Lipovir 50 mg/g Gel is a medicine for the treatment of symptoms (such as tingling, burning, discomfort) of recurrent cold sores, which is caused by the herpes simplex virus.
Clinical studies with acyclovir cream have shown statistically significant efficacy in healing lesions and reducing pain compared to a placebo cream:
• Healing time was up to 22% faster (mean duration was reduced by up to 0.5 days)
• Pain disappeared about 20% faster (mean duration was reduced by up to 0.4 days)
• Approximately 60% of patients started treatment early (prodroma or erythema) and 40% at a later stage (papule or blister).

To help you understand why you have herpes labialis and to make sure that you use Lipovir 50 mg/g Gel correctly, please read this insert carefully. Keep it because you may want to read it again.
- If you do not feel better or get worse after 10 days, speak to a doctor.

Do not use Lipovir 50 mg/g Gel:
• If you are allergic (hypersensitive) to acyclovir, valacyclovir, propylene glycol or any of the other ingredients of this medicine (listed in section 6). - For Herpes simplex infections in the eye, genital area or other areas;
• If you have problems with your immune system that may make you more prone to infections;
• Do not apply the gel inside the mouth (e.g. for mouth ulcers) or nose.

WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Lipovir 50 mg/g Gel.
Use Lipovir 50 mg/g Gel as soon as possible after the infection starts, preferably when the first signs appear (such as tingling and itching). Use only for herpes simplex lesions on the lips and face.
Avoid any contact with the eyes. Talk to your doctor if you are unsure that your lesion is herpes labialis. You should talk to your doctor if your labial herpes lesions are or become very serious.

Lipovir 50 mg/g Gel is not recommended for severely immunocompromised patients (e.g. patients with AIDS or undergoing a bone marrow transplant) for whom oral treatment with acyclovir should be considered. These patients should be advised to talk to a doctor for treatment of any infection.

Other medicines and Lipovir 50 mg/g Gel
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Lipovir 50 mg/g Gel is unlikely to interact significantly with other medicines that you are taking.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to get pregnant, ask your doctor or pharmacist for advice before using this medicine.

Lipovir 50 mg/g Gel contains propylene glycol (E1520)
It may cause skin irritation.

Use the medicine exactly as described in this insert or as instructed by your doctor or pharmacist. If you are unsure, talk to your doctor or pharmacist.

The amount of gel in the pack is sufficient for one episode of herpes labialis. It is important to start treatment immediately after the first herpes labialis symptoms appear. Many people with herpes labialis can anticipate when they are about to have herpes labialis, i.e. they feel a prick, itch, or tingling. Lipovir 50 mg/g Gel should be applied as soon as possible, e.g. in the tingling phase. However, herpes labialis may start as early as the blister stage.

If you use more Lipovir 50 mg/g Gel than you should
If you use more Lipovir 50 mg/g Gel than recommended, you should seek advice from your doctor or pharmacist and take this pack with you.
Accidental ingestion of Lipovir 50 mg/g Gel is unlikely to cause any serious problems. However, if this happens you should tell your doctor or pharmacist.

If you forget to use Lipovir 50 mg/g Gel
If you forget to apply the gel as recommended, do not worry. Apply it as soon as you remember and then continue as before.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
This medicine is usually well tolerated by patients. However, some people may experience the following side effects:

• A burning or prickly sensation may occur soon after application, but it will go away quickly.
• Redness, itching, a slight dryness or scaling of the skin may occur occasionally.
• On a rare occasion, an allergic skin reaction may develop, and even more rarely this reaction will be severe, such as facial swelling (swelling of the lips, face and eyelids). In this case, stop using the medicine and talk to your doctor immediately.

Reporting side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this insert. You can also report side effects directly to INFARMED, I.P. using the contact details below. By reporting side effects, you are helping to provide more information on the safety of this medicine.

INFARMED, I.P.
Medicine Risk Management Directorate
Parque da Saúde de Lisboa, Av. Brasil 53
1749-004 Lisbon
Tel: +351 21 798 73 73
Medicine Helpline: 800222444 (freephone) Fax: + 351 21 798 73 97
Website: http://www.infarmed.pt/web/infarmed/submissaoram
E-mail: farmacovigilancia@infarmed.pt

Remember
Herpes labialis is contagious.
The virus can infect other parts of your body. To reduce the risk of passing on the infection to others, do not allow them to touch your lesions, share your towel, etc. You should avoid kissing and having oral sex if you or your partner have a herpes labialis lesion. Always wash your hands before and after touching your herpes labialis lesions.
Avoid touching your eyes. Herpes simplex infection of the eye can cause corneal ulcers.
Avoid kissing - especially children - when you have herpes labialis.
Avoid bursting or squeezing the lesions or tearing off the crusts because you may infect the lesions with other germs, as well as infecting your fingers with the virus. Avoid sharing your personal items (cutlery, glasses, etc.).

Patient information
Herpes labialis is an infection that is caused by the Herpes simplex virus (HSV) that is dormant (latent) in the facial nerve ganglia.

When does the first infection occur?
First contact with the virus usually occurs in childhood, probably after being kissed by an infected person. The virus passes through the skin and travels into the nerve tissue where it remains until it is activated. This first contact does not usually lead to any episode of herpes labialis.

What can activate the Virus?
Several factors can activate the virus, including colds, flu, menstruation, fatigue, emotional disturbances, stress, physical injury, intense sunlight, or weather changes. Once activated, the virus travels from the nerve to the skin of the lips and the surrounding area, where it causes the development of herpes labialis lesions.

What Lipovir 50 mg/g Gel contains
The active substance is acyclovir. Each gram of gel contains 50 mg of acyclovir.
The other ingredients (excipients) are polycarbophil, povidone 30, menthol, trometamol, glycerol, propylene glycol (E1520) and purified water.

What Lipovir 50 mg/g Gel looks like and contents of the pack
Lipovir 50 mg/g Gel is a white to yellowish gel that forms a clear film after application.
Lipovir 50 mg/g Gel is available in a 2g aluminium tube, 5g plastic dosing device and 15g aluminium tube.

Marketing Authorisation Holder
Laboratorios Ojer Pharma, S.L.
C/ Sancho el Mayor 2, 1º izquierda
31002 Pamplona, Navarra
Spain

Manufacturer
Laboratorium Sanitatis, S.L. (Fab. Alava)
C/ Leonardo da Vinci, 11 - Parque Tecnológico de Alava
Miñano 01510 Alava
Spain

Detailed and up-to-date information on this medicine is available by scanning the 2D code included on the pack with a smartphone. The same information is also available at the following URL: https://www.tolifeotc.com/lipovir.

This insert was last revised in February 2024.