Zovirax 50 mg/g cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Zovirax 50 mg/g cream
Aciclovir
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, ask your doctor or pharmacist.
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This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
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If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Zovirax cream is and what it is used for
- What you need to know before using Zovirax cream
- How to use Zovirax cream
- Possible adverse effects
- How to store Zovirax cream
- Contents of the pack and other information
1. What Zovirax cream is and what it is used for
Zovirax contains aciclovir, an active ingredient belonging 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, as well as cold sores.
2. What you need to know before using Zovirax cream
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
Talk to your doctor or pharmacist before using this medicine.
Take special care with Zovirax cream
Before using Zovirax cream, your doctor needs to know:
- if you have frequent recurrences, or if you have a condition in which your immune system works less effectively or your body is less able to fight infections (for example, if you have HIV or AIDS, or have received a bone marrow transplant).
? Consult your doctor if you think this applies to you, so they can decide whether you should switch to an oral formulation.
Application of aciclovir to mucous membranes such as the mouth, eyes, or vagina is not recommended, as it may be irritating. Take special care to avoid accidental introduction into the eyes. If accidental contact with the eyes occurs, rinse thoroughly with water and consult an ophthalmologist if necessary.
Genital herpes can be transmitted through sexual contact, even if the partner does not have symptoms. Sexual contact should be avoided if one partner shows signs or symptoms of genital herpes. Aciclovir does not prevent transmission of herpes.
Do not exceed the recommended frequency of application or duration of treatment.
Children and adolescents
For instructions on administration of the medicine, see section 3.
Administration in children should always be carried out under medical supervision.
Use of Zovirax cream 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.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 effect on the ability to drive or use machines is none or negligible.
Zovirax cream contains cetostearyl alcohol, propylene glycol, and sodium lauryl sulfate
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetostearyl alcohol.
This medicine contains 400 mg of propylene glycol per gram of cream.
Propylene glycol may cause skin irritation.
Do not use this medicine in infants under 4 weeks of age with open wounds or large areas of damaged skin (such as burns) without first consulting your doctor or pharmacist.
This medicine contains 7.5 mg of sodium lauryl sulfate per 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 exactly the instructions for use of the medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Remember to use your medicine.
It should be applied to the lesions or to areas where lesions are about to appear as soon as possible after the onset of infection. It is important to begin treatment of recurrent episodes during the period when lesions have not yet appeared or when they first appear.
Your doctor will indicate the duration of treatment. Do not stop the treatment prematurely, as the viral infection may recur.
Adults and children
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Apply a thin layer of cream to the affected area five times a day.
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Applications of Zovirax cream should be spaced four hours apart, omitting the nighttime application. Suggested times are: 7 a.m., 11 a.m., 3 p.m., 7 p.m., and 11 p.m.
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Treatment should continue for 5 days. If healing has not occurred within 5 days, treatment may be extended for another 5 days, up to a total of 10 days.
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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 medications.
- Always wash your hands before and after using the cream to prevent spreading the infection to other areas of the body or to other people.
If you think that the effect 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 recommended, carefully remove the excess. Overdose symptoms are unlikely with this medicine.
? In case of overdose or accidental ingestion, contact 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 forget to use Zovirax cream
If you miss a dose, apply it as soon as possible. However, if it is close to the time of your next dose, skip the missed dose.
Do not use a double dose to make up for a missed dose. Simply continue your regular treatment as soon as possible.
Do not exceed the recommended frequency of applications or the recommended duration of treatment.
If you stop treatment with Zovirax cream
Do not interrupt treatment with Zovirax cream without consulting your doctor.
It is important that you use Zovirax cream for the full prescribed duration to completely eliminate the infection.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Uncommon adverse effects (may affect up to 1 in 100 people):
? transient burning or itching after application
? mild dryness or peeling of the skin
? sensation of itching.
Rare adverse effects (may affect up to 1 in 1,000 people):
? redness of the skin
? skin rash.
Very rare adverse 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)
- skin rash, itching, or hives
- shortness of breath, difficulty breathing, or wheezing
- unexplained fever and feeling faint, particularly when standing.
? Contact a doctor immediately if you experience any of these symptoms. Stop using Zovirax cream.
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 may also report them directly through 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 Zovirax cream
Keep this medicine out of sight and reach of children.
Do not store above 25°C. Do not refrigerate. Store in the original packaging.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Zovirax cream
- The active substance is aciclovir. Each gram of cream contains 50 mg of aciclovir.
- The other components are: cetyl stearyl alcohol, propylene glycol (E-1520), poloxamer 407, sodium lauryl sulfate, white soft paraffin, liquid paraffin, dimethicone, arlacel 165 and purified water.
Appearance of the product and contents of the container
Zovirax cream is a white or almost white cream packed in aluminium tubes fitted with a plastic cap. The tubes are packaged in cardboard boxes.
Available pack sizes: 2, 10 and 15 grams.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 most recent revision of this leaflet: October 2020.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es