HERPMED LABIALE

Patient Information Leaflet

HerpMed Labiale 50 mg mucoadhesive buccal tablets

aciclovir
Read this entire leaflet carefully before you start using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor, pharmacist, or nurse has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need further information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 5 days.

Contents of this leaflet:

1. What HerpMed Labiale is and what it is used for
2. What you need to know before using HerpMed Labiale
3. How to use HerpMed Labiale
4. Possible side effects
5. How to store HerpMed Labiale
6. Contents of the pack and other information

1. What HerpMed Labiale is and what it is used for

HerpMed Labiale contains the active substance aciclovir and belongs to a group of medicines called antivirals.
HerpMed Labiale is used for the treatment of recurrent episodes of cold sores caused by the Herpes simplex virus in adults with a healthy immune system. HerpMed Labiale should be applied directly to the gum as soon as the first symptoms (burning, tingling, and itching) or signs (redness and swelling) appear.
The virus causes blisters or ulcers, mainly on the lips, but sometimes in other parts of the face. Viral infection may be triggered when the immune system is weakened, for example by colds or other infections. Strong sunlight, stress, or the menstrual cycle may also trigger symptoms.
HerpMed Labiale inhibits the virus's ability to replicate, thereby helping the infection to subside.
If you do not feel better or if your symptoms have not improved after 5 days, you must consult your doctor.

2. What you need to know before using HerpMed Labiale

Do not use HerpMed Labiale

• If you are allergic (hypersensitive) to aciclovir or to any of the other components of this medicine (listed in section 6).
• If you are allergic to milk or milk-derived products.

Warnings and precautions

• HerpMed Labiale may be accidentally ingested. If accidental ingestion occurs, it is recommended to drink a glass of water.
• If you have a weakened immune system (due to another disease affecting the immune system, such as AIDS, or due to treatment affecting your immune system, e.g. immunosuppressive drugs), talk to your doctor before using this medicine. HerpMed Labiale should not be used in such cases.
• It is not known whether HerpMed Labiale is effective when used after blisters have already appeared. Therefore, you should use HerpMed Labiale only after noticing 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 HerpMed Labiale
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
HerpMed Labiale with food, drinks and alcohol
You may eat and drink normally after applying HerpMed Labiale to the gum.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine. HerpMed Labiale may be used during pregnancy and breastfeeding.
Driving and using machines
HerpMed Labiale does not affect the ability to drive or operate machinery.
HerpMed Labiale contains lactose (milk protein concentrate with traces of lactose) and sodium lauryl sulfate
If your doctor has diagnosed you with an intolerance to certain sugars (e.g. lactose), contact him/her before taking this medicine.
This medicine contains 5.2 mg of sodium lauryl sulfate per tablet.
Sodium lauryl sulfate may cause skin irritation (stinging or burning sensation) or intensify skin reactions caused by other medicines when applied to the same area.

3. How to use HerpMed Labiale

Use HerpMed Labiale exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one HerpMed Labiale tablet applied once only.

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

DO NOT SWALLOW HerpMed Labiale
If accidentally swallowed, drink a glass of water.

Instructions for appropriate use
This medicine should be applied to the upper gum, above a front tooth, as soon as the first symptoms or signs of cold sore appear (such as itching, redness, or tingling):

• Before applying the tablet, locate the area on the upper gum above the front tooth.
• Apply one tablet using a dry finger immediately after removing it from the blister. As you can see, the tablet has one rounded side and one flat side bearing the inscription "AL21".
• For greater comfort, apply the rounded side to the upper gum, although either side of the tablet may be used.
• If your mouth is dry, it is recommended to drink water to moisten the gum before applying the tablet. The tablet may be used if it adheres inside the lip instead of on the gum. Once applied, the tablet stays in place and gradually dissolves throughout the day.

How to apply HerpMed Labiale

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

Food and drinks can be consumed normally while HerpMed Labiale is in place. The tablet must not be sucked, chewed, or swallowed.
All situations that could interfere with tablet adhesion should be avoided, such as:

• touching or pushing the tablet after application
• chewing gum
• brushing teeth during the day while the tablet is in place.

If this medicine does not adhere or comes off within the first 6 hours, the same tablet must be repositioned immediately. If the tablet cannot be repositioned, a new tablet must be applied.
If a HerpMed Labiale tablet is accidentally swallowed, drink a glass of water. If the tablet is swallowed within 6 hours after application, it should be replaced only once.
If HerpMed Labiale comes off or is accidentally swallowed after 6 hours, there is no need to replace the tablet.
The shape of the tablet may change as a result of saliva absorption and adaptation to the shape of your gum.

If you use more HerpMed Labiale than you should
Contact your doctor or pharmacist immediately, although the risk of overdose is low due to the limited absorption of aciclovir into the bloodstream following administration of HerpMed Labiale.

4. Possible side effects

Like all medicines, this one can cause side effects, although not everybody experiences 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
• Aphthous stomatitis (afta)
• Gingival pain (pain in the gums)
• Redness

If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store HerpMed Labiale

• 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 stated on the packaging and blister after Exp. The expiry date refers to the last day of that month.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What HerpMed Labiale contains

• The active substance is: aciclovir. Each mucoadhesive buccal tablet contains 50 mg of aciclovir.
• The other components are: hypromellose, milk protein concentrate with traces of lactose, sodium lauryl sulfate, magnesium stearate, microcrystalline cellulose, povidone, anhydrous colloidal silica.

Description of the appearance of HerpMed Labiale and contents of the pack

• This medicinal product appears as an 8 mm mucoadhesive buccal tablet, white to slightly yellowish in colour, with one rounded side and one flat side bearing the engraved mark "AL21".
• Each cardboard box of HerpMed Labiale contains 2 unit-dose blisters with 1 tablet each.
  Marketing Authorization Holder
  VECTANS PHARMA
  230 Bureaux de la Colline Bâtiment D, 6è étage
  92213 Saint-Cloud FRANCE
  Phone: +33.(0)1.41.21.90.16

Manufacturer
Farméa
10 rue Bouché Thomas
ZAC d'Orgemont
49 000 Angers - France

This medicinal product is authorized in the European Economic Area Member States under the following names:
Denmark, Finland, Sweden, United Kingdom, Norway, France: Sitavig
Italy: HerpMed Labiale