NOTICE
ANSM - Last updated: 04/05/2017
Name of the medicinal product
HEXTRIL 0.1 PER CENT, mouthwash, vial
hexetidine
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed 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 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 experience no improvement or feel less well after 10 days.
· Do not use this medication for children.
What is in this leaflet?
1. What is HEXTRIL 0.1 PER CENT, mouthwash, vial and in which cases is it used?
2. What should I know before using HEXTRIL 0.1 PER CENT, mouthwash, bottle?
3. How to use HEXTRIL 0.1 PER CENT, mouthwash, bottle?
4. What are the possible side effects?
5. How to store HEXTRIL 0.1 PER CENT, mouthwash, bottle?
6. Package contents and other information.
1. WHAT IS HEXTRIL 0.1 PER CENT, mouthwash, vial AND WHAT USE IS IT USED FOR?
Pharmacotherapeutic group: ANTI-INFECTIOUS AND ANTISEPTIC FOR LOCAL ORAL TREATMENT, ATC code: A01AB12 .
This medication is indicated in the local topical treatment of mouth disorders.
2. BEFORE YOU USE HEXTRIL 0,1 PER CENT, mouthwash, bottle?
Never use HEXTRIL 0.1 PER CENT, mouthwash, bottle:
· if you are allergic to the active substance or to any of the other ingredients of this medication mentioned in section 6.
· in children under 6 years of age.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Warnings and Precautions
This solution is for external use only; the solution should not be swallowed.
This specialty contains terpenic derivatives in the formula that can cause, in excessive doses, neurological convulsion-like symptoms in infants and children. Observe the recommended dosage and treatment time (see How to use HEXTRIL 0.1 PER CENT, mouth wash, vial).
Not suitable for persistent symptoms
Do not exceed 10 days of treatment: Beyond see your doctor.
IN ORDER TO AVOID INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, YOU MUST SIGNAL SYSTEMATICALLY ANY OTHER TREATMENT IN PROGRESS TO YOUR DOCTOR OR YOUR PHARMACIST.
NEVER LEAVE TO CHILDREN.
In case of epilepsy old or recent, REQUEST ADVICE TO YOUR DOCTOR.
This medication contains small amounts of ethanol (alcohol), less than 100 mg per dose.
This medication contains an azo dye (azorubine E122) and may cause allergic reactions.
Talk to your doctor or pharmacist before using HEXTRIL 0.1 PER CENT , mouthwash, bottle.
Children and Youth
Not applicable.
Other medicines and HEXTRIL 0.1 PER CENT, mouthwash, vial
Inform your doctor or pharmacist if you are taking, have recently taken or may be taking any other medicines.
HEXTRIL 0.1 PERCENT Mouthwash, bottle with food and beverages
Not applicable.
Pregnancy and breast feeding
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
If you are breast-feeding, you should not use this medication.
Driving and using machines
HEXTRIL 0.1 PER CENT, mouthwash, vial has no or negligible effect on the ability to drive and use machines.
HEXTRIL 0.1 PER CENT, mouthwash, vial contains azo dye (Azorubine E122) and ethanol.
3. HOW TO USE HEXTRIL 0.1%, mouthwash, vial?
Always use this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS.
Administration mode
Local use in mouthwashes.
Rinse mouth or gargle for 30 seconds.
DO NOT swallow, but spit out after use.
Frequency of Administration
This solution for mouthwash is used pure or diluted: 1 dose 2 to 3 times a day.
Pur: pour HEXTRIL into the measuring cup up to the notch indicating 15 ml.
Diluted: in case of painful manifestations. Use the solution diluted to ½:
Pour HEXTRIL into the measuring cup up to the notch indicating 15 ml. Then fill with water to the top of the cup.
Rinse the measuring cup thoroughly after each use.
Duration of treatment
The duration of use is limited to 10 days.
If you used more than 0.1% HEXTRIL, mouthwash, bottle you should not have
Immediately consult your doctor or pharmacist.
Overdose is not expected under normal conditions of use. Certain constituents of this medication (essential oils) can lead to excessive doses, neurological accidents in the child (convulsions type) and in the elderly (agitation and confusion).
In case of epilepsy old or recent, ask your doctor for advice.
If you forget to take HEXTRIL 0.1 PER CENT, mouthwash, vial
Do not take a double dose to make up for a missed dose .
If you stop using HEXTRIL 0.1 PER CENT, mouthwash, vial
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Cases of allergic type reactions of the skin and mucous membranes, most commonly type of swelling of the face, neck, inflammation of the mouth have been reported with an indeterminate frequency (can not be estimated from the available data) .
Cases of local reactions such as irritation of the mouth or throat, tongue or tooth discoloration, lesions of the mucous membrane of the mouth have been reported with an indeterminate frequency (can not be estimated from of available data).
Due to the presence of terpene derivatives and in case of non-respect of the recommended doses:
· Convulsions in children and infants
· Possible agitation, confusion in the elderly
Declaration of side effects
If you experience any side effects, talk to 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: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE HEXTRIL 0.1 PER CENT, mouthwash, bottle?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25 ° C and keep the package in the outer carton.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What HEXTRIL contains 0,1 PER CENT, mouthwash, bottle
· The active substance is:
Hexétidine ................................................. .................................................. ................. 0.1000 g
For a 100 ml bottle.
· The other components are:
Polysorbate 60, sodium saccharin, methyl salicylate, clove essential oil, menthol, essential oil of anise, essential oil of peppermint, essential oil of eucalyptus, azorubine 85% (E 122), citric acid monohydrate, per cent, purified water.
What is HEXTRIL 0.1 PER CENT, Mouthwash, Bottle and contents of the pack
This medication is in the form of a mouthwash. Box of 1 bottle of 30, 200 or 400 ml.
Marketing Authorization Holder
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1 RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX
Marketing Authorization Operator
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1 RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX
Maker
FAMAR ORLEANS
5, AVENUE DE CONCYR
45071 ORLEANS
Names of the medicinal product 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]
Other
Detailed information on this medicine is available on the ANSM website (France).
