ACICLOVIR NORMON 50 mg/g CREAM

Introduction

Leaflet: Information for the user

Aciclovir NORMON 50 mg/g cream EFG

Read the entire leaflet carefully before starting to use this medication, as 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 medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Aciclovir NORMON 50 mg/g cream and what is it used for
2. What you need to know before starting to use Aciclovir NORMON 50 mg/g cream
3. How to use Aciclovir NORMON 50 mg/g cream
4. Possible side effects
5. Storage of Aciclovir NORMON 50 mg/g cream
6. Package contents and additional information

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

This medication belongs to the 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 a properly functioning immune system).

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

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

Do not use Aciclovir NORMON 50 mg/g cream

• 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 NORMON 50 mg/g cream.

• Do not apply to the mucous membranes of the mouth, eye, or vagina, as it may cause irritation. Be 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 treatment duration.
• Before starting treatment with this medication, immunodeficient patients (e.g., patients with HIV/AIDS, those who have received transplants, or those undergoing radiotherapy or chemotherapy) should consult their doctor.
• Since cold sores are a recurrence of an infection inside the mouth that is usually contracted at an early age, a medical diagnosis is necessary, especially in children, in whom the symptoms of this first infection may go unnoticed or be confused with teething disorders or other oral conditions.
• Avoid sexual contact in patients with genital herpes, as there is a risk of transmitting 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 treatment duration.
• In case 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 done under medical supervision. Administration in children over 12 years of age is the same as for adults, see below.

Using Aciclovir NORMON 50 mg/g cream with other medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those purchased without a prescription.

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

Pregnancy and breastfeeding

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

Pregnancy

There is not enough 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

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

Driving and using machines

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

Aciclovir NORMON 50 mg/g cream contains cetyl alcohol

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

The medication will be administered as soon as possible after diagnosis, once symptoms or signs of the process appear.

Remember to use your medication.

Your doctor will indicate the duration of treatment with this medication. Do not stop treatment before it is advised by your doctor, as your cure may not be complete and your disease may recur.

Adults and children over 12 years of age:

Apply five times a day, approximately every four hours, except during 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 after 5 days, treatment may be extended for an additional 5 days, up to a total of 10 days.

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

After applying this medication, wash your hands to avoid spreading the lesion to other areas of the body or transmitting it 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 think the effect 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 overdose symptoms will occur due to 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, phone 91 562 04 20, indicating the medication 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 forgotten 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 NORMON 50 mg/g cream

Do not interrupt treatment before your doctor advises, as your cure may not be complete and your disease may recur.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

• Transient burning or itching after applying aciclovir to the skin
• Mild dryness or peeling of the skin
• Itching sensation

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

• Redness of the skin
• Contact dermatitis (a type of local allergy) after applying the medication. When sensitivity tests have been performed, it has been shown that the components of the cream, rather than aciclovir, are more likely to cause it.

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

• Immediate hypersensitivity reactions, including angioedema (an inflammatory process of the deep skin that manifests with throat inflammation or difficulty swallowing or breathing). If this effect is very intense, you should go to a medical center, as it requires emergency measures.

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for human use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Aciclovir Normon 50 mg/g cream

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

Store at a temperature below 25°C.

Keep in the original packaging.

Do not use this medication after the expiration date shown on the packaging after "Cad". The expiration date is the last day of the month indicated.

Validity period after opening the tube: 1 month.

Medications should not be thrown away through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

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 esters of fatty acids, decyl oleate, macrogol ketoester, phenylethyl alcohol, sodium citrate, citric acid, and purified water.

Appearance of the product and package contents

It consists of a white, shiny, greasy cream.

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

Only some package sizes may be available.

Marketing authorization holder and manufacturer

Marketing authorization 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 approved inFebruary 2015

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

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