Leaflet: information for the user

Aciclovir pensa 50 mg/g cream EFG

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Aciclovir Pensa is and for what it is used

2. What you need to know before starting to take Aciclovir Pensa

3. How to take Aciclovir Pensa

4. Possible side effects

5. Storage of Aciclovir Pensa

6. Contents of the pack and additional information

This medication belongs to a group of medications called antivirals. It is indicated for the treatment of initial and recurrent genital herpes, cold sores, and localized mucocutaneous infections caused by the herpes simplex virus, in immunocompetent patients (with normal immune system function).

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

No use Aciclovir Pensa

- If you are allergic (hypersensitive) to aciclovir or to 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 on the mucous membrane of the mouth, eye, or vagina as it may cause irritation. Special care must be taken to avoid accidental introduction into the eye. If accidental contact with the eyes occurs, rinse with abundant water and consult an ophthalmologist if necessary.

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

- Before starting treatment with this medication, immunocompromised patients (for example, patients with HIV infection (AIDS), individuals who have received transplants, or those undergoing radiation or chemotherapy treatment), must consult their doctor.

- As herpes labial is a recurrence of an infection within the mouth that is usually contracted at an early age, a first medical diagnosis is necessary, especially in children, in whom the symptoms of this first infection may be overlooked or confused with dental disorders or other oral processes.

- Avoid sexual contact in patients with genital herpes as there is a risk of transmission of 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 frequency of applications or the duration of the recommended treatment.

- In case of severe illness or frequent recurrences, your doctor should consider systemic treatment.

Children and adolescents

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

Use of Aciclovir Pensa 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.

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

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

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

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible or insignificant.

Aciclovir Pensa contains cetoestearic alcohol and propylene glycol

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of 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 discontinue treatment before, as the infection caused by the virus may reappear.

Adults and children over 12 years:

Apply five times a day, approximately every four hours, excluding 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 5 more days to a total of 10 days.

You should consult a doctor if you worsen or do not improve after 10 days.

After applying this medication, wash your hands to prevent the spread of the lesion to other areas of the body or the transmission of the infection to others.

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

If you estimate that the action 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 you will experience symptoms of intoxication due to its external use, however, consult your doctor or pharmacist immediately.

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 Pensa

Do not use a double dose to compensate for the missed 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 discontinue treatment before the recommended duration, as your healing may not be complete and your disease may reappear.

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

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

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

- Transient burning or itching after topical application of aciclovir

- Mild dryness or peeling of the skin

- Itching sensation

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

- Skin redness

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

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

- Immediate hypersensitivity reactions including angioedema (inflammatory process of the deep skin layer that manifests with inflammation of the throat or difficulty swallowing or breathing). If this effect is very intense, seek medical attention as it requires emergency measures.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an 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:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

This medication does not require special storage conditions.Maintain this medication out of the 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 disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Aciclovir Pensa

- The active ingredient is aciclovir. Each gram of cream contains 50 mg of aciclovir.

- The other components are: propylene glycol, cetostearic alcohol emulsifier (Type B), liquid paraffin, petrolatum, poloxamer 407, and purified water.

Appearance of the product and content of the packaging

White or yellowish cream.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

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)

Last review date of this leaflet: May 2015

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