LAVIRK 50 mg/g GEL

Introduction

Package Leaflet: Information for the User

Lavirk 50mg/g gel

Aciclovir

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

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

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult a pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package 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 Lavirk and what is it used for
2. What you need to know before starting to use Lavirk
3. How to use Lavirk
4. Possible side effects

1. Storage of Lavirk
2. Contents of the pack and further information

1. What is Lavirk and what is it used for

Lavirk is a medication used to treat the symptoms (such as tingling, burning, and discomfort) of recurrent herpes labialis caused by the herpes simplex virus.

Clinical trials, conducted in comparison with a placebo cream, demonstrate a statistically significant efficacy of aciclovir cream in reducing healing time and duration of pain:

• Healing time was up to 22% faster (mean duration reduced by 0.5 days)
• Pain disappeared approximately 20% faster (mean duration reduced by 0.4 days)

Approximately 60% of patients started treatment at an early stage (prodrome or erythema) and 40% at a late stage (papule or vesicle).

To help you understand why you have herpes labialis and ensure you use this medication correctly, we ask that you read this package leaflet carefully.

Keep this package leaflet; you may need to read it again.

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 Lavirk

Do not use Lavirk:

• If you are allergic (hypersensitive) to aciclovir, valaciclovir, propylene glycol, or any of the other components of this medication (listed in section 6).
• For herpes simplex infections in the eyes and genital area or other types.
• If you have immune system problems that may make you more prone to infections.
• Do not use it inside the mouth (e.g., for mouth ulcers) or nose.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use this medication.

Use this medication as soon as possible after the onset of infection; ideally, use it when the first symptoms of herpes labialis appear (such as tingling and itching).

Avoid touching your eyes. If you are unsure whether you have herpes labialis, contact your doctor.

This medication is not recommended for people with severe immune system impairment (e.g., patients with AIDS or those who have received a bone marrow transplant). In such cases, treatment with oral aciclovir may be considered. Such individuals are encouraged to consult a doctor about the treatment of any infection.

Other Medications and Lavirk

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

In principle, this medication does not affect any other medication you may be using.

Pregnancy, Breastfeeding, and Fertility

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

Lavirk contains propylene glycol (E-1520)

This medication contains 300 mg of propylene glycol per gram of gel.

Propylene glycol may cause skin irritation.

3. How to Use Lavirk

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The amount of gel in this package is sufficient for one episode of herpes labialis. It is essential to start treatment immediately after the first symptoms of herpes labialis appear. Many patients notice when they are about to have an episode due to the sensation of burning, itching, and tingling. This medication should be applied as soon as possible, for example, during the tingling phase. Treatment can also be started during the blister phase.

S

Adults and Children Over 12 Years

Apply the gel with your finger to completely cover the affected area, including the outer edges of the vesicles.

Apply it to the affected area 5 times a day at approximately 4-hour intervals, without applying it at night. If you forget a dose, apply it when you remember and continue as before.

Continue treatment for 4 days (4 x 5). If your herpes labialis has not healed after this time, you can use the gel for an additional 6 days. If your herpes labialis has not healed completely after 10 days or worsens, consult your doctor.

Do not use more than the recommended dose.

U

Children Between 2 and 12 Years: Consult your pharmacist or doctor.

Wash your hands before and after applying this medication to avoid transferring or worsening the infection.

Safety Precautions

Talk to your doctor or pharmacist if you use too much Lavirk, inform them, and take the package with you.

If you accidentally swallow some gel, it is unlikely to have any side effects; however, you should inform your doctor or pharmacist.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone: 91 562 04 20, consult your doctor or pharmacist.

Safety

If you forget to apply a dose of this medication, do not worry and apply it as soon as you remember. Then, continue as before.

In case of doubt, consult your doctor or pharmacist.

4. Possible Side Effects

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

Normally, patients tolerate this medication well; however, some people may experience side effects. Burning or stinging may occur after application. These effects will disappear quickly.

Occasionally, the patient's skin may be affected by mild redness, itching, dryness, or flaking, skin rashes, hives, or wheals.

Rarely, allergic reactions such as swelling of the lips, face, and eyelids may occur. In this case, stop using the medication and inform your doctor.

C

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Lavirk

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

Check the expiration date before starting treatment.

Do not use this medication after the expiration date shown on the package and tube after "EXP". The expiration date is the last day of the month indicated.

Do not use this medication if you notice that the package shows signs of deterioration.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

R

Herpes labialis is contagious.

The virus can infect other parts of the body. To reduce the risk of transmitting the infection, do not let others touch your herpes labialis, do not share your towel, etc.

You should avoid kissing and oral sex if you or your partner has active herpes labialis. Always wash your hands before and after touching herpes labialis.

Avoid touching your eyes. Herpes simplex eye infection can cause corneal ulcers. Avoid kissing, especially children, if you have herpes labialis.

Do not burst the blisters or touch the scabs. You may not only infect herpes labialis with other germs, but you can also infect your fingers with the virus.

Do not share your eating and drinking utensils (cutlery, glasses, etc.).

I

Herpes labialis is an infection caused by the herpes simplex virus (HSV), which is dormant (latent) in the nerve ganglia of the face.

W

The first infection usually occurs in early childhood, probably after being kissed by a person with the infection. The virus passes through the skin, travels to a nerve, and remains in a nerve junction indefinitely. Normally, no episode of herpes labialis occurs with the first contact.

W

There are several factors that can activate the virus, such as colds, flu, menstruation, fatigue, emotional upset, stress, physical injury, strong sunlight, and climate changes. Once activated, the virus travels from the nerve to the skin and around the lips, causing herpes labialis.

6. Contents of the Pack and Further Information

Composition of Lavirk

• The active ingredient is aciclovir. Each gram of gel contains 50 mg of aciclovir.
• The other ingredients (excipients) are polycarbophil, PVP 30, menthol crystals, tromethamine, glycerin, propylene glycol, and purified water.

Appearance of Lavirk and Contents of the Pack

Lavirk is a soft, white to yellowish gel that forms a transparent film after application.

Lavirk is available in a 2g aluminum tube, a 5g pump dispenser, and a 15g aluminum tube.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

LABORATORIUM SANITATIS, SL (LABSAN)

Parque Tecnológico de Álava

C/ Leonardo Da Vinci 11

01510 Miñano, Álava

Spain

This Medication is Authorized in the Member States of the European Economic Area Under the Following Names:

Spain: Lavirk 50 mg/g gel

Portugal: Lipovir 50 mg/g Gel

Date of the Last Revision of this Package Leaflet: July 2020.

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