NOTICE
ANSM - Last updated: 13/11/2013
Name of the medicinal product
PREXIDINE 0.12 PER CENT, mouth wash solution
chlorhexidine
framed
Read this leaflet carefully before you start using 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, consult a physician.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS PREXIDINE 0.12 PER CENT, mouthwash solution AND IN WHAT CASES IS IT USED?
2. WHAT TO DO ABOUT BEFORE USING PREXIDINE 0.12 PER CENT, mouthwash solution?
3. HOW TO USE PREXIDINE 0.12 PER CENT, mouth wash solution?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE PREXIDINE 0.12 PER CENT, mouthwash solution?
6. ADDITIONAL INFORMATION
1. WHAT IS PREXIDINE 0.12 PER CENT, mouthwash solution AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
STOMATOLOGY / LOCAL TREATMENT WITH ANTISEPTICAL SCREENING
(A: digestive system and metabolism)
Therapeutic indications
This medication is a mouthwash.
It is indicated for local topical treatment of infections of the mouth, or in care after surgery of the oral cavity.
2. WHAT TO DO ABOUT BEFORE USING PREXIDINE 0.12 PER CENT, mouthwash solution?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not use PREXIDINE 0.12 PER CENT, mouthwash solution if:
· allergy to chlorhexidine.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR SURGICAL DENTIST OR YOUR STOMATOLOGIST AND / OR YOUR PHYSICIAN OR YOUR PHARMACIST
Precautions for use; special warnings
Take special care with PREXIDINE 0.12 PER CENT, mouth wash solution :
Special warnings
DO NOT LEAVE THIS MEDICINE FOR CHILDREN.
Prolonged use of this medication is undesirable as it can alter the natural microbial balance of the mouth and throat.
If signs of infection worsen or if there is no improvement after 5 days:
CONSULT YOUR SURGER-DENTIST OR YOUR STOMATOLOGIST
Precautions for use
· Do not get into eyes.
· Do not insert the product into the nose or ears.
· DO NOT SWALLOW.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE OPINION OF YOUR SURGICAL DENTIST, YOUR STOMATOLOGIST OR YOUR PHARMACIST.
Interaction with other medicines
Taking or using other medicines:
Do not use several drugs containing an antiseptic at the same time or in close proximity.
IN ORDER TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, YOU MUST SIGNAL SYSTEMATICALLY ANY OTHER TREATMENT IN PROGRESS TO YOUR SURGICAL DENTIST, YOUR STOMATOLOGIST OR YOUR PHARMACIST.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
This medication should be used with caution during pregnancy and lactation.
In general, you should seek advice from your doctor or pharmacist before taking any medication.
Sport
Not applicable.
Effects on ability to drive or use machines
Driving and using machines:
Under normal conditions of use of PREXIDINE, this medication is not likely to affect your ability to drive and use machines.
List of excipients with known effect
Not applicable.
3. HOW TO USE PREXIDINE 0.12 PER CENT, mouth wash solution?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS.
200 ml bottle: For each mouth wash, use the measuring cup by filling it to the mark (15 ml). In the absence of a cup, use the contents of a tablespoon of solution (15 ml).
Flasks of 55 ml and 500 ml: Use the contents of a tablespoon of solution (15 ml).
Rinse the mouth thoroughly for about one minute with the pure solution.
Method and route of administration
Use locally in mouthwash.
DO NOT SWALLOW.
This solution must be used pure, undiluted.
The mouthwash should be done AFTER brushing teeth and rinsing.
Frequency and timing of administration of the drug
The number of mouthwashes is 1 to 3 per day.
Duration of treatment
Do not continue treatment for more than 5 days without medical advice.
Symptoms and Instructions for Overdose
If you used more PREXIDINE 0.12 PER CENT, mouthwash solution you should not have:
An overdose is not expected under normal conditions of use of this solution in mouthwash
If you accidentally swallow this PREXIDINE solution, you may experience symptoms such as pain in the esophagus or stomach. In all cases, consult your dentist, or your stomatologist or doctor.
In children, if this solution is accidentally swallowed, contact your doctor, because of the presence of alcohol.
In addition, this drug contains terpene derivatives, which can lower the epileptogenic threshold and lead to excessive doses if PREXIDINE is accidentally swallowed, neurological accidents in children (convulsions) and elderly agitation and confusion). Observe the recommended dosage and duration of treatment (see section "Dosage" and "Mode and route of administration").
If accidentally splashed in your eyes, rinse immediately and abundantly with clear water and consult your doctor.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist for more information.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, PREXIDINE 0.12 PER CENT, mouthwash solution is likely to have unwanted effects, although not everyone is subject to it.
· Brown color of the tongue and teeth, especially in tea or coffee drinkers, disappearing when the treatment is stopped.
· Possible allergic reactions: irritations, skin reactions, swelling of the salivary glands. If you experience any of these symptoms, stop treatment and see a doctor.
· Possibility of alteration of the taste or burning sensation of the tongue at the beginning of treatment.
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 PREXIDINE 0.12 PER CENT, mouthwash solution?
Keep out of the reach and sight of children.
Expiration date
Do not use PREXIDINE 0.12 PER CENT, mouthwash solution after the expiry date which is stated on the outer packaging.
The expiry date refers to the last day of the month.
Storage conditions
Store at a temperature not exceeding + 25 ° C.
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 contains PREXIDINE 0.12 PER CENT, mouthwash solution?
The active substance is :
Chlorhexidine gluconate solution at 20 percent
Amount corresponding to chlorhexidine gluconate ............................................ .............................. 0.120 g
For 100 ml of mouthwash solution
The other components are :
Saccharin, glycerol, polysorbate 80, alcohol, levomenthol, mint flavor *, purified water.
* Composition of Mint Flavor: ethanol, menthol, menthyl acetate, mint essential oil.
Pharmaceutical form and content
What is PREXIDINE 0.12 PER CENT, mouth wash solution and contents of the pack?
This medication is in the form of a mouthwash solution; flask of 55 ml, 200 ml or 500 ml.
Not all pack sizes may be marketed.
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
laboratory erempharma
25 rue Greffulhe
92300 levallois perret
exploiting
laboratory erempharma
25 rue Greffulhe
92300 levallois perret
Maker
EXPANSCIENCE LABORATORIES
Street of the Four Girls
28230 EPERNON
or
DELPHARM TOURS
"The Baraudiere"
37170 CHAMBRAY LES TOURS
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.
