NOTICE
ANSM - Updated on : 28/01/2022
Product name
ELUDRILPRO, mouthwash solution
Chlorhexidine digluconate, chlorobutanol hemihydrate
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Please read this leaflet carefully before using this medicine, as it contains important information for you.
You must always use this medicine in strict accordance with the information provided in this leaflet or by your doctor or pharmacist.
- 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 or pharmacist. 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 after 5 days.
What does this leaflet contain?
1. What is ELUDRILPRO, mouthwash solution and what is it used for?
2. What do I need to know before using ELUDRILPRO, mouthwash solution?
3. How do I use ELUDRILPRO mouthwash solution?
4. What are the possible side effects?
5. How should I store ELUDRILPRO mouthwash solution?
6. Package contents and other information.
1. WHAT IS ELUDRILPRO, mouthwash solution AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: STOMATOLOGICAL PREPARATIONS - ANTIINFECTIOUSAND ANTISEPTIC FOR LOCAL ORAL TREATMENT - ATC code: A01AB03
This medicine is a combination of 2 antiseptics (chlorhexidine digluconate and chlorobutanol hemihydrate) which acts by combating bacteria present on teeth (dental plaque) and in the mouth.
By limiting the development of bacterial plaque, it also helps reduce gingival inflammation.
This medicine is used as an adjunctive local treatment for infections of the mouth (gingivitis, slight bleeding), as well as during post-operative care in odontostomatology.
This situation occurs
- if you suffer from an oral pathology,
- after oral surgery.
This medicine is reserved for adults and children over 6 years of age.
You should consult your doctor if you do not feel better or feel worse after 5 days.
2. WHAT DO I HAVE TO KNOW BEFORE USING ELUDRILPRO, mouthwash solution?
Never use ELUDRILPRO, mouthwash solution:
- if you are allergic to chlorhexidine, chlorobutanol or any of the other ingredients listed in section 6,
- in children under 6 years of age.
Warnings and Precautions
Talk to your doctor or pharmacist before using ELUDRILPRO, mouthwash solution.
This medicine is for topical use as a mouthwash.
Do not swallow the solution.
Do not get this product in your eyes, nose or ears. In case of contact, wash immediately with plenty of water.
Prolonged use may lead to discoloration of the tongue, teeth, dentures and filling materials. This discoloration is reversible and can be avoided by brushing teeth daily before using the mouthwash, or by using a dental solution for dentures and filling materials.
If symptoms persist for more than 5 days and/or fever develops, the advice of a doctor or dental surgeon should be sought.
This drug may cause severe generalized allergic reactions due to its chlorhexidine content, which may occur within minutes of exposure.
This medicine contains terpene derivatives which, in excessive doses and if swallowed, may cause neurological disorders in the form of convulsions in children.
Children
This drug is not recommended for children under 6 years of age.
If the drug is given to a child over 6 years of age, you must ensure that the child does not drink it, as it contains alcohol.
Other drugs and ELUDRILPRO, mouthwash solution
The active substance chlorhexidine is incompatible with certain toothpastes.
Mouthwash solution should therefore only be used after a short period of time following tooth brushing and careful rinsing of the mouth. Toothpaste and mouthwash solution should be used only briefly after each other.
Tell your doctor or pharmacist if you are using, have recently used or may use any other medicines.
ELUDRILPRO mouthrinse 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.
This medicine must not be taken during pregnancy or while breast-feeding.
Driving and use of machinery
No studies have been carried out on the ability to drive vehicles or use machines with ELUDRILPRO, mouthwash solution.
ELUDRILPRO, mouthwash solution contains :
- 7.2 g alcohol (ethanol) per 20 ml dose of solution which is equivalent to 361.6 mg/ml. The amount per dose in this medication is equivalent to less than 184 ml beer or 74 ml wine. Since this drug is a mouthwash solution and is therefore not swallowed, the amount of alcohol contained in this drug is unlikely to have any noticeable effect in the usual clinical context. However, care should be taken to ensure that children using the product do not swallow it. The presence of alcohol should be taken into account in cases of alcohol withdrawal.
- Less than 1 mmol sodium (23 mg) per 10-15 ml dose of solution, i.e. essentially "sodium-free".
- Lexcipient "cochineal red A (E124)" which may cause allergic reactions.
3. HOW TO USE ELUDRILPRO, mouthwash solution?
Always use this product exactly 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 2 times a day (to be diluted in the measuring cup). If necessary, this dose can be increased to 3 times a day, although the maximum dose is 20 ml (to be diluted), 3 times a day.
This product should be used as a mouthwash.
- Brush your teeth before each use and rinse your mouth thoroughly with water before using ELUDRILPRO, mouthwash solution.
- Pour the recommended dose into the measuring cup
- Fill to the top with lukewarm water (to dilute the medication)
- Then rinse until the measuring cup is empty.
- Do not swallow the mouthwash solution. Hold the solution for 1 minute, then spit it out into a sink once the mouthwash is finished. 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 rinse.
The measuring cup should be rinsed and dried after each use. Keep the bottle and measuring cup together in the carton until next use, in a safe place where your child cannot see or reach them. Discard the measuring cup when the bottle is finished.
Treatment duration can be up to 2 weeks for gingival inflammation and periodontitis. Treatment may be extended beyond 2 weeks only on medical advice.
Use in children
RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS OF AGE
If you have used more ELUDRILPRO, mouthwash solution than you should have
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 of the throat and esophagus may occur. If a large quantity is swallowed, you may experience symptoms of digestive discomfort (nausea, vomiting, stomach pain and diarrhoea), slight incoordination of movement or liver toxicity.
This medicine contains terpene derivatives as excipients which may cause convulsions in children if ingested in excessive doses.
Contact your doctor, dentist or poison control center if a large quantity has been swallowed.
Due to the alcohol content of the undiluted product, accidental ingestion of large quantities of mouthwash by children requires immediate medical attention for appropriate action.
If you forget to use ELUDRILPRO, mouthwash solution
Do not take a double dose to make up for the one you forgot to take.
If you stop using ELUDRILPRO, mouthwash solution
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Undesirable effects encountered with ELUDRILPRO, mouthwash solution are generally mild and disappear after treatment has been discontinued.
The following side effects may occur (frequency unknown):
- Severe skin rash, itching, swelling of the mouth, face or neck, which may lead to breathing difficulties. This could be an allergic reaction to the drug. If you notice any of these effects, you should stop treatment immediately and contact your doctor as soon as possible.
- Change in taste or burning sensation of the tongue, particularly at the start of treatment. These effects disappear with continued treatment.
- Brown discoloration of the tongue. This is not harmful and disappears when treatment is stopped.
- Staining of teeth, dentures and tooth restoration materials. This discoloration can easily be avoided by daily brushing, and can be removed by your dentist.
- Swelling of the salivary glands (parotid glands), which disappears when treatment is stopped.
- Skin detachment inside the mouth. If this happens, dilute the mouthwash with 50% water and seek medical advice.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. 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 Regional Pharmacovigilance Centers.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE ELUDRILPRO, mouthwash solution?
Keep out of sight and reach of children.
Do not use after the expiration date indicated on the bottle. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
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 ELUDRILPRO mouthwash solution contains
- The active ingredients are :
Chlorhexidine digluconate.......................................................................................... 0.100 g
In the form of chlorhexidine digluconate solution.................................................... 0.5 ml
Chlorobutanol hemihydrate ................................................................................................................................. 0.5 g
Per 100 ml
Alcoholic strength: 42.8% (v/v)
- Other ingredients: glycerol, 96% ethanol, docusate sodium, levomenthol, alcoholic solution of mint essential oil, purified water, cochineal red A (E124).
What ELUDRILPRO mouthrinse solution is and what it contains
This medicine comes as a light-pink mouthwash solution in 15 ml single-dose bottles, or in 90 ml, 200 ml or 500 ml bottles with graduated measuring cups.
Not all presentations may be marketed.
Marketing authorization holder
PIERRE FABRE MEDICAMENT
LES CAUQUILLOUS
81500 LAVAUR
Marketing authorization holder
PIERRE FABRE MEDICAMENT
PARC INDUSTRIEL DE LA CHARTREUSE
81106 CASTRES CEDEX
Manufacturer
PIERRE FABRE MEDICAMENT PRODUCTION
ETABLISSEMENT PROGIPHARM
RUE DU LYCEE
ZONE INDUSTRIELLE DE CUIRY
45500 GIEN
Product 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
Detailed information on this drug is available on the ANSM (France) website.
