NOTICE
ANSM - Updated: 28/08/2017
Name of the drug
DENTEX, solution for mouthwash
Hydrogen peroxide
framed
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medicine exactly as described in this leaflet or by your dental specialist or doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If any of the side effects occur, talk to your dental specialist or doctor or pharmacist. This also applies to any undesirable effects that are not mentioned in this leaflet. See section 4.
· You need to talk to your dental specialist or your doctor if you feel no improvement or if you feel worse.
Do not let this medicine within the reach of children.
What does this booklet contain ?
1. What is DENTEX Mouthwash Solution and what is it used for?
2. What information do you need to know before using DENTEX, a solution for mouthwash?
3. How to use DENTEX, solution for mouthwash?
4. What are the possible side effects?
5. How to store DENTEX, solution for mouthwash?
6. Contents of the package and other information.
1. WHAT DENTEX is for mouthwash AND WHAT IT IS USED FOR
Pharmacotherapeutic group - ATC code: Stomatological preparations - Anti-infectives for local oral treatment - Hydrogen peroxide - A01AB02
This medicine is a mouthwash for oro-oral hygiene in case of minor irritation of the mucous membrane and gums.
2. WHAT YOU NEED TO KNOW BEFORE USING DENTEX, a solution for mouthwash?
Never use DENTEX, solution for mouthwash:
· if you are allergic (hypersensitive) to hydrogen peroxide or any of the other ingredients of this medicine, listed in section 6.
If in doubt, it is essential to seek the advice of your dental specialist or pharmacist.
Warnings and precautions
Talk to your dental specialist or pharmacist before using DENTEX, a mouthwash solution .
DO NOT SWALLOW.
The consultation of the doctor or dental specialist becomes indispensable:
· if irritation persists for more than 7 days,
· in case of severe irritation,
· if the irritation is due to the wearing of prostheses or orthodontic appliances,
· if there is inflammation of the mucous membranes,
· if there is fever.
Too high doses of hydrogen peroxide can damage the mucous membranes and prolonged use of hydrogen peroxide can lead to reversible hypertrophy of the papillae of the tongue, also called the "villous black tongue". Therefore, it is not recommended to use DENTEX, solution for mouthwash too long and too high doses.
Avoid contact with the eyes.
If in doubt, do not hesitate to seek the advice of your dental specialist or your doctor or pharmacist.
children
Not applicable.
Other medicines and DENTEX, solution for mouthwash
Inform your dental specialist or your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
DENTEX, solution for mouthwash with food and drinks
Not applicable.
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your dental specialist or doctor or pharmacist for advice before taking this medicine.
During pregnancy, there may be some changes and irritations of the oral mucosa, which may not be controlled by oral hygiene alone. In this case, DENTEX, solution for mouthwash, can only be used on the advice of your dental specialist and only for a short time.
The use of DENTEX, solution for mouthwash is possible during breastfeeding.
Sport
Not applicable.
Driving and using machines
Not applicable.
DENTEX, solution for mouthwash contains
Not applicable.
3. HOW TO USE DENTEX, solution for mouthwash?
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your dental specialist or your doctor or pharmacist if in doubt.
The solution for mouthwash DENTEX is indicated in adults and children over 6 years for local use in mouthwash.
DENTEX solution for mouthwash is ready for use. Oro-oral use.
Rinse with 10 ml of solution (ie the contents of the dosing cap filled to the mark corresponding to 10 ml) for about a minute and then spit out. Use 3 times daily (after meals and at bedtime) or as recommended by the dental specialist.
Adults and children over 12 years old: to use as described above.
For children 6 to 12 years: to use under the supervision of an adult.
The duration of use must not exceed 7 days.
If you have used more DENTEX, solution for mouthwash than you should have:
Immediately consult your doctor or pharmacist.
Overdose is not expected with DENTEX, solution for mouthwash, which is a dilute solution of hydrogen peroxide. Symptoms of an overdose would rather be associated with more concentrated solutions (30-40%) of hydrogen peroxide.
In case of accidental ingestion of an excessive amount of DENTEX, the levomenthol it contains may cause convulsions, especially in infants and children.
If you forget to use DENTEX, solution for mouthwash:
Not applicable.
If you stop using DENTEX, solution for mouthwash:
Not applicable.
If you have any further questions about the use of this medicine, ask your dental specialist or your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Cases of irritation and inflammation of the oral mucosa have been reported, especially at high doses or with prolonged use. These reactions disappear when you stop using DENTEX, a solution for mouthwash.
Declaration of side effects
If you get any side effects, talk to your dental specialist, doctor or pharmacist. This also applies to any undesirable effects that are not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information on the safety of the medicine.
5. HOW TO STORE DENTEX, solution for mouthwash?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of this month.
Store at a temperature not exceeding 25 ° C.
Do not dispose of any medication in the sewage system or garbage. Ask your pharmacist to eliminate medications you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What DENTEX contains, solution for mouthwash
· The active substance is:
Hydrogen peroxide.............................................. .................................................. ............. 1.50 g
In the form of 30% hydrogen peroxide solution
For 100 ml.
· The other components are:
Purified water, 70% non-crystallizable sorbitol solution, 96% ethanol, poloxamer 338, polysorbate 20, methyl salicylate, levo-menthol, sodium saccharin, brilliant blue FCF (E133).
What DENTEX, solution for mouthwash and contents of the pack
This medicine is in the form of a solution for mouthwash. Bottle of 300 ml.
Marketing Authorization Holder
COLGATE PALMOLIVE
9-11, RUE DU DEBARCADERE
92700 Colombes
Operator of the marketing authorization
ALLOGA FRANCE
ZAC Chapotin South
Professor Dargent Street
69970 CHAPONNAY
Maker
COLGATE-PALMOLIVE MANUFACTURING (POLAND) SP. Z OO
AL COLGATE 2
58-100 SWIDNICA
POLAND
or
BCM LIMITED
THANE ROAD
NOTTINGHAM NG90 2PR
UNITED KINGDOM
Names of the medicine in the member states of the European Economic Area
This medicine is authorized in the member states of the European Economic Area under the following names: In accordance with the regulations in force.
to be completed later by the holder
The last date this leaflet was revised is:
to be completed later by the holder
Other
Detailed information on this medicine is available on the ANSM website (France).