HerpesMed® 50 mg mucoadhäsive Buccaltabletten

When a cold sore is coming on: act early

One aciclovir buccal tablet per episode – on the upper gum instead of directly on the lip

The familiar tingling, itching, or burning can be the first sign of a recurrent cold sore. HerpesMed is intended for adults with an intact immune system who want targeted treatment at these early signs. The special feature: The tablet is attached to the upper gum and not applied directly to the affected lip area.

Each muco-adhesive buccal tablet contains 50 mg aciclovir. HerpesMed inhibits the ability of the herpes simplex virus to multiply. Once applied, the tablet remains in place and slowly dissolves over the course of the day; eating and drinking can be continued as usual.

A single tablet is used per episode. Early application is crucial, as it is not known whether HerpesMed is still effective once blisters have already appeared. The tablet must not be sucked, chewed, or swallowed.

How is it used?

HerpesMed contains the active substance aciclovir and belongs to a group of medicines called antivirals.

HerpesMed is used in adults with an intact immune system to treat recurrent cold sores (recurrent herpes labialis) caused by the herpes simplex virus. HerpesMed must be applied directly to the gum (not to the actual sore spot) as soon as the first symptoms (burning, tingling, itching) or signs (redness, swelling) appear.

The virus causes blisters or sores, mainly on the lips, but sometimes on other parts of the face. The viral infection can be activated when the immune system is weakened, e.g. by colds or other infections. Strong sunlight, stress, or menstruation can also trigger symptoms.

HerpesMed inhibits the virus's ability to multiply, thereby helping to clear the infection.

You must consult a doctor if symptoms worsen or do not improve after 5 days.

What should you consider before taking it?

HerpesMed must not be used:

- if you are allergic to aciclovir or any of the other ingredients of this medicine listed in section 6.

- if you are allergic to milk or milk products.

Warnings and precautions

− Accidental swallowing of HerpesMed can occur. If HerpesMed is accidentally swallowed, it is recommended to drink a glass of water.

− Talk to your doctor before using this medicine if you have a weakened immune system (caused by another illness, e.g. AIDS) or if your immune system is compromised by medical treatment (e.g. with immunosuppressants). In this case, HerpesMed is not recommended.

− It is not known whether HerpesMed is effective if applied only after blisters have already appeared. Therefore, HerpesMed should only be used when you feel the first symptoms of a cold sore (itching, redness, or tingling).

− You must also consult a doctor in the event of frequently recurring cold sore episodes (more than 4 per year) or if you notice that the frequency of episodes has recently increased or that the lesions are spreading to other parts of the body.

Children and adolescents

This medicine must not be used in children and adolescents under 18 years of age.

Using HerpesMed with other medicines

Tell your doctor or pharmacist if you are using/taking, have recently used/taken, or might use/take any other medicines.

Using HerpesMed with food, drink, and alcohol

After placing HerpesMed on the gum, you can eat and drink as usual.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

HerpesMed is not expected to have any effects on the unborn child.

However, as a precautionary measure, the use of HerpesMed during pregnancy is only recommended if strictly necessary.

Breast-feeding

The use of HerpesMed during breast-feeding is not expected to affect the breastfed infant.

However, as a precautionary measure, use during breast-feeding is only recommended if strictly necessary.

Driving and using machines

This medicine has no or negligible influence on your ability to drive or use machines.

HerpesMed contains milk protein concentrate with traces of lactose and sodium dodecyl sulfate

Please only use this medicine after consulting your doctor if you know that you suffer from a sugar intolerance.

This medicine contains milk protein, which may cause allergic reactions in patients with severe hypersensitivity or allergy to milk protein.

This medicine contains 5.2 mg sodium dodecyl sulfate per tablet.

Sodium dodecyl sulfate may cause local skin reactions (such as a stinging or burning sensation) or increase skin reactions caused by other products applied to the same skin area.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially "sodium-free".

How is the medicine to be taken?

Always use HerpesMed exactly as described in this leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is a single tablet of HerpesMed per cold sore episode. This is to be applied to the gum as soon as the first symptoms or signs of a cold sore appear.

You must consult a doctor if symptoms worsen or do not improve after 5 days.

DO NOT SWALLOW HERPESMED

If you swallow it accidentally, drink a glass of water.

Instructions for proper use

If your mouth is dry, it is recommended to drink some water before using the tablet to moisten the oral mucosa.

How to place HerpesMed

Before placing the tablet, locate the position on the upper gum above the second incisor (lateral incisor).

Remove the tablet from the blister pack.

The tablet can be placed on either the right or the left side of the gum, regardless of which side the first signs and symptoms of the cold sore appear on.

This medicine is to be placed on the upper gum (not on the actual sore spot), directly above the second incisor (application to the gum). Place the tablet using a dry finger immediately after removing it from the blister pack. You will notice that the tablet has a rounded side and a flat side embossed with "AL21". Place the tablet with the flat side against your dry fingertip. Place the rounded side of the tablet onto your upper gum. If the tablet sticks to the inside of the lip instead of the gum, the medicine will still work.

Hold the tablet in place by applying gentle pressure with your finger to the outside of the upper lip for 30 seconds to ensure adhesion.

Once placed, the tablet remains in place and slowly dissolves throughout the day.

Special recommendations

Food and drink can be consumed as usual while HerpesMed is in place.

The tablet must not be sucked, chewed, or swallowed.

All situations that could affect the adhesion of the tablet should be avoided:

• Touching or pressing the tablet once placed

• Chewing gum

• Brushing your teeth during the day once the tablet has already been placed

If you accidentally swallow a tablet of HerpesMed:

• drink a glass of water;

• If the tablet is swallowed within the first 6 hours after application, it should be replaced only once.

If HerpesMed does not adhere or falls off within the first 6 hours of placement:

• the same tablet should be replaced immediately;

• If the tablet cannot be repositioned, a new tablet must be used.

If HerpesMed falls off or is accidentally swallowed after 6 hours, it should not be replaced.

The shape of the tablet may change as it absorbs saliva in order to adapt to the shape of your gum.

Use in children and adolescents

This medicine must not be used in children and adolescents under 18 years of age.

If you have used more HerpesMed than you should

Contact your doctor or pharmacist immediately, even though the risk of overdose is low due to the minimal absorption of aciclovir into the bloodstream after applying HerpesMed.

What are the possible side effects?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people):

• Headache

• Pain at the application site

Uncommon side effects (may affect up to 1 in 100 people):

• Dizziness

• Nausea

• Irritation at the application site

• Inflamed areas in the mouth

• Gum pain

• Redness

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system:

Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen)

Traisengasse 5

1200 VIENNA

AUSTRIA

Fax: + 43 (0) 50 555 36207

Website: http://www.basg.gv.at/

By reporting side effects, you can help provide more information on the safety of this medicine.

Special storage instructions

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

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the outer carton and the blister pack after "EXP". The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Special instructions on contents

- The active substance is aciclovir. Each muco-adhesive buccal tablet contains 50 mg aciclovir.

- The other ingredients are: hypromellose, milk protein concentrate with traces of lactose, sodium dodecyl sulfate, magnesium stearate, microcrystalline cellulose, povidone, colloidal anhydrous silica.

What HerpesMed looks like and contents of the pack

- This medicine is a white to light yellow, 8 mm muco-adhesive buccal tablet with a rounded side and a flat side embossed with "AL21".

- Each outer carton of HerpesMed contains 1 or 2 single-dose blister packs of 1 tablet each.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Vectans Pharma

230 Bureaux de la Colline

92213 Saint-Cloud Cedex

France

Manufacturer

Farméa

10 rue Bouché Thomas

ZAC d'Orgemont

49 000 Angers

France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

A. MENARINI Pharma GmbH, Vienna

MA No.: 142422

This medicinal product is authorised in the Member States of the European Economic Area (EEA) and in the United Kingdom (Northern Ireland) under the following names:

Belgium: Vionox 50 mgmuco-adhesieve buccale tablet

Bulgaria: Klivis 50 mg, Мукоадхезивна букална таблетка

Denmark: Virono 50 mg, resoribletter, slimhindeklæbende

Germany: Sitavig 50 mg mucoadhäsive Buccaltablette

Estonia: Bravilon

Finland: Virono 50 mg, bukkaalitabletit, kiinnittyviä.

France: VIRPAX 50 mg, comprimé buccogingival muco adhésif

Iceland: Virono 50 mg, Kinntafla á slímhúð

Italy: HerpMed Labiale 50 mg compresse buccali mucoadesive

Croatia: Bravilon 50 mg mukoadhezivne bukalne tablete

Latvia: Bravilon 50 mg gļotādai pielīpošās aiz vaiga lietojamās tabletes

Lithuania: Bravilon 50 mg lipnioji žando gleivinės tabletė

Luxembourg: Vionox 50 mg, Comprimé buccogingival muco-adhésif

Netherlands: Virono 50 mg, Muco-adhesieve buccale tablet

Norway: Virono 50 mg resoribletter, slimhinneklebende

Austria: HerpesMed 50 mg mucoadhäsive Buccaltabletten

Poland: Aciclovirum Vectans

Portugal: Herpmed 50 mg, Comprimido bucal mucoadesivo

Romania: Bravilon 50 mg comprimate bucale mucoadezive

Sweden: Virono 50 mg, buckaltabletter, häftande

Slovakia: Bravilon 50 mg,mukoadhezívna bukálna tableta

Slovenia: Vopir 50 mg mukoadhezivna bukalna tableta

Spain: VIRMEN 50 mg, Comprimido bucal mucoadhesivo

Czech Bravilon

Republic:

Hungary: Bravilon 50 mg szájnyálkahártyához bukkális tabletta

United Sitavig 50 mg, muco-adhesive buccal tablets

Kingdom

(Northern Ireland):

This leaflet was last revised in June 2026.