Viruderm 50 mg/g pomada

Leaflet: information for the user

Viruderm50 mg/g cream

Aciclovir

Read this leaflet carefully before you start using thismedicine, because it contains important informationfor you

Follow exactly the administration instructions for the medicine contained in this leaflet or those 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.
• Ifyou experience any side effects, consult your doctor or pharmacist,even if they do not appear in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improveafter 10 days.

1. What Viruderm is and what it is used for.

2. What you need to know before starting to use Viruderm.

3. How to use Viruderm.

4. Possible side effects.

5. Storage of Viruderm.

6. Contents of the pack and additional information

Viruderm is a cream 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 herpes labialis (fever blisters), such as: itching, burning or tingling in adults and adolescents from 12 years old.

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

How does Viruderm work?

Fever blisters or herpes labialis appear due to an infection caused by a virus called herpes simplex.

Normally, the first infection occurs within the mouth (usually in childhood) and may go unnoticed, but in the case of children, it should be diagnosed by a doctor to avoid confusing it with dental problems or other oral processes. After this first infection, the herpes simplex virus remains in the body without presenting symptoms. The infection often presents new outbreaks at other times in life, which usually appear as a result of sunburn, colds, fever, emotions, anxiety, mouth injuries, menstruation, dental or surgical interventions, or allergies to some medications.

These outbreaks consist of a tingling or itching sensation on the lips followed by the appearance, within one or two days, of several small blisters that then evolve into open sores on the lips, which finally transform into a scab.

Until the scab appears, indicating that the lesion has healed, the blisters or sores are contagious.

Do not use Viruderm

- If you are allergic to aciclovir or any of the other components of this medication (listed in section 6).

- In children under 12 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Viruderm.

Immunocompromised patients (e.g. patients with AIDS, individuals who have received transplants, or those undergoing radiation or chemotherapy treatment), should consult their doctor before using this medication.

This medication should only be used for cold sores on the lips.

- Avoid contact of the ointment with the eyes, and in case of contact, wash abundantly with water and consult your doctor.

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

Do not use for the treatment of genital herpes.

To avoid contagion:

• Wash your hands after applying the product.
• Do not put the lip lesion in contact with other areas of the body or with the skin of other people, especially infants and children. While the lesion persists, try not to rub the bedding with your lips if you sleep with another person, do not share towels, and use paper towels and paper tissues to avoid re-infecting yourself.

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

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

Other medications and Viruderm

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

Although no interactions of this medication have been described by this route of administration, do not apply other preparations in the area of the cold sore while this treatment is ongoing without consulting your doctor or pharmacist.

Pregnancy and breastfeeding

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

The consumption of medications during pregnancy can be hazardous to the embryo or fetus, and should be monitored by your doctor.

Driving and operating machinery

No effects on the ability to drive or operate machinery have been described.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor. In case of doubt, ask your doctor or pharmacist.

Lip herpes treatment.

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

To avoid the risk of virus transmission, follow the indications given in the section “Warnings and precautions”.

You should start treatment as soon as the symptoms of the process begin. The onset of fever can be easily recognized by itching and itching.

Apply 5 times a day, approximately every 4 hours except during sleep hours. Apply with your finger 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 medication, wash your hands to avoid the spread of the lesion to other areas of the body or the transmission of the virus to others.

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

If you estimate that the action of Viruderm is too strong or too weak, inform your doctor or pharmacist.

Use in children

Do not administer this medication 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 you will experience symptoms of intoxication 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 useViruderm

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 the treatment with Viruderm

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications,this medicationcan produce adverse effects, although not all people will experience them.

Infrequent (may affect up to 1 in 100 patients):

• Mild burning or itching sensations after applying Viruderm.
• Dryness or peeling of the skin or lips
• Sensation of itching.

Rare (may affect up to 1 in 1,000 patients)

• 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 cream other than aciclovir, which is the active ingredient.

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

• Immediate allergic reactions, including angioedema, which manifests as 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, the 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 Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

This medication does not require special storage conditions.

Once opened and treatment completed, discard the tube.

Do not usethis medicationafter the expiration date appearing on the packaging after CAD.

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

Medications should not be disposed of through drains or trash. Deposit packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofViruderm

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

-The othercomponents are: macrogol 4000 and macrogol 400.

Appearance of the product and contents of the packaging

Viruderm is a homogeneous, off-white ointment packaged in an aluminum tubeequipped with a plastic cap containing2 gof ointment. The tube is packaged in a cardboard box.

Holder of the marketing authorization and responsible for manufacturing

Cinfa Laboratories, S.A.

Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Date of the last review of this leaflet:July 2020

The detailed information on this medicine is available on the website ofthe Spanish Agencyof Medicines and Medical Devices (AEMPS)www.aemps.gob.es