NOTICE
ANSM - Updated on : 27/11/2023
Product name
VIRPAX 50 mg, muco-adhesive buccogingival tablet
acyclovir
Box
Please read this leaflet carefully before using this medicine, as it contains important information for you.
You must always use this medicine in strict accordance with the information given in this leaflet or by your doctor, pharmacist or nurse.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after 5 days.
What does this leaflet contain?
1. What is VIRPAX 50 mg, muco-adhesive buccogingival tablet and what is it used for?
2. What do I need to know before using VIRPAX 50 mg, buccogingival mucoadhesive tablet?
3. How do I use VIRPAX 50 mg, buccogingival mucoadhesive tablet?
4. What are the possible side effects?
5. How to store VIRPAX 50 mg, buccogingival mucoadhesive tablet?
6. Package contents and other information.
1. WHAT IS VIRPAX 50 mg, buccogingival mucoadhesive tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code: Anti-viral for local treatment - J05AB01.
Virpax contains the active substance aciclovir and belongs to a group of medicines known as antivirals.
Virpax is used to treat recurrent cold sores caused by the herpes simplex virus in adults with a functioning immune system. Virpax should be applied directly to the gums as soon as the first symptoms (burning, tingling, itching) or signs (redness, swelling) appear.
The virus causes vesicles or inflammation mainly on the lips, but sometimes also on other parts of the face. This viral infection can be activated when the immune system is weakened, for example by colds or other infections. Heavy sun exposure, stress or menstruation can also trigger symptoms.
Virpax inhibits the virus' ability to reproduce, allowing the infection to regress.
You should contact your doctor if you feel no improvement or if symptoms do not diminish after 5 days.
2. WHAT DO I NEED TO KNOW BEFORE USING VIRPAX?
Never use VIRPAX 50 mg, muco-adhesive buccogingival tablet :
- if you are allergic (hypersensitive) to aciclovir or to any of the other ingredients of this medicine (listed in section 6);
- if you are allergic to milk or milk derivatives.
Warnings and precautions
- Virpax may be accidentally swallowed. If Virpax is accidentally swallowed, it is recommended that you drink a glass of water.
- Talk to your doctor before using this medicine if your immune system is weakened (in connection with another disease affecting the immune system, e.g. AIDS or organ transplantation) or because of treatment affecting your immune system (e.g. immunosuppressive drugs). Virpax should not be taken in these cases, as it has never been used in patients with weakened immune systems (immunocompromised patients).
- We do not know whether Virpax works if used after the appearance of blisters or inflammation. Therefore, use Virpax only when you experience the first symptoms of cold sores (itching, redness or tingling).
Children and adolescents
This medicine must not be used in children and adolescents under 18 years of age.
Other medicines and VIRPAX 50 mg, muco-adhesive buccogingival tablet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
VIRPAX 50 mg, buccogingival mucoadhesive tablet with food and drink
You can eat and drink normally once VIRPAX is in place.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Virpax may be used during pregnancy and lactation.
Driving and using machines
This medicine has no effect on the ability to drive vehicles or use machines.
VIRPAX 50 mg, buccogingival mucoadhesive tablet contains milk protein concentrate with traces of lactose and sodium lauryl sulfate.
This medicine contains 5.2 mg sodium laurilsulfate per tablet.
Sodium laurilsulfate may cause local skin reactions (such as a stinging or burning sensation) or increase skin reactions caused by other products when applied to the same area.
If your doctor has informed you that you are intolerant to certain sugars (lactose, etc.), contact him/her before taking this medicine.
3. HOW SHOULD VIRPAX BE TAKEN?
Always use this medicine exactly as instructed in the package leaflet or by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Recommended dose :
One tablet to be stuck on the gum per coldsore episode.
DO NOT SWALLOW TABLET
If accidentally swallowed, drink a glass of water.
Instructions for proper use
This medication should be applied to the upper gums (just above the incisor) as soon as the first symptoms or signs of cold sores appear (itching, redness or tingling):
- Before applying the tablet, locate where the tablet is to be applied to the upper gum above an incisor.
- You'll notice that the tablet has a rounded face and a flat face engraved with "AL21". Apply the tablet with a dry finger immediately after removing it from the blister pack.
- For comfort, whichever side of the lip the first signs or symptoms appear on, place the rounded side against the gum. The tablet can be stuck to either side.
- To make sure the tablet adheres properly to the gum, press your finger on the outside of your upper lip for 30 seconds, without pressing directly on the tablet.
- If your mouth is dry, drink water to moisten your gums before applying the tablet. The tablet can also be applied to the inside of the lip rather than against the gum.
Once applied, the tablet stays in place and gradually dissolves over the course of the day.
Once applied, do not suck, chew or swallow the tablet.
All situations that may interfere with the tablet's adhesion should be avoided:
- Touching or pressing on the tablet already in place.
- Chewing gum.
- Brushing your teeth while the tablet is in place.
If this medication does not adhere or falls out within the first 6 hours, the same tablet should be reinserted immediately. If the tablet cannot be reinserted, a new tablet must be applied.
If you accidentally swallow a Virpax tablet, drink a glass of water.
If the tablet is dropped or swallowed within the first 6 hours after application, it should be replaced only once.
If the tablet is accidentally dropped or swallowed after 6 hours, it should not be replaced.
If you have taken more VIRPAX 50 mg, muco-adhesive buccogingival tablet, than you should have: Consult your doctor or pharmacist immediately, even if the risk of overdosage is low, given the low absorption into the blood after taking Virpax.
View instructions for administration and special recommendations on :
Domain name/link being created for access to the ANSM-approved video.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Common side effects (may affect up to 1 in 10 people):
- Headache
- Pain at application site
Uncommon side effects (which may affect up to 1 in 100 people):
- Dizziness
- nausea
- Irritation at application site
- Aphta
- Gingival pain
- Redness
Reporting side effects
If you experience any side effects, please tell your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO CONSERVE VIRPAX 50 mg, muco-adhesive buccogingival tablet?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging and blister after "EXP". The expiration date refers to the last day of that month.
Store at a temperature not exceeding 30°C.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What VIRPAX 50 mg buccogingival mucoadhesive tablet contains
- The active substance is laciclovir. Each mucoadhesive buccogingival tablet contains 50 mg of laciclovir.
- Other ingredients: hypromellose, milk protein concentrate with traces of lactose, sodium lauryl sulfate, magnesium stearate, microcrystalline cellulose, povidone, colloidal anhydrous silica.
What VIRPAX 50 mg, muco-adhesive buccogingival tablet is and what it contains
This medicine is a white to yellowish, 8 mm muco-adhesive buccogingival tablet with a rounded face and a flat face marked "AL21".
Each box of Virpax contains 1 or 2 unit blister(s) of 1 tablet.
Marketing authorization holder
VECTANS PHARMA
230 BUREAUX DE LA COLLINE
92213 SAINT-CLOUD CEDEX
Marketing authorization holder
ZAMBON FRANCE S.A.
13 RUE RENE JACQUES,
92130 ISSY-LES-MOULINEAUX
Manufacturer
FARMEA
10 RUE BOUCHE THOMAS
ZAC DORGEMONT
49000 ANGERS CEDEX
Product names in member states of the European Economic Area
This medicinal product is authorized in the member states of the European Economic Area under the following names: In accordance with current regulations.
[To be completed subsequently by the holder].
The last date on which this leaflet was revised was :
[to be completed later by the holder]
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Other
Detailed information on this drug is available on the ANSM (France) website.
Health education advice :
Cold sores or herpes labialis are due to an infection caused by a virus called Herpes simplex. After a primary infection, the virus persists in the body without causing any symptoms.
The virus can sometimes be reactivated by events such as fatigue, menstruation, fever, emotion or exposure to the sun.reactivated, leading to the appearance of clusters of vesicles (blisters) around the lips, known as fever blisters. These vesicles are contagious until scabs appear, a sign of healing.
There are localized warning signs at the usual site of the lesion, usually a burning and/or tingling sensation.
These signs are important to know:
- treatment must be started as soon as they appear, to prevent viral multiplication and limit the development of fever blisters,
- It's also as soon as they appear that you should observe the following rules of hygiene to reduce the risk of transmitting the virus to yourself and those around you.
- Avoid close contact, such as kissing, with those around you.
- NEVER KISS AN INFANT.
- Wash your hands thoroughly after any contact with the lesion.
- During treatment, to avoid spreading the lesions, never rub your eyes or eyelids with your hands, and if you wear contact lenses, never moisten them with your saliva.
- Avoid touching or scratching the lesions.
Never use VIRPAX on any other part of your herpes outbreak, TAKE YOUR DOCTOR'S ADVICE.
On the other hand, aciclovir cannot act on viruses that persist in a latent state in the body, and aciclovir does not prevent recurrences after treatment has been discontinued.