch
Wash your hands before and after application to avoid worsening the cold sore or spreading the infection to someone else.
Consult your doctor if you experience blurred vision or other changes in eyesight.
Do not use for longer than 5 days.
Children
Do not apply this medicine to children under 12 years of age, as it is not known whether it works or is safe for them.
Using Zoviduo with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
It is not known whether the effect of Zoviduo may be affected by using other medicines at the same time as Zoviduo.
Using Zoviduo with food and drink
Do not apply the cream immediately before eating, as the cream may then be licked off.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy or breast-feeding unless your doctor considers the potential benefits to outweigh the possibility of unknown risks.
Driving and using machines
The use of Zoviduo does not affect your ability to drive or operate machinery.
Zoviduo contains propylene glycol and cetostearyl alcohol
This medicine contains 200 mg/g of propylene glycol.
Cetostearyl alcohol may cause local skin reactions (such as contact dermatitis).
Zoviduo contains sodium lauryl sulfate
This medicine contains 8 mg/g of sodium lauryl sulfate.
Sodium lauryl sulfate may cause local skin reactions (such as stinging or burning sensations) or increase skin reactions caused by other products when applied to the same area.
3. How to use Zoviduo
Follow exactly the instructions for use of this medicine provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
For external use only.
Do not use more than the recommended dose.
Adults and children aged 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 at the first signs or symptoms (e.g., tingling sensation, redness, or itching).
Do not use for longer 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 the cold sore or spreading the infection to another person.
If you develop an ulcer, avoid touching it more than necessary to prevent spreading the infection to other areas of the body or to the eyes.
If you use more Zoviduo than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
If you forget to use Zoviduo
If you miss a dose, apply it as soon as you remember and then continue as before.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Stop using this medicine and contact your doctor immediately if you experience any of the following symptoms of an allergic reaction (very rare adverse 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
- hives
The following adverse effects are listed according to their frequency of occurrence:
Frequent (may affect up to 1 in 10 people):
- dryness or peeling of the skin
Uncommon (may affect up to 1 in 100 people):
- transient burning, tingling or stinging may occasionally occur immediately after application
- itching
Rare (may affect up to 1 in 1,000 people):
- redness of the skin
- changes in skin colour
- erythema or localized skin irritation with itching and burning sensation at the site of cream application
Frequency not known:
- blurred vision
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Zoviduo
Keep this medicine out of the sight and reach of children. Store below 25°C. Do not refrigerate or freeze. Do not use this medicine after the expiry date stated on the carton and tube after EXP. The expiry date refers to the last day of the month indicated.
Usable period after first opening of the tube: 3 months. Do not use this medicine if you notice any changes in the appearance and/or texture of the cream.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the container and other information
Composition of Zoviduo
- The active substances 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, cetostearyl alcohol, soft white paraffin, poloxamer 188, citric acid monohydrate, sodium hydroxide, hydrochloric acid, and purified water.
Appearance of the product and contents of the container
Each tube contains 2 grams of Zoviduo cream. Zoviduo is white to yellowish in colour. The tube is made of laminated polyethylene-aluminum plastic or aluminum.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Haleon Spain, S.A.
Paseo de la Castellana, 259D, planta 32,
28046 Madrid, Spain
Manufacturers:
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 medicinal product is authorised in the European Economic Area member states 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 most recent review of this leaflet: February 2021
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/