Label: Information for the User

Aciclovir Aristo 50 mg/g Cream EFG

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

-Keep this label as you may need to refer to it again.

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

-This medication has been prescribed to you alone and should not be given to others, even if they have the same symptoms as you, as it may harm them.

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

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 and cold sores.

Do not use Aciclovir Aristo cream:

- If you are allergic to aciclovir, valaciclovir, propylene glycol, or any of the other ingredients in this medication (listed in section 6).

- If you think this affects you, do not use Aciclovir Aristo cream until you consult your doctor.

Warnings and precautions

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

Be especially careful with Aciclovir Aristo cream

Your doctor needs to know before using Aciclovir Aristo cream:

• If recurrences are frequent, if you have a condition where your immune system functions poorly 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.

Do not apply aciclovir to mucous membranes such as the mouth, eyes, or vagina as it may be irritating. Be especially 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. Avoid sexual contact if a partner shows signs or symptoms of genital herpes.

Aciclovir does not prevent the transmission of herpes.

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

Children and adolescents

For instructions on administering the medication, see section 3.

Application in children should be carried out under medical supervision at all times.

Using Aciclovir Aristo with other medications

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

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

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

Consult your doctor before using Aciclovir Aristo cream

Driving and operating machinery

The influence on driving or operating machinery is negligible 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 cetearyl alcohol.

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

Remember to use your medication.

It must be applied to the lesions or impending lesions as soon as possible after the onset of the infection. It is important to start the treatment of recurrent herpes 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 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.
• Aciclovir Aristo cream should be spaced four hours apart, omitting the application at night. The suggested times are: 7 h, 11 h, 15 h, 19 h, and 23 h.
• Treatment should be continued for 5 days. If no cure is observed in 5 days, treatment may be prolonged for 5 more days up to a total of 10 days.
• If symptoms worsen or no improvement is observed in 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
• Hands should be washed before and after using the cream to avoid spreading to other areas of the body or infecting others.

If you estimate that the action 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 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 Aristo cream

In case of forgetting an application, perform it as soon as possible, however, if it is close to the time of your next application, omit the missed application.

Do not use a double dose to compensate for missed 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 Aristo cream

Do not discontinue 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.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

• Mild burning or itching sensations after application
• Mild dryness or flaking of the skin
• Itching sensation

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

• Redness of the skin
• Skin eruption

Adverse effects that are very rare (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 eruption, itching, or urticaria
• Shortness of breath, difficulty breathing, or wheezing
• Unexplained fever and sensation of fainting, particularly when standing.

Contact your doctor immediately if you experience any of these symptoms. Stop using Aciclovir Aristo 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 that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, website:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not store at a temperature above25°C. Do not refrigerate. Store in the original packaging.

No use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

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, white light paraffin, cetostearyl alcohol emulsifying agent type A, methylparaben, propylparaben, purified water.

Appearance of the product and content of the packaging

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 packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid- Spain

Responsible for manufacturing:

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

Last review date of this leaflet: December 2023

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