Lavirk 50 mg/g gel

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lavirk 50mg/g gel

Aciclovir

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

Follow exactly the instructions for use of this medicine as described 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 any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 10 days.

Contents of the leaflet

1. What Lavirk is and what it is used for

2. What you need to know before using Lavirk

3. How to use Lavirk

4. Possible adverse effects

5. How to store Lavirk

6. Contents of the pack and other information

1. What Lavirk is and what it is used for

Lavirk is a medicine 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 later stage (papule or vesicle).

To help you understand why you have cold sores and to ensure you use this medicine correctly, please read this leaflet carefully.

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

You should consult a doctor if you worsen or do not improve after 10 days.

2. What you need to know before using Lavirk

Do not use Lavirk:

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

Warnings and precautions

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

Use this medicine as soon as possible after the onset of infection; ideally, use it at the first signs of cold sore (such as tingling and itching).

Avoid touching your eyes. If you have any doubt about whether you have a cold sore, contact your doctor.

This medicine is not recommended for use in individuals with severe immunodeficiency (e.g., patients with AIDS or individuals who have received a bone marrow transplant). In such cases, oral aciclovir treatment may be considered. Such individuals are encouraged to consult a doctor regarding treatment for any infection.

Other medicines and Lavirk

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

Pregnancy, lactation and fertility

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

Lavirk contains propylene glycol (E-1520)

This medicine contains 300 mg of propylene glycol in each gram of gel.

Propylene glycol may cause skin irritation.

3. How to use Lavirk

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The amount of gel contained in this package is sufficient for one outbreak of cold sores. It is important to start treatment immediately after the first symptoms of cold sores appear. Many patients recognize when a cold sore is about to develop due to sensations of burning, itching, and tingling. It is recommended to apply this medicine as early as possible, for example, during the tingling phase. Treatment may also be started during the blister phase.

Follow the instructions carefully.

Adults and children over 12 years of age

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

Apply to the affected area 5 times daily at intervals of approximately four hours, without applying it at night. If you forget a dose, apply it as soon as you remember and continue as before.

Continue treatment for 4 days (4 x 5). If your cold sore has not healed by then, you may use the gel for an additional 6 days. If your cold sore has not completely healed after 10 days, or if it worsens, consult your doctor.

Do not use more than the recommended dose.

Use in children

Children between 2 and 12 years of age: consult your pharmacist or doctor.

Wash your hands before and after applying this medicine to prevent transfer or worsening of the infection.

If you use more Lavirk than you should

If you use too much Lavirk, speak to your doctor or pharmacist, inform them and take the container with you.

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

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

If you forget to use Lavirk

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

If in doubt, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Usually, patients tolerate this medicine well; however, some people might experience adverse effects. A burning or stinging sensation may occur after application. These effects will disappear quickly.

Sometimes, the patient's skin may be affected by redness, itching, mild dryness or peeling, skin rashes, hives, or eruptions.

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

Reporting of adverse reactions

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

5. Lavirk Storage

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

Check the expiry date before starting treatment.

Do not use this medicine after the expiry date stated on the packaging and on the tube after "EXP". The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice that the packaging shows signs of damage.

Medicines must not be disposed of via wastewater or household waste. Instead, dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

Reminder

Cold sores are contagious.

The virus can infect other parts of the body. To reduce the risk of spreading the infection, do not allow others to touch your cold sore, and do not share your towel, etc.

Avoid kissing and oral sex if you or your partner have an active cold sore. Always wash your hands before and after touching the cold sore.

Avoid touching your eyes. Herpes simplex infection of the eye can cause corneal ulcers. Avoid kissing, especially children, if you have a cold sore.

Do not break the blisters or touch the scabs. Not only could you infect the cold sore with other germs, but you might also spread the virus to your fingers.

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

Patient Information

A cold sore is an infection caused by the herpes simplex virus (HSV), which remains inactive (in a latent state) in the nerve ganglia of the face.

When does the first infection occur?

The first infection usually occurs in early childhood, likely after being kissed by a person with the infection. The virus enters through the skin, travels to a nerve, and remains indefinitely in a nerve junction. Typically, no cold sore outbreak occurs upon first exposure.

What can trigger the virus?

Several factors can trigger the virus, such as colds, flu, menstruation, fatigue, emotional distress, stress, physical injuries, strong sunlight, and changes in weather. Once activated, the virus travels from the nerve to the skin and around the lips, where it causes cold sores.

6. Contents of the container and additional information

Composition of Lavirk

• The active substance is aciclovir. Each gram of gel contains 50 mg of aciclovir.
• The other components (excipients) are carbopol, 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 2 g aluminium tube, a 5 g pump dispenser, and a 15 g aluminium tube.

Only certain 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)

Álava Technology Park

C/ Leonardo Da Vinci 11

01510 Miñano, Álava

Spain

This medicinal product is authorized in the European Economic Area Member States under the following names:

Spain: Lavirk 50 mg/g gel

Portugal: Lipovir 50 mg/g Gel

Date of the most recent review of this leaflet: July 2020.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.