PATIENT INFORMATION LEAFLET

Aciclovir MABO 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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 MABO is and what it is used for

2. What you need to know before using Aciclovir MABO

3. How to use Aciclovir MABO

4. Possible side effects

5. Storage of Aciclovir MABO

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 proper functioning of the immune system).

Consult a doctor if it worsens or does not improve after 10 days.

No use Aciclovir MABO

• 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 MABO:

• Do not apply to the mucous membranes of the mouth, eye, or vagina as it may cause irritation. Be especially careful to avoid accidental introduction into the eye. If accidental contact with the eyes occurs, rinse with plenty of water and consult an ophthalmologist if necessary.
• Do not exceed the recommended frequency of applications or duration of treatment.
• Before starting treatment with this medication, patients with immunodeficiency (e.g. 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 usually occurs 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 problems or other oral processes.
• Avoid sexual contact in patients with genital herpes as there is a risk of transmitting the infection to their partner. Aciclovir does not prevent the transmission of herpes. Using a condom may prevent it. Do not exceed the recommended frequency of applications or duration of treatment.
• In cases of severe illness or frequent recurrences, your doctor should consider systemic treatment.

Children and adolescents

Application in children under 12 years old should always be done under medical supervision.

Administration in children over 12 years old is the same as for adults, see below.

Use of Aciclovir MABO 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.

Pregnancy and breastfeeding

If you are pregnant, 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 administering 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 or operate machinery is negligible or insignificant.

Aciclovir Mabo contains cetomacrogol

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

Follow exactly the administration instructions for this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The medication should 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 beforehand, as the infection caused by the virus may reappear.

Adults and children over 12 years old

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 to incorporate other medications.

If you estimate that the action of Aciclovir MABO is too strong or too weak, inform your doctor or pharmacist.

If you use more Aciclovir Mabo 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 Mabo

Do not use a double dose to compensate for the missed doses, simply continue with the usual treatment as soon as possible.

You should not exceed the recommended frequency of applications or treatment duration.

If you interrupt treatment with Aciclovir MABO

You should not discontinue treatment before the recommended time by your doctor, as your healing may not be complete and your disease may reappear.

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

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

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

Uncommon (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 skin sensitivity 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 (a deep skin inflammation process that manifests with throat inflammation or difficulty swallowing or breathing). If this effect is very intense, seek medical attention immediately.

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 they are adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medications for Human Use:www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Store at room temperature.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications.This will help protect the environment.

Composition of Aciclovir MABO

• The active ingredient is aciclovir. Each gram of cream contains 50 mg of aciclovir.
• The other components are polyethylene glycol esters of fatty acids, decyl oleate, cetostearyl macrogol ether, cetyl alcohol, phenylethyl alcohol, sodium citrate (E-331), citric acid, and purified water.

Appearance of the product and contents of the packaging

The cream is a uniform, white, bubble-free cream.

It is presented in aluminum tubes of 2 and 15 g, packaged in a cardboard box.

Holder of the authorization

MABO-FARMA

Calle Rejas 2, 1st floor

28821 Coslada, Madrid(Spain).

Responsible for manufacturing

LISAPHARMA, S.P.A

Via Licinio, 11

I-22036 Erba (Como), Italy

or

LABORATORIOS BOHM, S.A.

C/ Molinaseca, 23. Industrial Estate Cobo Calleja,

Fuenlabrada, 28947 Madrid

Spain

This leaflet was approved in April 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/