Aciclovir Normon 50 mg/g cream EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Aciclovir NORMON 50 mg/g cream EFG

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. 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 pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Aciclovir NORMON 50 mg/g cream is and what it is used for
2. What you need to know before using Aciclovir NORMON 50 mg/g cream
3. How to use Aciclovir NORMON 50 mg/g cream
4. Possible side effects
5. How to store Aciclovir NORMON 50 mg/g cream
6. Contents of the pack and other information

1. What Aciclovir Normon 50 mg/g cream is and what it is used for

This medicinal product belongs to a group of medicines known as antivirals. It is indicated for the treatment of initial and recurrent genital herpes, herpes labialis, and localized mucocutaneous infections caused by the herpes simplex virus in immunocompetent patients (patients with a properly functioning immune system).

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

2. What you need to know before using Aciclovir Normon 50 mg/g cream

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 membranes of the mouth, eye, or vagina, as this may cause irritation. Take special care to avoid accidental introduction into the eye. If accidental contact with the eyes occurs, rinse thoroughly with water and consult an ophthalmologist if necessary.
• Do not exceed the recommended frequency of application or duration of treatment.
• Before starting treatment with this medicine, immunocompromised patients (e.g. patients with HIV infection (AIDS), organ transplant recipients, or those receiving radiotherapy or chemotherapy) must consult their doctor.
• Since cold sores are recurrences of an infection acquired earlier in life, usually during childhood, an initial medical diagnosis is essential, especially in children, in whom symptoms of the primary infection may go unnoticed or be mistaken for teething problems or other oral conditions.
• Avoid sexual contact in patients with genital herpes, as there is a risk of transmitting the infection to their partner. Aciclovir does not prevent transmission of herpes. The use of a condom may help prevent transmission. Do not exceed the recommended frequency of application or duration of treatment.
• In cases 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 carried out under medical supervision. Administration in adolescents aged 12 years and older is the same as for adults; see below.

Using Aciclovir NORMON 50 mg/g cream with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

No interactions with aciclovir related to this route of administration (topical) have been reported.

Pregnancy and breastfeeding

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

Pregnancy

There is insufficient information on the effects of cream application 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 in breast milk following topical administration.

Driving and using machines

The effect of this medicine on the ability to drive and use machines is none or negligible.

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.

3. How to use Aciclovir Normon 50 mg/g cream

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

The medicine should be administered as soon as possible after diagnosis, once signs or symptoms of the condition have appeared.

Remember to use your medicine.

Your doctor will indicate the duration of treatment with this medicine. Do not stop treatment early, as the viral infection may recur.

Adults and children over 12 years of age:

Apply five times a day, approximately every four hours, except during sleeping hours.

Apply a sufficient amount of the product to cover the affected area with a thin layer.

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

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

After applying this medicine, wash your hands to avoid spreading the lesion to other areas of the body or transmitting it to other people.

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

If you think that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you use more Aciclovir Normon 50 mg/g cream than you should

Cases of intoxication are unlikely 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 Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Aciclovir Normon 50 mg/g cream

Do not use a double dose to make up for missed doses; simply continue your regular treatment as soon as possible.

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

If you stop treatment with Aciclovir Normon 50 mg/g cream

Do not interrupt treatment before advised by your doctor, as healing may not be complete and your illness may reappear.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• Transient burning or itching after cutaneous application of aciclovir
• Mild dryness or skin peeling
• Itching sensation

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

• Skin redness
• Contact dermatitis (a type of local allergy) following application of the medicine. Sensitization tests have shown that the components of the cream, rather than aciclovir, are more frequently responsible for causing this reaction.

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

• Immediate hypersensitivity reactions including angioedema (inflammatory process affecting deep layers of the skin, manifested as swelling of the throat or difficulty swallowing or breathing). If this effect is severe, seek immediate medical attention, as emergency measures may be required.

Prolonged use of the cream may lead to sensitization phenomena; if these occur, treatment should be discontinued and a doctor consulted.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aciclovir Normon 50 mg/g cream

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

Store below 25°C.

Keep in the original packaging.

Do not use this medicine after the expiry date stated on the container following "Exp". The expiry date refers to the last day of the month indicated.

Period of validity after first opening of the tube: 1 month.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aciclovir NORMON 50 mg/g cream

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

The other components (excipients) are: cetostearyl alcohol, polyethylene glycol esters of fatty acids, decyl oleate, macrogol cetoestearil ether, phenylethyl alcohol, sodium citrate, citric acid and purified water.

Appearance of the medicine and contents of the pack

It is a white, shiny cream with an oily texture.

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

Only certain pack sizes may be available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Manufacturer:

ESPECIALIDADES FARMACÉUTICAS CENTRUM, S.A.
De A.S.AC. PHARMA.
C/. Sagitario, 14 - 03006 ALICANTE (SPAIN)

This leaflet was last approved in: February 2015

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

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address:

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