ZOVIRAX 50 mg/g CREAM

Introduction

Leaflet: information for the user

Zovirax 50 mg/g cream

Aciclovir

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What is Zovirax cream and what is it used for

Zovirax contains aciclovir, an active ingredient belonging to the 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.

2. What you need to know before starting to use Zovirax cream

Do not use Zovirax cream

• if you are allergic to aciclovir, valaciclovir, propylene glycol, or any of the other components 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 works worse or your body is less able to fight infections (e.g., if you have HIV or AIDS, or if you have received a bone marrow transplant).

If you think this applies to you, consult your doctor to decide if you should switch to an oral administration form.

Aciclovir should not be applied to mucous membranes, such as the mouth, eyes, or vagina, as it may be irritating. You should be particularly careful to avoid accidental introduction into the eyes. If accidental contact with the eyes occurs, rinse with plenty of water and consult an ophthalmologist if necessary.

Genital herpes can be transmitted through sexual contact, even if the partner does not show symptoms. You should avoid sexual contact if a partner has signs or symptoms of genital herpes. Aciclovir does not prevent the transmission of herpes.

Do not exceed the recommended application frequency or treatment duration.

Children and adolescents

To consult the administration instructions for the medicine, see section 3.

Administration in children should always be done under medical supervision.

Using Zovirax cream with other medicines

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

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

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

Consult your doctor before using Zovirax cream.

Driving and using machines

The influence on driving or using machines is nil or insignificant.

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

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

3. How to use Zovirax cream

Follow the administration instructions for the medicine indicated by your doctor or pharmacist exactly. If in doubt, ask your doctor or pharmacist.

Remember to use your medicine.

It should be applied to the lesions or impending lesions as soon as possible after the onset of the infection. It is essential to start treatment during the period when the lesions have not yet appeared or when they first appear.

Your doctor will indicate the duration of treatment. Do not stop treatment before completing the recommended duration, as the infection caused by the virus may return.

Adults and children

• Apply a thin layer of cream to the affected area five times a day.
• Applications of Zovirax cream should be spaced four hours apart, omitting the nighttime application. The suggested schedules are: 7 am, 11 am, 3 pm, 7 pm, and 11 pm.
• Treatment should be continued for 5 days. If healing has not occurred in 5 days, treatment may be extended for an additional 5 days, up to a total of 10 days.

• If symptoms worsen or no improvement is observed within 10 days of treatment, stop using 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 medicines
• wash your hands always before and after using the cream to avoid spreading to other areas of the body or infecting others.

If you think the effect of Zovirax cream is too strong or too weak, tell 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. Overdose is unlikely with this medicine.

If you experience an overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Zovirax cream

If you forget an application, do 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 make up for missed doses; simply continue with the usual treatment as soon as possible.

Do not exceed the recommended application frequency or treatment duration.

If you stop treatment with Zovirax cream

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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

transient burning or itching after application

mild dryness or flaking of the skin

itching sensation.

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

redness of the skin

skin rash.

Very rare side effects(may affect up to 1 in 10,000 people):

• Immediate hypersensitivity reactions (allergic reactions).

Signs of hypersensitivity may include:

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

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zovirax cream

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

Do not store above 25°C. Do not refrigerate. Keep in the original packaging.

Do not use this medicine after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Zovirax cream

• The active ingredient is aciclovir. Each gram of cream contains 50 mg of aciclovir.
• The other ingredients are: cetyl 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 package contents

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

Available in 2, 10, and 15 gram tubes.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Haleon Spain, S.A.

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

28046 Madrid, Spain

Manufacturer:

Haleon Germany GmbH

Barthstrasse 4

80339 Munich

Germany

Date of the last revision of this leaflet:October 2020.

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