Label: Information for the User

Aciclovir Kern Pharma 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 read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who 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.

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 Kern Pharma

• 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 this medication.

• 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, wash with abundant 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, immunocompromised patients (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 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 problems 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 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 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 Kern Pharma 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 associated with this route of administration (topical) have been described.

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 Kern Pharma contains cetoestearic alcohol and propylene glycol

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

This medication contains 393 mg of propylene glycol (E-1520) per gram of product.

Propylene glycol may cause skin irritation.

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 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.

Aciclovir Kern Pharma 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 Kern Pharma is too strong or too weak, inform your doctor or pharmacist.

If you use more Aciclovir Kern Pharma than you should

It is unlikely that you will experience symptoms of overdose 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 Kern Pharma

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 Kern Pharma

Do 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 everyone 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 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 (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.

Keep 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.

No special storage conditions are required.

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 point at 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 Kern Pharma

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

• The other components are: poloxamer 407, cetostearyl alcohol emulsifying agent (type B), white vaseline, liquid paraffin, propylene glycol (E-1520) 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 g of cream.

Only some sizes of packaging may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: January 2015

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