NOTICE
ANSM - Updated on : 03/04/2023
Product name
DENTOBAUME, gingival solution
Damylen hydrochloride, Levomenthol
Box
Please read this leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine exactly as it is described 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.
What does this leaflet contain?
1. What is DENTOBAUME gingival solution and what is it used for?
2. What do I need to know before using DENTOBAUME, solution gingivale?
3. How do I use DENTOBAUME gingival solution?
4. What are the possible side effects?
5. How should DENTOBAUME gingival solution be stored?
6. Package contents and other information.
1. WHAT IS DENTOBAUME, gingival solution AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code: Affection bucco-dentaire Local anaesthetic (A. digestive system and metabolism)
Symptomatic treatment of acute gingivodental pain.
You should consult your doctor if you do not feel any improvement or if you feel worse.
2. WHAT DO I HAVE TO KNOW BEFORE USING DENTOBAUME, gingival solution?
Never use DENTOBAUME, gingival solution:
- if you are allergic (hypersensitive) to damylein hydrochloride, levomenthol or any of the other ingredients of this product, as listed in section 6.
- if you have a history of allergy to local anesthetics.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using DENTOBAUME, gingival solution.
Special warnings
DENTOBAUME provides rapid relief of pain, but is only an emergency measure pending a visit to a dental specialist, which is always essential. Disappearance of pain in no way implies a cure.
This product contains terpene derivatives which, in excessive doses, can cause neurological accidents such as convulsions in infants and children. Follow the recommended dosage and duration of treatment (see How to use DENTOBAUME, gingival solution).
Precautions for use
This product is intended for adults and children over 10 years of age.
In case of old or recent epilepsy, SEEK ADVICE FROM YOUR DOCTOR.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Children
FOR ADULTS AND CHILDREN OVER 10 YEARS OF AGE.
Other medicines and DENTOBAUME, gingival solution
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
DENTOBAUME, gingival solution 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.
In general, during pregnancy and when breast-feeding, always ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant or breast-feeding, it is preferable not to use this medicine.
Driving and using machines
Not applicable.
DENTOBAUME, solution gingivale contains leugenol and lisoeugenol.
This medicine contains clove oil containing leugenol and lisoeugenol, which may cause allergic reactions.
3. HOW DO I USE DENTOBAUME, gingival solution?
Always use this medicine exactly as instructed in this leaflet or as directed by your doctor, pharmacist or nurse. Check with your doctor, pharmacist or nurse if in doubt.
Dosage
FOR ADULTS AND CHILDREN OVER 10 YEARS OF AGE.
Place a solution-impregnated pad in contact with the gum or painful tooth.
Repeat if necessary.
Mode and route of administration
Local use.
If you have used more DENTOBAUME, gingival solution than you should have
Consult your doctor or pharmacist immediately.
An overdose is not expected under normal conditions of use of this gingival solution.
If you forget to use DENTOBAUME, gingival solution
Do not take a double dose to make up for the one you forgot to take.
If you stop using DENTOBAUME, gingival solution
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor, pharmacist or nurse.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this product may cause undesirable effects, but these do not always occur in everyone.
In particular: local irritation, allergy.
Due to the presence of terpene derivatives, there is a risk of convulsions in infants if recommended doses are not followed:
- risk of convulsions in infants and children,
- possibility of agitation and confusion in the elderly.
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 are helping to provide more information on drug safety.
5. HOW DO I USE DENTOBAUME, gingival solution?
Keep out of sight and reach of children.
Do not use after the expiration date indicated on the packaging. The expiration date refers to the last day of that month.
No special precautions for external storage.
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 DENTOBAUME gingival solution contains
- The active ingredients are :
Damylein hydrochloride................................................................................................... 0.80 g
Levomenthol................................................................................................................... 0.80 g
Per 100 g.
- Other excipients include: Benzoin tincture, glycerol, clove essential oil.
Clove oil contains leugenol and lisoeugenol.
What DENTOBAUME gingival solution is and what it contains
This medicine is a gingival solution.
4 ml bottle.
Marketing authorization holder
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Marketing authorization holder
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Manufacturer
LABORATOIRE TRADIPHAR
176, RUE DE LARBRISSEAU
59000 LILLE
or
PHARMA DEVELOPPEMENT
ZONE INDUSTRIELLE
CHEMIN DE MARCY
58800 CORBIGNY
Drug 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].
Other
Not applicable.
