In this manual :
1. WHAT IS HEXTRIL MINT 0.1 PER CENT, mouthwash solution AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE USING HEXTRIL MINTS 0.1 PER CENT, mouthwash solution
3. HOW DO I USE HEXTRIL MINTS 0.1 PER CENT, mouthwash solution?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE HEXTRIL MINTS 0.1 PER CENT, mouthwash solution?
6. ADDITIONAL INFORMATION
1. WHAT IS HEXTRIL MENTH 0.1 PER CENT, mouthwash solution AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Not applicable.
This medicine is indicated in the local treatment of mouth disorders or in care after surgery of the oral cavity.
2. WHAT YOU SHOULD KNOW BEFORE USING HEXTRIL MENTH 0.1 PER CENT, mouthwash solution
List of information needed before taking the medicine
Not applicable.
Do not use HEXTRIL MINTS 0.1 PER CENT, mouthwash solution:
- If you are allergic (hypersensitive) to hexetidine or any of the other ingredients in HEXTRIL MINT 0.1 PER CENT, mouthwash solution.
Precautions for use; special warnings
Use caution with HEXTRIL MINT 0.1 PER CENT, mouthwash solution:
KEEP THIS MEDICINE OUT OF THE REACH OF CHILDREN.
Prolonged use (more than 5 days) of this medication is not desirable as it may alter the natural microbial balance of the mouth.
If symptoms worsen or do not improve after 5 days: CONSULT YOUR DOCTOR.
Interactions with other medicines
Taking or using other medicines
Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines 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 breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
List of excipients with a notable effect:ethanol.
3. HOW TO USE HEXTRIL MENTHE 0.1 PER CENT, 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.
Dosage
This mouthwash solution can be used pure or diluted in mouthwashes:
1 dose 2 to 3 times a day.
Use the dosing cup provided to measure the dose.
Pure: pour the solution into the measuring cup up to the notch indicating 15 ml.
Diluted: if painful symptoms occur, use the solution diluted to ½ cup
Pour the solution up to the notch indicating 15 ml and fill to the top of the cup with water.
Rinse the dosing cup thoroughly after each use.
If you feel that the effect of HEXTRIL MENTHE 0.1 PER CENT, mouthwash solution is too strong or too weak, consult your doctor or pharmacist.
Duration of treatment
The duration of use is limited to 5 days.
Symptoms and instructions in case of overdose
If you have used more HEXTRIL MINTS 0.1 PER CENT Mouthwash than you should have, you should not take more than the recommended dosage:
An overdose is not expected under normal conditions of use.
Some components of this medication (essential oils) may cause neurological accidents such as convulsions in children at excessive doses.
In case of old or recent epilepsy, ask your doctor for advice.
Instructions in case of missed doses
If you forget to take HEXTRIL MINTS 0.1 PER CENT, mouthwash solution:
Do not take a double dose to make up for the dose you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, HEXTRIL MINTS 0.1 PER CENT Mouthwash Solution may have side effects, although not everyone is susceptible.
- Allergic skin and mucous membrane reactions, most often swelling of the face, neck and mouth, have been reported.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please inform your doctor or pharmacist.
5. HOW TO USE HEXTRIL MINT 0.1 PER CENT, Mouthwash Solution
Keep out of the reach and sight of children.
Do not use HEXTRIL MENTH 0.1 PERCENT, mouthwash solution after the expiry date stated on the bottle.
Store at a temperature not exceeding 25°C.
Keep the bottle in the outer packaging, protected from light.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of the medicine in the sewage system 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 HEXTRIL MENTHE 0.1 PER CENT, mouthwash solution contain?
The active substance is:
Hexetidine ......................................................................................................................................... 0.10 g
For 100 ml of mouthwash solution.
The other components are:
Quinoline yellow and patent blue V, purified water, polysorbate 60, saccharin sodium, 96% ethanol, citric acid monohydrate, mint flavour.
Pharmaceutical form and content
What is HEXTRIL MINT 0.1 PER CENT, mouthwash solution and what does it contain?
This medicine comes in the form of a mouthwash solution. Bottles of 30, 200 or 400 ml.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1, rue Camille Desmoulins
92130 ISSY LES MOULINEAUX
Operator
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1, rue Camille Desmoulins
92130 ISSY LES MOULINEAUX
Manufacturer
FAMAR ORLEANS
5 AVENUE DE CONCYR
45071 ORLEANS CEDEX 2
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 of approval of this package insert was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
Not applicable.
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