NOTICE
ANSM - Updated on: 09/26/2017
Name of the drug
ELUDRIL 0.5 ml / 0.5 g per 100 ml, mouthwash solution
Chlorhexidine digluconate / chlorobutanol hemihydrate
Box
Read all of this leaflet carefully before using this medicine as it contains important information for you.
You should always use this medicine by carefully following the information provided in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effect not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse after 5 days.
What does this booklet contain ?
1. What is E LUDRIL 0.5 ml / 0.5 g per 100 ml, mouthwash solution and in which cases it is used?
2. What should you know before using E LUDRIL 0.5 ml / 0.5 g per 100 ml, mouthwash solution?
3. How to use E LUDRIL 0.5 ml / 0.5 g per 100 ml, mouthwash solution?
4. What are the possible side effects?
5. How to store E LUDRIL 0.5 ml / 0.5 g per 100 ml, mouthwash solution?
6. Contents of the pack and other information.
1. WHAT ELUDRIL 0.5 ml / 0.5 g per 100 ml, mouthwash solution IS AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: STOMATOLOGICAL PREPARATIONS - ANTI-INFECTIOUS AND ANTISEPTICS FOR LOCAL ORAL TREATMENT, ATC code: A01AB03
This medication is a combination of 2 antiseptics (chlorhexidine digluconate and chlorobutanol hemihydrate) which works by fighting bacteria on the teeth (plaque or plaque) and in the mouth.
By limiting the development of bacterial plaque, it also helps reduce gum inflammation.
This medication is used as a local adjunct treatment for infections of the mouth as well as during post-operative care in odonto-stomatology.
This situation occurs :
• if you suffer from an oral pathology ,
• after an oral operation .
This medication is reserved for adults and children over 6 years of age.
You should talk to your doctor if you do not feel better or if you feel worse after 5 days.
2. WHAT YOU NEED TO KNOW BEFORE USING ELUDRIL 0.5 ml / 0.5 g per 100 ml, mouthwash solution?
Never use ELUDRIL 0.5 ml / 0.5 g per 100 ml, mouthwash solution:
· if you are allergic to the active substances or to any of the other ingredients of this medicine mentioned in section 6.
· in children under 6 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using ELUDRIL 0.5 ml / 0.5g per 100 ml, mouthwash solution.
This medication is for local use in mouthwash.
Do not swallow the solution.
Do not put the product in your eyes, nose or ears. In case of contact, wash immediately with plenty of water.
Prolonged use may expose the tongue, teeth, dentures or filling materials to discoloration. This coloring is reversible and can be avoided by daily brushing of the teeth before using mouthwash, or by a dental solution for dental prostheses and filling materials.
In case of persistence of symptoms beyond 5 days and / or associated fever, the opinion of a doctor or a dental surgeon should be sought.
The presence of alcohol must be taken into account in the event of alcohol withdrawal.
Children
This medication is not recommended for children under 6 years of age .
In case the medicine is given to a child over 6 years old, you must make sure that the child does not swallow it because this medicine contains alcohol.
Other medicines and ELUDRIL 0.5 ml / 0.5 g per 100 ml, mouthwash solution
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
The active substance, chlorhexidine is incompatible with certain toothpastes.
The mouthwash solution should therefore only be used after a short time after brushing the teeth and after rinsing the mouth thoroughly. There should be a short delay between the use of toothpaste and the mouthwash solution.
ELUDRIL 0.5 ml / 0.5 g per 100 ml, mouthwash solution with food and drink
Not applicable.
Pregnancy and breast feeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
This medication should not be used during pregnancy and breastfeeding.
Driving and using machines
No study has not been performed on the ability to use or drive machines or vehicles with ELUDRIL 0.5 ml / 0.5 g per 100 ml, mouthwash solution.
ELUDRIL 0.5 ml / 0.5 g per 100 ml, mouthwash solution contains
Not applicable.
3. HOW TO USE ELUDRIL 0.5 ml / 0.5 g per 100 ml, mouthwash solution?
Always use this medication exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
The recommended dose is 10 to 15 ml of solution twice a day (to be diluted in the measuring cup)
This medication should be used as a mouthwash:
· Brush your teeth before each use and rinse your mouth thoroughly with water before using ELUDRIL 0.5 ml / 0.5 g per 100 ml, mouthwash solution.
· Pour the recommended dose into the measuring cup
· Fill up to the top line with lukewarm water (to dilute the medication)
· Then carry out the mouthwash until the measuring cup is exhausted
· Do not swallow the mouthwash solution. Spit it in a sink after the mouthwash is complete and do not rinse your mouth.
For the 15 ml single-dose bottle, dilute the contents of the bottle in half a glass of water and perform the mouthwash.
The duration of treatment can be 2 weeks in gingival inflammations and periodontitis. The duration of treatment can only be extended beyond 2 weeks on medical advice.
Use in children
RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS OLD
If you use more ELUDRIL 0.5 ml / 0.5 g per 100 ml, mouthwash solution than you should
An overdose is not expected under normal conditions of use of this mouthwash solution.
If swallowed, local effects such as a burning sensation in the mouth and throat, local irritation in the throat and esophagus may occur. If a large amount has been swallowed, you may have symptoms of digestive discomfort (nausea, vomiting, stomach pain and diarrhea), slight movement inconsistency, or liver toxicity.
Contact your doctor, dentist or poison control center if a large amount has been swallowed.
Due to the alcohol content of the undiluted product, accidental ingestion of large amounts of mouthwash by children requires immediate medical attention for appropriate action.
If you forget to use ELUDRIL 0.5 ml / 0.5 g per 100 ml, mouthwash solution
Do not take a double dose to make up for the dose you forgot to take.
If you stop using ELUDRIL 0.5 ml / 0.5 g per 100 ml, mouthwash solution
Not applicable.
If you have any further questions on the use of this medicine, ask 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.
The side effects encountered with ELUDRIL 0.5 ml / 0.5 g per 100 ml, mouthwash solution are generally mild and disappear after stopping treatment.
The following side effects may occur (frequency not known):
· Rash on the skin, itching, swelling of the mouth, face or neck which may cause difficulty in breathing. This could be an allergic reaction to the medication. If you notice these effects, you should stop this treatment immediately and contact your doctor as soon as possible.
· Change in taste or burning sensation of the tongue, especially at the start of treatment. These effects disappear when the treatment is continued.
· Brown coloring of the tongue. This is not harmful and disappears when treatment is stopped.
· Staining of teeth, dentures and tooth restoration materials. This coloration can easily be avoided by daily brushing of the teeth, and can be removed by your dentist.
· Swelling of the salivary glands (parotid glands) which disappears when treatment is stopped.
· Peeling of the skin inside the mouth. If this happens, you should dilute the mouthwash with 50% water and seek medical advice.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effect 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 network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ELUDRIL 0.5 ml / 0.5 g per 100 ml, mouthwash solution?
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 bottle. The expiration date refers to the last day of this month.
Do not store above 25 ° C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist to discard any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What ELUDRIL contains 0.5 ml / 0.5g per 100 ml, mouthwash solution
· The active substances are:
Chlorhexidine digluconate ............................................... ................................................. 0.100 g
In the form of chlorhexidine digluconate solution .......................................... ................ 0.5 ml
Chlorobutanol hemihydrate ................................................ .................................................. ....................................... 0.5 g
For 100 ml
· The other ingredients are: glycerol, 96 percent ethanol, sodium docusate, levomenthol, alcoholic solution of mint essential oil, purified water, cochineal red A (E124).
What ELUDRIL 0.5 ml / 0.5g per 100 ml, mouthwash solution and contents of the pack
This medication is in the form of a clear, pink mouthwash solution in a 15 ml, 90 ml, 200 ml or 500 ml bottle with a measuring cup except for the 15 ml.
Not all presentations may be marketed.
Marketing authorization holder
PIERRE FABRE MEDICAMENT
45 PLACE ABEL GANCE
92100 BOULOGNE
Marketing authorization operator
PIERRE FABRE MEDICAMENT
45 PLACE ABEL GANCE
92100 BOULOGNE
Maker
PIERRE FABRE MEDICAMENT PRODUCTION
PROGIPHARM ESTABLISHMENT
RUE DU LYCEE
45500 GIEN
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
<{MM / YYYY}> <{month YYYY}.>
Other
Detailed information on this drug is available on the ANSM website (France).
