Label: information for the user

Aciclovir Aurovitas 50 mg/g cream EFG

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

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you, and you must not give it to other people, although

they may have the same symptoms as you, as it may harm them.

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

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

2. What you need to know before starting to use Aciclovir Aurovitas cream.

3. How to use Aciclovir Aurovitas cream.

4. Possible adverse effects.

5. Storage of Aciclovir Aurovitas cream.

6. Contents of the package andadditionalinformation.

Aciclovir Aurovitas 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, and cold sores.

No use Aciclovir Aurovitas:

If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).

• If you think this affects you, do not use aciclovir cream until you consult your doctor.

Advertencias y precauciones

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

Before using aciclovir cream, your doctor will need to know:

• Whether 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 affects you, so that they can decide whether you should switch to an oral presentation.

You should avoid contact of the cream with your eyes, and if it occurs, wash abundantly with water and consult an ophthalmologist if necessary. Do not apply the product inside the mouth, nose, or vagina, as it would cause local irritation.

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

You should not exceed the recommended frequency of applications or duration of treatment.

To avoid contagions:

• Wash your hands after applying the product.
• Do not put the lesion on the lip in contact with other areas of the body or with the skin of other people, especially infants and children. While the lesion persists, try not to rub the sheets with your lips if you sleep with someone else, do not share towels and use paper towels and tissues to avoid re-infecting yourself.

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

This medication does not prevent subsequent outbreaks or reappearance of symptoms.

Niños y adolescentes

For instructions on administering the medication, see section 3.

Administration in children should be carried out under medical supervision.

Otros medicamentos y Aciclovir Aurovitas crema

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

Embarazo y lactancia

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Embarazo

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

Lactancia

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

Conducción y uso de máquinas

The influence of aciclovir on driving or using machines is negligible or insignificant.

Aciclovir Aurovitas crema contiene alcohol cetílico y propilenglicol

As it contains propilenglicol, it may cause skin irritation.

As it contains cetomacrogol, it may cause local skin reactions (such as contact dermatitis).

Aciclovir Aurovitas crema contiene sodio

This medication contains less than 1 mmol of sodium (23 mg) per application; this is essentially “sodium-free”.

Cutaneous use.

Follow exactly the administration instructions of Aciclovir Aurovitas indicated by your doctor or pharmacist. In case of doubt, consult 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 important to start 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 beforehand, 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 aciclovir cream should be spaced four hours apart, omitting the application at night. The suggested hours are: 7 h, 11 h, 15 h, 19 h, and 23h.
• Treatment should be continued for 5 days. If no cure has been achieved in 5 days, treatment may be extended for 5 more days 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, wash your hands to prevent the spread to other areas of the body or the transmission to other people.

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

Your doctor will indicate the duration of treatment with Aciclovir Aurovitas. Do not discontinue treatment beforehand, as the cure may not be complete.

If you use more Aciclovir Aurovitas than you should

If you use more aciclovir 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 forgot to use Aciclovir Aurovitas

In case of forgotten dose, administer it as soon as possible, however, if it is close to the time of your next application, omit the forgotten dose and wait for the next one.

Do not use a double dose to compensate for the forgotten 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 Aciclovir Aurovitas cream

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

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

Likeall medications, Aciclovir Aurovitas may have adverse effects, although not everyone will experience them.

Adverse effects that are infrequent (may affect up to 1 in 100 people):

Adverse effects that are rare (may affect up to 1 in 1,000 people):

Adverse effects that are very rare (may affect up to 1 in 10,000 people):

The signs of hypersensitivity may include:

Contact a doctor immediately if you experience any of these symptoms. Stop using aciclovir 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 Aciclovir Aurovitas out of the sight and reach of children.

Do not use Aciclovir Aurovitas after the expiration date indicated on the box. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point(or any other medication waste collection system) at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Aciclovir Aurovitas 50 mg/g cream:

Each gram of cream contains 50 mg of aciclovir.

estearate of polyoxyethylene-30 (Arlatone 983 S), dimethicone, cetyl alcohol, liquid paraffin

white vaseline, 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 packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid,

Spain

Responsible for manufacturing:

Farmalabor, Pharmaceutical Products S.A.

Zona Industrial de Condeixa-a-Nova

Condeixa-a-Nova,3150-194,

Portugal

Date of the last review of this leaflet:October 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Deviceshttp://www.aemps.gob.es