In this manual :
1. WHAT IS ELUDRILPRO, mouthwash solution AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE USING ELUDRILPRO, mouthwash solution?
3. HOW TO USE ELUDRILPRO, mouthwash solution?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE ELUDRILPRO, mouthwash solution?
6. ADDITIONAL INFORMATION
1. WHAT IS ELUDRILPRO, mouthwash solution AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Not applicable.
It is recommended as an adjunctive local treatment of oral cavity disorders and during post-operative care in odonto-stomatology.
2. WHAT DO YOU NEED TO KNOW BEFORE USING ELUDRILPRO, mouthwash solution?
List of information needed before taking the medicine
Not applicable.
Never use ELUDRILPRO, mouthwash solution
The use of ELUDRILPRO, mouthwash solution is contraindicated in case of hypersensitivity(allergy) to chlorhexidine, chlorobutanol or other components of the solution.
Precautions for use; special warnings
Be careful with ELUDRILPRO, mouthwash solution
Do not get product in contact with eyes and nose. Do not get the product into the ear canal.
In case of persistence of symptoms beyond 5 days and/or associated fever, the course of action should be reassessed.
Prolonged use may lead to staining of teeth, fillings and dentures.
Interactions with other drugs
Taking or using other drugs
The simultaneous or successive use of other antiseptics should be avoided because of possible interference (antagonism, inactivation.....).
Talk to your doctor or pharmacist if you are taking or have recently taken any other medication, including medication obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breastfeeding
Pregnancy and lactation
During pregnancy or breastfeeding, do not hesitate to ask your doctor or pharmacist for advice before taking any medication.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
List of excipients with a notorious effect:
Alcohol.
Cochineal red A (E124).
3. HOW TO USE ELUDRILPRO, mouthwash solution?
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS OF AGE.
Mode of administration
Local use as a mouthwash.
Do not swallow.
Usual dosageTo be used as a mouthwash: 10 to 15 ml of solution twice a day (to be diluted in the measuring cup by filling up to the upper line with lukewarm water): carry out the mouthwash until the measuring cup is used up.
If necessary, this dosage can be increased to 3 times a day, knowing that the maximum dose is 20 ml (to be diluted), 3 times a day.
Brush your teeth before each use and rinse your mouth thoroughly with water before using ELUDRILPRO, mouthwash solution.
For the single-dose bottle, dilute the contents of the bottle in half a glass of water and perform the mouthwash.
Duration of treatment
The duration of treatment can be up to 2 weeks in gingival inflammation and parondontitis. The duration of treatment can be prolonged beyond 2 weeks only on medical advice.
Symptoms and instructions in case of overdose
If you have used more ELUDRILPRO Mouthwash Solution than expected
An overdose is not expected under normal conditions of use of this mouthwash solution. However, in the event of systemic passage(by the general route), manifestations of neurological toxicity may appear. These should be treated in a specialist environment.
Instructions in case of omission of one or more doses
If a dose of ELUDRILPRO Mouthwash has been missed
Do not take a double dose to make up for the dose you missed.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, ELUDRILPRO, mouthwash solution is likely to have undesirable effects, although not everyone is subject to them.
There is a risk of sensitization to one of the components of the solution.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO STORE ELUDRILPRO, mouthwash solution
Keep out of the reach and sight of children.
Do not use ELUDRILPRO mouthwash solution after the expiry date stated on the bottle.
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does ELUDRILPRO mouthwash solution contain?
The active ingredients are
Chlorhexidine digluconate solution .......................................................................................... 0.500 ml
Chlorobutanol hemihydrate ................................................................................................................ 0.500 g
Per 100 ml.
Alcoholic strength: 42,8 % v/v.
Other components are:
Glycerol, 96 per cent ethanol, docusate sodium, levomenthol, alcoholic solution of mint essential oil, purified water, cochineal red A (E124).
Pharmaceutical form and content
What is ELUDRILPRO mouthwash solution and what does it contain?
This medicine is available as a mouthwash solution in 15 ml, 90 ml, 200 ml or 500 ml bottles.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
PIERRE FABRE MEDICAMENT
45, PLACE ABEL GANCE
92000 BOULOGNE
Operator
PIERRE FABRE MEDICAMENT
29, AVENUE DU SIDOBRE
81106 CASTRES CEDEX
Manufacturer
PIERRE FABRE MEDICAMENT PRODUCTION
RUE DU LYCEE
ZONE INDUSTRIELLE DE CUIRY
45500 GIEN
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this package insert was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Not applicable.
Français
English
