Aciclovir Aurovitas 50 mg/g cream EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aciclovir Aurovitas 50 mg/g cream EFG

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Aciclovir Aurovitas cream is and what it is used for.
2. What you need to know before using Aciclovir Aurovitas cream.
3. How to use Aciclovir Aurovitas cream.
4. Possible adverse effects.
5. How to store Aciclovir Aurovitas cream.
6. Contents of the pack and other information.

1. What Aciclovir Aurovitas cream is and what it is used for

Aciclovir Aurovitas contains aciclovir, the active substance which 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.

2. What you need to know before using Aciclovir Aurovitas cream

Do not use Aciclovir Aurovitas:

If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

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

Warnings and precautions

Talk to your doctor or pharmacist before using this medicine.

Before using aciclovir cream, your doctor needs to know:

• If you have frequent recurrences, or if you have a condition in which your immune system functions poorly or your body is less able to fight infections (for example, if you have HIV infection or AIDS, or if you 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.

Avoid contact of the cream with the eyes; if contact occurs, rinse thoroughly with water and consult an ophthalmologist if necessary. Do not apply the product inside the mouth, nose, or vagina, as it may cause local irritation.

Genital herpes can be transmitted through sexual contact, even if the partner does not have symptoms. Sexual contact should be avoided if either partner shows signs or symptoms of genital herpes. Aciclovir does not prevent the transmission of herpes.

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

To avoid spreading the infection:

• Wash your hands after applying the product.
• Do not let the lip lesion come into contact with other areas of your body or with the skin of other people, especially infants and children. While the lesion persists, avoid contact between your lips and bed linens if sharing a bed, do not share towels, and use paper tissues and napkins to prevent self-reinfection.

If the lesion worsens or has not healed within 10 days, stop treatment and consult your doctor.

This medicine does not prevent future outbreaks or recurrence of symptoms.

Children and adolescents

For instructions on administration, see section 3.

Administration in children should always be under medical supervision.

Other medicines and Aciclovir Aurovitas cream

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 aciclovir cream during pregnancy.

Breastfeeding

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

Driving and use of machines

The effect of aciclovir on driving or operating machinery is negligible or none.

Aciclovir Aurovitas cream contains cetyl alcohol and propylene glycol

Due to the presence of propylene glycol, it may cause skin irritation.

Due to the presence of cetyl alcohol, it may cause local skin reactions (such as contact dermatitis).

Aciclovir Aurovitas cream contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per application; hence, it is essentially "sodium-free".

3. How to use Aciclovir Aurovitas cream

For topical use only.

Follow exactly the administration instructions for Aciclovir Aurovitas provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Remember to use your medication.

It should be applied to the lesions or to the areas where lesions are about to appear as soon as possible after the onset of infection. It is important to begin treatment for recurrent episodes during the period when lesions have not yet appeared or when they first appear.

Your doctor will advise you on the duration of treatment. Do not stop treatment prematurely, as the viral infection may recur.

Adults and children

• Apply a thin layer of cream to the affected area five times daily.
• Applications of aciclovir 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.
• 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.
• If symptoms worsen or no improvement is observed within 10 days of treatment, stop using the cream and consult your doctor.

Application of Aciclovir Aurovitas cream

• Aciclovir cream should only be applied to the skin.
• Aciclovir cream is not for oral, ophthalmic, or vaginal use.
• Do not mix aciclovir cream with anything, including water or other medications.

After applying aciclovir cream, hands should be washed to prevent spreading the infection to other parts of the body or to other people.

If you think that the effect of Aciclovir Aurovitas is too strong or too weak, inform your doctor or pharmacist.

Your doctor will advise you on the duration of treatment with Aciclovir Aurovitas. Do not stop treatment prematurely, as healing may not be complete.

If you use more Aciclovir Aurovitas than you should

If you use more aciclovir cream than recommended, carefully remove the excess. Overdose symptoms are unlikely with this medication.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Aciclovir Aurovitas

If you miss a dose, apply it as soon as possible. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular schedule.

Do not use a double dose to make up for missed doses; simply continue your treatment as usual as soon as possible.

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

If you interrupt treatment with Aciclovir Aurovitas cream

Do not interrupt treatment with Aciclovir Aurovitas cream without consulting your doctor.

It is important that you use aciclovir cream for the full prescribed duration to completely eliminate the infection.

4. Possible adverse effects

Like all medicines, Aciclovir Aurovitas may have adverse effects, although not everyone experiences 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.
• Itching sensation.

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 body parts (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 aciclovir 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 Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aciclovir Aurovitas cream

Keep Aciclovir Aurovitas out of the sight and reach of children.

Do not use Aciclovir Aurovitas after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point (or any other medicine waste collection system) at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aciclovir Aurovitas 50 mg/g cream:

• The active substance is aciclovir.

Each gram of cream contains 50 mg of aciclovir.

• The other components (excipients) are: mixture of glyceryl monostearate and
  polyoxyethylene-30 stearate (Arlatone 983 S), dimethicone, cetostearyl alcohol, liquid
  paraffin, white soft paraffin, propylene glycol (each gram of cream contains 15 mg of
  propylene glycol), sodium hydroxide and purified water.

Appearance of the product and contents of the pack

Aciclovir Aurovitas 50 mg/g cream is available in tubes of 2 g and 15 g.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid,
Spain

Manufacturer:

Farmalabor, Produtos Farmacêuticos S.A.
Zona Industrial de Condeixa-a-Nova
Condeixa-a-Nova, 3150-194,
Portugal

Date of the most recent revision of this leaflet: October 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios) http://www.aemps.gob.es