Label: information for the user

Aciclovir NORMON 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 to you, and you should not give it 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.

This medicine belongs to a group of medicines 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.

Do not use Aciclovir NORMON 50 mg/g cream

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Aciclovir NORMON 50 mg/g cream.

• Do not apply on the mucous membrane 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 medicine, immunodeficient 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 case of severe illness or frequent recurrences, your doctor should consider systemic treatment.

Children and adolescents

Application in children under 12 years should be carried out under medical supervision. Administration in children over 12 years is the same as for adults, see below.

Use of Aciclovir NORMON 50 mg/g cream with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine, 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 medicine.

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 machines

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

Aciclovir NORMON 50 mg/g cream contains cetyl alcohol

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

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 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 this medication is too strong or too weak, inform your doctor or pharmacist.

If you use more Aciclovir NORMON 50 mg/g cream 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 NORMON 50 mg/g cream

Do not use a double dose to compensate for the missed dose, 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 NORMON 50 mg/g cream

Do not discontinue treatment before the recommended duration 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 (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 a possible adverse effect not listed 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 a temperature below 25º C.

Store in the original packaging.

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.

Shelf life after the first opening of the tube: 1 month.

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

Composition of Aciclovir NORMON 50 mg/g cream

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

The other components (excipients) are: cetyl alcohol, polyethylene glycol fatty acid esters, decyl oleate, cetostearyl macrogol glyceride, phenyl ethyl alcohol, sodium citrate, citric acid, and purified water.

Appearance of the product and contents of the packaging

It consists of a white, shiny, and greasy cream to the touch.

It is available in tubes containing 2 g or 15 g, packaged in a cardboard box.

Only some packaging sizes may be available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Responsible for manufacturing

ESPECIALIDADES FARMACÉUTICAS CENTRUM, S.A.

De A.S.AC. PHARMA.

C/. Sagitario, 14 - 03006 ALICANTE (SPAIN)

This leaflet has been approved in February 2015

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

You can access detailed and updated information about this medicine by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/62127/P_62127.html