Label:Information for the User

Zovirax 50 mg/g Cream

Aciclovir

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

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.

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

Zovirax contains aciclovir, an active ingredient that belongs to a group of medicines called antivirals.

It is indicated for the treatment of skin infections caused by the herpes simplex virus, including initial genital herpes and its recurrences and cold sores.

Do not use Zovirax cream

• if you are allergic to aciclovir, valaciclovir, propylene glycol or any of the other ingredients of this medicine (listed in section 6).

?If you think this applies to you, do not use Zovirax cream until you have consulted your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine.

Be particularly careful with Zovirax cream

Before using Zovirax cream, your doctor needs to know:

• if recurrences are frequent, if you have a condition in which your immune system functions worse or your body is less able to fight infections (for example, if you have an HIV or AIDS infection or if you have received a bone marrow transplant).

?Consult your doctor if you think this applies to you, so that they can decide whether you should switch to an oral presentation.

Aciclovir should not be applied to mucous membranes such as the mouth, eyes or vagina as it may be irritating. Special care should be taken to avoid accidental contact with the eyes. If accidental contact with the eyes occurs, wash with plenty of water and consult an ophthalmologist if necessary.

Genital herpes can be transmitted by sexual contact, even if the partner does not show symptoms. Avoid sexual contact if a partner shows signs or symptoms of genital herpes. Aciclovir does not prevent the transmission of herpes.

Do not exceed the recommended frequency of applications or duration of treatment.

Children and adolescents

For administration instructions, see section 3.

Administration in children should always be under medical supervision.

Use of Zovirax cream with other medicines

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine, including those obtained without a prescription.

Pregnancy and breastfeeding

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

Pregnancy

Your doctor will assess the benefit for you and the risk to your baby of using Zovirax cream during pregnancy.

Breastfeeding

Your doctor will assess the benefit for you and the risk to your baby of using Zovirax cream during breastfeeding.

Consult your doctor before using Zovirax cream.

Driving and operating machinery

The influence on driving or operating machinery is negligible or insignificant.

Zovirax cream contains cetearyl alcohol, propylene glycol and sodium lauryl sulfate

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetearyl alcohol.

This medicine contains 400 mg of propylene glycol in each gram of cream.

Propylene glycol may cause skin irritation.

Do not use this medicine in babies under 4 weeks with open wounds or large areas of damaged skin (such as burns) without consulting your doctor or pharmacist first.

This medicine contains 7.5 mg of sodium lauryl sulfate in each gram of cream.

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

Follow exactly the medication administration instructions indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Remember to use your medication.

It must be applied to the lesions or imminent lesions as soon as possible after the onset of the infection.It is essential to start the treatment of recurrent episodes during the period when lesions have not yet appeared or when lesions appear for the first time.

Your doctor will indicate the duration of treatment. Do not discontinue treatment as the infection caused by the virus may recur.

Adults and children

• Apply a thin layer of cream to the affected area five times a day.
• The applications of Zovirax cream should be spaced four hours apart, omitting the application at night.The suggested times are: 7 h, 11 h, 15 h, 19 h, and 23h.
• Treatment should be continued for 5 days. If no cure is observed in 5 days, treatment may be extended for 5 more days up to a total of 10 days.

• If symptoms worsen or no improvement is observed within 10 days of treatment, discontinue use of the cream and consult your doctor.

Application of Zovirax cream

• Zovirax cream should only be applied to the skin
• Zovirax cream is not for oral, ophthalmic, or vaginal use
• Do not mix Zovirax cream with anything, including water or other medications
• Wash your hands thoroughly before and after using the cream to avoid spreading to other areas of the body or infecting others.

If you estimate that the action of Zovirax cream is too strong or too weak, inform your doctor or pharmacist.

If you use more Zovirax cream than you should

If you use more Zovirax cream than you should, carefully remove the excess. It is unlikely that overdose cases will occur with this medication.

?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 forget to use Zovirax cream

In case of forgetting an application, apply it as soon as possible, however,if it is close to the time of your next application, omit the missed application.

Do not use a double dose to compensate for the missed doses, simply continue with the usual treatment as soon as possible.

Do not exceed the recommended frequency of applications or duration of treatment.

If you interrupt treatment with Zovirax cream

Do not discontinue treatment with Zovirax cream without consulting your doctor.

It is essential to use Zovirax cream for the indicated time to completely eliminate the infection.

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

Less Common Adverse Effects(may affect up to 1 in 100 people):

?transient burning or itching after application

?mild dryness or peeling of the skin

?itching sensation.

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

?skin redness

?skin eruption.

Very Rare Adverse Effects(may affect up to 1 in 10,000 people):

• Immediate hypersensitivity reactions (allergic reactions).

Hypersensitivity signs may include:

• swelling of the face, lips, tongue, or other body parts (angioedema)
• skin eruption, itching, or urticaria
• shortness of breath, difficulty breathing, or wheezing
• unexplained fever and feeling of fainting, particularly when standing.

?Contact a doctor immediately if you experience any of these symptoms. Stop using Zovirax cream.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 25 °C. Do not refrigerate. Store in the original packaging.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

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

Composition of Zovirax cream

• The active ingredient is aciclovir. Each gram of cream contains 50 mg of aciclovir.
• The other components are: cetearyl alcohol, propylene glycol (E-1520), poloxamer 407, sodium lauryl sulfate, white petrolatum, liquid petrolatum, dimethicone, arlacel 165 and purified water.

Appearance of the product and contents of the packaging

Zovirax cream is a white or almost white cream that is packaged in aluminum tubes with a plastic cap. The tubes are packaged in cardboard boxes.

Presentations in tubes of 2, 10 and 15 grams.

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization:

Haleon Spain, S.A.

C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Manufacturer responsible:

Haleon Germany GmbH

Barthstrasse 4

80339 Munich

Germany

Last review date of this leaflet:October 2020.

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