In this manual :
1. WHAT IS HEXTRIL 0.1 PERCENT Mouthwash, Bottle AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE USING HEXTRIL 0.1 PER CENT Mouthwash, bottle?
3. HOW DO I USE HEXTRIL 0.1 PERCENT Mouthwash Vial?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW DO I USE HEXTRIL 0.1 PER CENT Mouthwash, bottle?
6. ADDITIONAL INFORMATION
1. WHAT IS HEXTRIL 0.1 PERCENT Mouthwash, bottle AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
ANTISEPTIC.
This medicine is indicated for the local adjunctive treatment of mouth disorders.
2. WHAT YOU SHOULD KNOW BEFORE USING HEXTRIL 0.1 PER CENT, mouthwash, bottle
List of information needed before using this medication
Not applicable.
Never use HEXTRIL 0.1 PER CENT Mouthwash, bottle if you
- If you are allergic (hypersensitive) to hexetidine or any of the other ingredients in HEXTRIL 0.1 PER CENT, mouthwash, bottle.
- In children under 6 years of age.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Use caution with HEXTRIL 0.1 PERCENT, mouthwash, bottle:
Special Warnings:
This product contains terpene derivatives in the formula which, in excessive doses, may cause neurological accidents such as convulsions in infants and children. Observe the recommended dosage and duration of treatment (see How to use HEXTRIL 0.1 PERCENT Mouthwash, bottle).
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose.
This medicine contains an azo colouring agent (azorubin E122) and may cause allergic reactions.
Precautions for use
Do not exceed 10 days of treatment: beyond that, consult your doctor.
IN CASE OF DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
IN ORDER TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINES, YOU MUST SYSTEMATICALLY INFORM YOUR DOCTOR OR PHARMACIST OF ANY OTHER TREATMENT IN PROGRESS.
NEVER LEAVE WITHIN THE REACH OF CHILDREN.
In case of old or recent epilepsy, SEEK ADVICE FROM YOUR DOCTOR.
Interactions with other medicines
Use of other medications
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 lactation
Pregnancy and breastfeeding
If you are breastfeeding, it is preferable not to use this medicine.
In general, during pregnancy and breastfeeding, always ask your doctor or pharmacist for advice before taking any medicine.
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with a known effect
List of excipients with a notable effect: azo dye (azorubin E122), ethanol.
3. HOW TO USE HEXTRIL 0.1 PERCENT, mouthwash, bottle
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS OF AGE.
Method of administration
Local use as a mouthwash.
DO NOT SWALLOW.
Frequency of administration
This mouthwash solution can be used pure or diluted: 1 dose 2 to 3 times a day.
Pure: pour HEXTRIL into the measuring cup up to the notch indicating 15 ml.
Diluted: in case of appearance of painful manifestations. Use the solution diluted to ½:
Pour HEXTRIL into the measuring cup up to the notch indicating 15 ml. Then fill to the top of the cup with water.
Rinse the measuring cup well after each use.
Duration of treatment
The duration of use is limited to 10 days.
Symptoms and instructions in case of overdose
If you have used more HEXTRIL 0.1 PERCENT Mouthwash, bottle than you should have:
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 in excessive doses.
In case of old or recent epilepsy, ask your doctor for advice.
Instructions in case of omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, HEXTRIL 0.1 PERCENT Mouthwash, Bottle is susceptible to adverse reactions, although not everyone is susceptible:
Allergic skin and mucous membrane reactions, most commonly 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 DO I USE HEXTRIL 0.1 PERCENT Mouthwash, bottle?
Keep out of the reach and sight of children.
Do not use HEXTRIL 0.1 PERCENT Mouthwash, bottle after the expiration date stated on the package.
Store at a temperature not exceeding +25° C and keep the primary packaging in the outer packaging.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of medicines 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 HEXTRIL 0.1 PER CENT, mouthwash, bottle contain?
The active substance is :
Hexetidine ..................................................................................................................................... 0,1000 g
For one 100 ml bottle
Other components are:
Polysorbate 60, sodium saccharin, methyl salicylate, clove essential oil, menthol, anise essential oil, peppermint essential oil, eucalyptus essential oil, azorubin 85% (E 122), citric acid monohydrate, 96% ethanol, purified water.
Pharmaceutical form and content
What is HEXTRIL 0.1 PER CENT mouthwash and what does it contain?
This medicine is in the form of a mouthwash. Box of one bottle of 30, 100, 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
MCNEIL SANTE GRAND PUBLIC
1 RUE CAMILLE DESMOULINS
92130 ISSY LES MOULINEAUX
Operator
MCNEIL SANTE GRAND PUBLIC
1 RUE CAMILLE DESMOULINS
92130 ISSY LES MOULINEAUX
Manufacturer
famar orleans
5, avenue de Concyr
45071 ORLEANS
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 website of Afssaps (France).
Information reserved for health professionals
Not applicable.
Not applicable.
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