ACICLOVIR PENSA 50 mg/g CREAM

2. What you need to know before using Aciclovir Pensa

Do not use Aciclovir Pensa

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Aciclovir Pensa.

• Do not apply to the mouth, eye, or vaginal mucosa, as it may cause irritation. Special care should be taken to avoid accidental introduction into the eye. If accidental contact with the eyes occurs, wash with plenty of water and consult an ophthalmologist if necessary.
• Do not exceed the recommended frequency of applications or treatment duration.
• Before starting treatment with this medication, immunodeficient patients (e.g., patients with HIV/AIDS, those who have received transplants, or those undergoing radiotherapy or chemotherapy) should consult their doctor.
• Since cold sores are a recurrence of an infection inside the mouth that is usually contracted at an early age, a medical diagnosis should be made, especially in children, in whom the symptoms of this first infection may go unnoticed or be confused with dental disorders or other oral conditions.
• Avoid sexual contact in patients with genital herpes, as there is a risk of transmitting the infection to the partner. Aciclovir does not prevent the transmission of herpes. The use of a condom may prevent it. Do not exceed the recommended frequency of applications or treatment duration.

• In case of severe disease or frequent recurrences, your doctor should consider systemic treatment.

Children and adolescents

Application in children under 12 years of age should always be done under medical supervision. Administration in children over 12 years of age is the same as for adults, see below.

Using Aciclovir Pensa 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 purchased without a prescription.

No interactions with aciclovir associated with this route of administration (topical) have been described.

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

There is not enough information on the effects of administering the cream during pregnancy. Systemic administration of aciclovir to rats and rabbits has not produced teratogenic or embryotoxic effects.

Breastfeeding

There is no information available on the levels of aciclovir that appear in breast milk after topical administration.

Driving and using machines

The influence of this medication on the ability to drive and use machines is nil or insignificant.

Aciclovir Pensa contains cetyl alcohol and propylene glycol

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

This medication may cause skin irritation because it contains propylene glycol.

3. How to use Aciclovir Pensa

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The medication will be administered as soon as possible, once the diagnosis has been made, after the appearance of signs or symptoms of the process.

Remember to use your medication.

Your doctor will indicate the duration of treatment with this medication. Do not stop treatment before it is completed, as the infection caused by the virus may recur.

Adults and children over 12 years of age:

Apply five times a day, approximately every four hours, except during sleep hours. Apply a sufficient amount of product to cover the affected area with a thin layer.

Continue treatment for 5 days. If complete healing has not occurred in 5 days, treatment may be extended for another 5 days, up to a total of 10 days.

You should consult a doctor if it worsens or does not improve after 10 days.

After applying this medication, wash your hands to avoid spreading the lesion to other areas of the body or infecting others.

This medication contains a specially formulated base and should not be diluted or used as a base for incorporating other medications.

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

If you use more Aciclovir Pensa than you should

It is unlikely that poisoning will occur due to external use, but consult your doctor or pharmacist immediately.

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 Pensa

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 frequency of applications or treatment duration.

If you interrupt treatment with Aciclovir Pensa

Do not interrupt treatment before your doctor advises, as your healing may not be complete and your disease may recur.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Uncommon (may affect up to 1 in 100 people):

• Transient burning or itching after topical application of aciclovir
• Mild dryness or flaking of the skin
• Itching sensation

Rare (may affect up to 1 in 1,000 people):

• Redness of the skin
• Contact dermatitis (a type of local allergy) after application of the medication. When sensitivity tests have been performed, it has been shown that the substances that cause it are more frequently components of the cream rather than aciclovir

Very rare (may affect up to 1 in 10,000 people):

• Immediate hypersensitivity reactions, including angioedema (an inflammatory process of the deep skin that manifests with throat inflammation or difficulty swallowing or breathing). If this effect is very intense, you should go to a medical center as it requires emergency measures.

Prolonged use of the medication in cream may lead to sensitivity phenomena; if they appear, treatment should be discontinued and a doctor consulted.

Reporting side effects

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

5. Storage of Aciclovir Pensa

This medication does not require special storage conditions. Keep this medication out of sight and reach of children.

Do not 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 thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Aciclovir Pensa

• The active ingredient is aciclovir. Each gram of cream contains 50 mg of aciclovir.
• The other components are: propylene glycol, cetyl alcohol emulsifier (Type B), liquid paraffin, petrolatum, poloxamer 407, and purified water.

Appearance of the product and package contents

White or yellowish cream.

It is presented in cardboard boxes containing tubes with 2 and 15 grams of cream packaged in aluminum tubes.

Marketing authorization holder and manufacturer

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Towa Pharmaceutical Europe, S.L.

C/ de Sant Martí 75-97

08107 Martorelles (Barcelona)

Spain

or

Kern Pharma, S.L.

Polígon Industrial Colón II, Venus, 72

08228 Terrassa – Barcelona (Spain)

Date of the last revision of this leaflet: May 2015

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