Aciclovir Aristo 50 mg/g cream EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aciclovir Aristo 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 only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.

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

Leaflet contents:

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

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

Aciclovir Aristo cream contains aciclovir, an active ingredient that 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, as well as cold sores.

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

Do not use Aciclovir Aristo 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 Aciclovir Aristo cream until you have consulted your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before using this medicine.

Take special care with Aciclovir Aristo cream

Before using Aciclovir Aristo 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 or AIDS infection, 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 on 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 your 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 the transmission of herpes.

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

Children and adolescents

For instructions on how to use the medicine, see section 3.

Application in children should always be carried out under medical supervision.

Using Aciclovir Aristo with other medicines

Inform 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, breastfeeding, think you might 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 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 effect on the ability to drive or use machines is none or negligible.

Important information about some of the ingredients of Aciclovir Aristo

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

3. How to use Aciclovir Aristo

Follow exactly the instructions for use of this medicine as given 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 impending lesions as soon as possible after the onset of infection. It is important to start treatment for recurrent episodes during the period when lesions have not yet appeared or as soon as the lesions first appear.

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

Adults and children

• Apply a thin layer of cream to the affected area five times a day.
• Applications of Aciclovir Aristo cream should be spaced approximately 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 maximum of 10 days.
• If symptoms worsen or no improvement is observed within 10 days of treatment, discontinue use of 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.
• Always wash your hands before and after using the cream to prevent spreading the infection to other parts of the body or to other people.

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 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 Aciclovir Aristo cream

If you forget to apply a dose, apply it as soon as possible. However, if it is close to the time for your next dose, skip the missed dose.

Do not use a double dose to make up for forgotten doses; simply continue with your regular dosing schedule as soon as possible.

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

If you stop treatment with Aciclovir Aristo cream

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

It is important to use Aciclovir Aristo cream for the full prescribed duration to completely eliminate the infection.

4. Possible adverse effects

Like all medicines, this medicine may 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 skin dryness or peeling
• 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 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 your doctor immediately if you experience any of these symptoms. Stop using Aciclovir Aristo 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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products at website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aciclovir Aristo

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

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

D o not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aciclovir Aristo cream

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

Appearance of the medicinal product and contents of the pack

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 certain pack 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

28706 San Sebastián de los Reyes

Madrid

or

ARAFARMA GROUP, S.A.

C/ Hacienda de Pavones, 167

28030 Madrid

Date of the most recent revision of this leaflet: December 2023

“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/”