ACICLOVIR ARISTO 50 mg/g CREAM

Introduction

Leaflet: Information for the user

Aciclovir Aristo 50 mg/g cream EFG

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

-Keep this leaflet since you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribed to you only and should not be given 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 Aciclovir Aristo cream and what is it used for
2. What you need to know before starting to use Aciclovir Aristo cream
3. How to use Aciclovir Aristo cream
4. Possible side effects
5. Storage of Aciclovir Aristo cream
6. Package contents and additional information

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

Aciclovir Aristo cream contains aciclovir, an active ingredient belonging to the group of medications 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 Aciclovir Aristo cream

Do not use Aciclovir Aristo cream:

• If you are allergic to aciclovir, valaciclovir, propylene glycol, or any of the other components of this medication (listed in section 6).
• If you think this affects you, do not use Aciclovir Aristo cream until you have consulted your doctor.

Warnings and precautions

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

Be particularly careful with Aciclovir Aristo cream

Before using Aciclovir Aristo cream, your doctor needs to know:

• If recurrences are frequent, if you have a condition where your immune system functions worse or your body is less able to fight infections (e.g., if you have HIV or AIDS or 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 administration form.

It is not recommended to apply aciclovir to mucous membranes, such as the mouth, eyes, or vagina, as it may be irritating. You should be 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 medication, see section 3.

Application in children should always be done under medical supervision.

Use of Aciclovir Aristo with other medications

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

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

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

Consult your doctor before using Aciclovir Aristo cream

Driving and using machines

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

Important information about some of the components of Aciclovir Aristo

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

3. How to use Aciclovir Aristo

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubts, ask your doctor or pharmacist.

Remember to use your medication.

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

Your doctor will indicate the treatment duration. Do not stop treatment before completing the recommended duration, as the infection may recur.

Adults and children

• Apply a thin layer of cream to the affected area five times a day.
• Aciclovir Aristo cream applications should be spaced four hours apart, omitting the nighttime application. 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 Aciclovir Aristo cream

• Aciclovir Aristo cream should only be applied to the skin
• Aciclovir Aristo cream is not for oral, ophthalmic, or vaginal use
• Do not mix Aciclovir Aristo with anything, including water or other medications
• 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 Aciclovir Aristo is too strong or too weak, inform your doctor or pharmacist.

If you use more Aciclovir Aristo cream than you should

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

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

If you forget to use Aciclovir Aristo 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 forgotten application.

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

Do not exceed the recommended application frequency or treatment duration

If you interrupt treatment with Aciclovir Aristo cream

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience 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 your doctor immediately if you experience any of these symptoms. Stop using Aciclovir Aristo cream.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use, website: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Aciclovir Aristo

Keep this medication out of sight and reach of children.

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

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

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

6. Package contents and additional information

Composition of Aciclovir Aristo cream

• The active ingredient is aciclovir. Each gram of cream contains 50 mg of aciclovir.
• The other components are: liquid paraffin, light white paraffin, cetyl alcohol emulsifier type A, methylparaben, propylparaben, purified water.

Appearance of the product and package contents

Aciclovir Aristo cream is a white cream.

It is presented in cardboard boxes containing aluminum tubes with 15 g or 2 g of cream.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer:

FARMASIERRA MANUFACTURING, S.L.

Carretera de Irún, Km 26,600

28700 San Sebastián de los Reyes

Madrid

O

ARAFARMA GROUP, S.A.

C/ Hacienda de Pavones, 167

28030 Madrid

Date of the last revision of this leaflet: December 2023

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