NOTICE
ANSM - Last updated: 09/12/2011
Name of the medicinal product
DOLODENT, gingival solution
framed
Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, seek medical attention.
· If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS DOLODENT, gingival solution AND IN WHAT CASES IS IT USED?
2. BEFORE YOU USE DOLODENT, gingival solution?
3. HOW TO USE DOLODENT, gingival solution?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE DOLODENT, gingival solution?
6. ADDITIONAL INFORMATION
1. WHAT IS DOLODENT, gingival solution AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
PREPARATIONS FOR ODONTO-STOMATOLOGY / LOCAL TREATMENT WITH ANTISEPTIC AND ANTALGIUM SCREENING
(A: digestive system and metabolism)
Therapeutic indications
This medication is recommended for local use in cases of gum pain during dental flare-ups.
2. BEFORE YOU USE DOLODENT, gingival solution?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not use DOLODENT, a gingival solution for allergy to known local anesthetics and other constituents.
Precautions for use; special warnings
Take special care with DOLODENT, gingival solution
Special warnings and precautions for use
Follow the advice for use and the dosage recommended in this leaflet.
CONSULT YOUR DOCTOR if symptoms worsen (especially if the fever increases, if the pain is severe).
CONSULT YOUR DOCTOR in the absence of improvement after 5 days.
Do not use for prolonged periods due to the presence of a local anesthetic (amylein).
Interaction with other medicines
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy - Breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Sport
Athletes' attention is drawn to the fact that this medicinal product contains an active ingredient (local anesthetic) capable of inducing a positive reaction from the tests performed during the doping tests.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO USE DOLODENT, gingival solution?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
A MEDICAL ADVICE MUST BE REQUESTED BEFORE THE APPLICATION OF THIS MEDICINE.
Dosage
Two to three applications per day on the painful gum massaging gently with the clean finger.
Method and route of administration
Strict local use. Gingival pathway.
This medication should be applied locally. Do not swallow.
Frequency of Administration
Two to three applications per day.
Duration of treatment
Treatment should not exceed 5 days without medical advice.
Symptoms and Instructions for Overdose
If you take more DOLODENT, gingival solution than you should:
An overdose is not expected under normal conditions of use of this gingival solution.
Instructions for omission of one or more doses
If you forget to take DOLODENT, gingival solution:
Do not take a double dose to make up for the single dose that you have forgotten to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, DOLODENT, gingival solution is likely to have unwanted effects, although not everyone is subject to it.
Possibility of allergic reactions: skin reactions, swelling of the face. In this case, stop the treatment and notify the doctor.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE DOLODENT, gingival solution?
Keep out of the reach and sight of children.
Expiration date
Do not use DOLODENT, gingival solution after the expiry date which is stated on the vial.
Storage conditions
No special storage conditions.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does DOLODENT contain, gingival solution?
The active substance is:
Amyloin hydrochloride .............................................. .................................................. ...................... 0.75 g
For 100 g of solution.
The other components are:
Glycerol, ascorbic acid, caramel aroma (monopropylene glycol, water, vanillin, piperonal, maltol, lactic acid, hydrated MCP, acetylmethylcarbinol, dodecalactone delta, heptalactone gamma, triacetin), purified water.
Pharmaceutical form and content
What is DOLODENT, gingival solution and contents of the outer packaging?
Gingival solution, bottles of 20, 27 and 36 g.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
GILBERT Laboratories
Avenue of General de Gaulle
BP 115
14204 Herouville-Saint-Clair Cedex
exploiting
GILBERT Laboratories
Avenue of the General de Gaulle
BP 115
14204 Herouville Saint-Clair Cedex
Maker
GILBERT Laboratories
Avenue of the General de Gaulle
BP 115
14204 Herouville Saint-Clair Cedex
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.