NOTICE
ANSM - Updated on : 27/06/2022
Product name
LABIAMEO, granules
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as instructed in this leaflet or by your doctor or pharmacist.
- 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 or pharmacist. 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 8 days.
What does this leaflet contain?
1. What is LABIAMEO granules and what are they used for?
2. What do I need to know before taking LABIAMEO, granules?
3. How should LABIAMEO granules be taken?
4. What are the possible side effects?
5. How do I keep LABIAMEO granules?
6. Package contents and other information.
1. WHAT IS LABIAMEO, granules AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: Homeopathic medicine
LABIAMEO, granules is a homeopathic medicine traditionally used to treat outbreaks of localized herpes labialis (also known as "cold sores").
2. WHAT DO I HAVE TO KNOW BEFORE TAKING LABIAMEO, granules?
If your doctor has informed you that you are intolerant to certain sugars, contact him/her before taking this medicine.
Never take LABIAMEO granules
- if you are allergic to any of the active ingredients or to any of the other ingredients listed in section 6.
Warnings and precautions
- This medicine is not recommended for patients with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases).
- This drug is not recommended for patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases).
- Severely immunocompromised patients (e.g. AIDS patients or bone marrow transplant patients) should consult a physician regarding treatment of any infection.
Children
In the case of a primary infection, medical advice should be sought before use in children.
Other drugs and LABIAMEO, granules
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
LABIAMEO, granules with food and drink
Not applicable.
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.
LABIAMEO, granules may be used during pregnancy and while breast-feeding.
Driving and use of machinery
Not applicable.
LABIAMEO granules contain lactose and sucrose.
3. HOW DO I TAKE LABIAMEO, granules?
Always take this medicine exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
For adults and children over 6 years of age.
Melt 5 granules under the tongue 3 to 5 times a day. Take at intervals as soon as symptoms improve, and stop as soon as symptoms disappear.
Treatment should be started as soon as possible after the first signs of cold sores (pain, burning/itching/pitting or redness) appear.
If symptoms worsen or persist beyond 8 days, consult a doctor.
In the case of a first infection, medical advice is required before use on children.
Method of administration
Sublingual route
Use in children and adolescents
Not applicable
If you have taken more LABIAMEO granules than you should have
Consult your doctor or pharmacist.
If you forget to take LABIAMEO, granules
Do not take a double dose to make up for the one you forgot to take.
If you stop taking LABIAMEO, granules
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. 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 Regional Pharmacovigilance Centers.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW DO I USE LABIAMEO, granules?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box. The expiration date refers to the last day of the month.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What LABIAMEO granules contain
- The active ingredients are :
Apis mellifica 15 CH............................................................................................................. 0.01 mL
Rhus toxicodendron 15 CH................................................................................................... 0.01 mL
Cantharis 15 CH................................................................................................................... 0.01 mL
Mezereum 15 CH.................................................................................................................. 0.01 mL
For one tube of 4 g of granules
- Other components are : Sucrose, lactose.
What LABIAMEO granules are and what they contain
This medicine comes in the form of granules packaged in tubes. One box contains 3 tubes of 4 g.
Marketing authorization holder
BOIRON
2 avenue de l'Ouest Lyonnais
69510 Messimy
France
Marketing authorization holder
BOIRON
2 avenue de l'Ouest Lyonnais
69510 Messimy
France
Manufacturer
BOIRON
2 avenue de l'Ouest Lyonnais
69510 Messimy
France
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder]
< {MM/YYYY}>< {month/YYYY}.>
Other
Detailed information on this drug is available at on the ANSM (France) website.
HEALTH EDUCATION ADVICE
If you have a "fever blister", a few hygiene precautions are essential to prevent the lesions from spreading and transmitting the virus to those around you:
- avoid kissing those close to you, especially young children,
- don't touch or scratch the "fever blister" to avoid bacterial superinfection,
- don't rub your eyes or eyelids after touching herpes labialis lesions: there is a significant risk of self-contamination of the eyes,
- wash your hands after touching the lesion,
- if in doubt about the nature of your lesion, ask your pharmacist or doctor for advice.