VIRUDERM 50 mg/g OINTMENT

Introduction

Package Leaflet: Information for the User

Viruderm50 mg/g ointment

Aciclovir

Read all of this leaflet carefully before you start using this medicine,because it contains important information for you

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.

• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 10 days.

Contents of the package leaflet

1. What is Viruderm and what is it used for.
2. What you need to know before you start using Viruderm.
3. How to use Viruderm.
4. Possible side effects.
5. Storage of Viruderm.
6. Contents of the pack and further information

1. What is Viruderm and what is it used for

Viruderm is an ointment that contains the active ingredient aciclovir. Aciclovir belongs to a group of medicines called antivirals, active against the herpes simplex virus.

It is indicated for the local relief of symptoms caused by cold sores (fever blisters), such as: itching, burning or tingling in adults and adolescents from 12 years of age.

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

How does Viruderm work?

Cold sores or fever blisters appear due to an infection with a virus called herpes simplex.

Normally, a first infection occurs inside the mouth (usually in childhood) that may go unnoticed, but in the case of children, it must be diagnosed by a doctor to avoid confusing it with teething disorders or other oral conditions. After this first infection, the herpes simplex virus remains in the body without symptoms. The infection often presents with frequent new outbreaks, at other times in life, which usually appear as a consequence of sunburn, colds, fever, emotions, anxiety, mouth injuries, menstruation, dental or surgical interventions, or allergies to certain medications.

These outbreaks consist of a tingling or itching sensation on the lips followed by the appearance, after one or two days, of several small blisters that later evolve into an open sore on the lips, which finally transforms into a crust.

Until the crust appears, a sign that the lesion has healed, the blisters or sores are contagious.

2. What you need to know before you start using Viruderm

Do not use Viruderm

• If you are allergic to aciclovir or any of the other components of this medicine (listed in section 6).
• In children under 12 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Viruderm.

Immunocompromised patients (e.g., patients with AIDS, people who have received transplants, or who are undergoing radiotherapy or chemotherapy) should consult their doctor before using this medicine.

This medicine should only be used on the lips.

• Avoid contact of the ointment with the eyes, and if it occurs, wash thoroughly with water and consult a doctor.

Do not apply the product inside the mouth, nose, or vagina, as it would cause local irritation.

Do not use for the treatment of genital herpes.

To avoid contagion:

• Wash your hands after applying the product.
• Do not bring the lip lesion into contact with other areas of the body or with the skin of other people, especially infants and children. While the lesion lasts, try not to rub your lips against the bedding if you sleep with someone else, do not share towels, and use paper tissues and handkerchiefs to avoid reinfecting yourself.

If the lesion worsens or has not healed in 10 days, discontinue treatment and consult your doctor.

This medicine does not prevent subsequent outbreaks or reappearance of symptoms.

Other medicines and Viruderm

Tell your doctor or pharmacist if you are using, have recently used, or might use other medicines.

Although no interactions with this medicine have been described for this route of administration, other preparations should not be applied simultaneously to the area of the cold sore while this treatment lasts without consulting a doctor or pharmacist.

Pregnancy and breastfeeding

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

Taking medicines during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Driving and using machines

No effects on the ability to drive or use machines have been described.

3. How to use Viruderm

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor. In case of doubt, ask your doctor or pharmacist.

Use on the lips.

At the moment when the sensation of itching, tingling, or burning appears, before the appearance of the blisters, the virus is multiplying, and the treatment is most effective.

To avoid the risk of transmission of the virus, follow the instructions given in the "Warnings and precautions" section.

Start treatment as soon as symptoms of the process begin. The start of the cold sore can be easily recognized by the itching and tingling.

Apply 5 times a day, approximately every 4 hours, except during sleep hours. Apply a sufficient amount of product to cover the affected area of the lip 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, up to a total of 10 days.

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

Viruderm contains a specially formulated base and should not be diluted or used as a base for the incorporation of other medicines.

If you think the effect of Viruderm is too strong or too weak, tell your doctor or pharmacist.

Use in children

Do not administer this medicine to children under 12 years of age (see section "Do not use Viruderm").

If you use more Viruderm than you should

It is unlikely that poisoning will occur due to external use, but 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 medicine and the amount ingested.

If you forget to use Viruderm

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 duration of treatment.

If you stop using Viruderm

Do not stop treatment before your doctor advises, as your healing may not be complete and the disease may recur.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Transient burning or itching after applying Viruderm.
• Dryness or flaking of the skin or lips.
• Tingling sensation.

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

• Redness of the skin.
• Contact dermatitis (a type of local allergy) after application. Most of the time, the substances that cause it are components of the ointment other than aciclovir, which is the active ingredient.

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

• Immediate allergic reactions, including angioedema, which 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 medicine in ointment may lead to sensitivity phenomena; if they appear, treatment should be discontinued and a doctor consulted.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Viruderm

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

This medicine does not require special storage conditions.

Once opened and after completing the treatment, discard the tube.

Do not use this medicine after the expiry date stated on the packaging after EXP.

The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Viruderm

-The active ingredient of Viruderm is aciclovir. Each gram of ointment contains 50 milligrams of aciclovir.

-The other ingredients are: macrogol 4000 and macrogol 400.

Appearance of the product and pack contents

Viruderm is a homogeneous ointment of white color packaged in an aluminum tube with a plastic cap containing 2 g of ointment. The tube is packaged in a cardboard box.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of last revision of this leaflet:July 2020

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