HEXTRIL 0.1% MOUTH SOLUTION BATH 400 ML

HEXTRIL 0,1% BAIN BOUCHE SOLUTION 400 ML View larger

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For warnings, the precautions and cons-indications, please see the instructions.

Description

Bath Hextril antiseptic mouth is a drug indicated for the local side of the affections of the mouth treatment. Treatment of sore mouth ulcers and sore gums.

From 6 years
Flavors available:   mint or classic taste

Composition:

  • Hexetidine
  • Excipients mint flavor   : Quinoline yellow, patent blue V, purified water, polysorbate 60, sodium saccharin, 96% ethanol, citric acid monohydrate, mint flavor 12202-34.
  • Excipients classic Hextril   Polysorbate 60, sodium saccharin, methyl salicylate, clove oil, menthol, essential oil of anise, peppermint, eucalyptus, azorubine 85% (E 122), citric acid monohydrate, 96% ethanol, water purified.
  • Excipients with known effect   Ethanol, azorubine

Instructions:   Pure or diluted use, 2 or 3 rinses a day.

  • Pur: pour the solution into the bucket until the slot divider indicating 15ml.
  • Diluted: in case of occurrence of painful events, use diluted 1/2 solution, pour the solution until the notch indicating 15ml and complete with water up to the top of the bucket

Cons-indications:

  • Hypersensitivity to a component

Contents:   200 or 400ml

Warnings on drugs

Warning, the drug is not a product like any other. Read the package leaflet before ordering. Do not leave medicines out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Attention to incompatibilities on products in your.

Tell your pharmacist online treatments underway to identify possible incompatibilities. The checkout form contains a custom message field provided for this purpose.

Click here to find record of the drug at the site of the National Security Agency of Medicines and Health Products.

Pharmacovigilance : Report or a related adverse event (s) (s) (s) the use of a drug

VIDAL OF THE FAMILY

HEXTRIL Mouthwash

Antiseptic mouthwash

hexetidine

. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

HEXTRIL 0,1%: solution for mouthwash ; 200 ml bottle with 15 ml measuring cup.
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HEXTRIL 0,1%: solution for mouthwash ; 400 ml bottle with 15 ml measuring cup.
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HEXTRIL MINT 0.1%: solution for mouthwash ; 200 ml bottle with measuring cup graduated to 15 ml.
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HEXTRIL MINT 0.1%: solution for mouthwash ; 400 ml bottle with measuring cup graduated to 15 ml.
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Laboratory

COMPOSITION (summary)
p 100 ml
hexetidine 100 mg
96 ° Alcohol +
Menthol +

INDICATIONS (summary)
This mouthwash solution contains an antiseptic .
It is used in the adjuvant treatment of the affections of the mouth or the suites of operation of the gums or the teeth.
CONTRAINDICATIONS (summary)
This medication should not be used in children younger than 6 years of age.
WARNING (Contents)
This medicinal product contains terpenes (presence of menthol) which, if the dosage is exceeded, can cause serious adverse effects: adhere to recommended doses, especially in children or in cases of epilepsy .
Prolonged use of local antiseptic treatments ( gargle , mouthwash , lozenge) is undesirable; it can alter the natural microbial balance of the throat.
If there is no improvement after 5 days, consult your doctor.
PREGNANCY AND BREAST-FEEDING (summary)
The effect of this medication during pregnancy or lactation is not well known. The assessment of the possible risk associated with its use is individual: ask your pharmacist or doctor for advice.
DIRECTIONS FOR USE AND DOSAGE (summary)
The solution can be used pure or diluted to half if it appears a painful sensation. To obtain a half dilution, pour the solution to the first stroke of the cup and top up with water.
For each mouthwash , use the contents of a measuring cup. The solution is kept in the mouth for about 1 minute before being spat out. It should not be swallowed.

Usual dosage:

  • Adult and child over 6 years: 2 or 3 mouthwashes per day.
TIPS (summary)
This medicinal product may be freely available in certain pharmacies; nevertheless, do not hesitate to ask your pharmacist for advice.
Avoid eating or drinking within one hour of the mouthwash .
Some dentists and stomatologists do not recommend mouthwashing within hours of dental extraction to avoid bleeding the wound.
POSSIBLE ADVERSE EFFECTS (summary)
Allergic reaction .
Due to the presence of terpenes (menthol) and if the usual dosage is exceeded: risk of convulsions in children and agitation and confusion in the elderly.


GLOSSARY (summary)


antiseptic
A substance that locally destroys bacteria, reducing their numbers and preventing their proliferation. Some antiseptics are also active on microscopic fungi and viruses.


mouthwash
A local treatment method which consists in leaving on the contact of lesions of the mouth or the gums a medicine pure or diluted in cold or lukewarm water.


mouthwash
Medication that acts by contact on the throat and internal walls of the mouth. It is administered by spraying or brushing.


convulsions
Involuntary contractions limited to a few muscles or generalized to the whole body. They are due to excessive pain or stimulation of the brain: fever, poisoning, lack of oxygen, brain damage. Convulsions may be due to an epileptic seizure or high fever in young children.


epilepsy
A chronic seizure disorder associated with abnormal electrical activity of a group of brain cells. Its manifestations, varying in intensity, range from the sudden drop in attention (absences, or small evil) to loss of consciousness accompanied by abnormal muscle movements (convulsions, or great evil). Partial epilepsy, as its name implies, does not concern the whole body: the jerky movements only touch one or more muscle groups.


gargle
A method of local treatment which aims to leave in contact with the throat a drug pure or diluted in cold or lukewarm water. The head is tilted backwards, a continuous exhalation preventing the liquid from descending into the lungs. The solution used must not be swallowed.


dosages
Quantity and distribution of the dose of a drug according to the age, weight and general condition of the patient.


Allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


terpenes
A general term for aromatic substances of vegetable origin. These are traditionally used for their respiratory properties (stimulating, expectorant, antiseptic) and their revulsive power when applied to the skin. The most used are camphor, menthol, eucalyptol, essential oils of mint, turpentine, niaouli, pine, anise, etc.
Some terpenes, and especially camphor, have been responsible for convulsions, respiratory pauses in the infant, in case of overdose. They can also cause behavioral problems in the elderly. These products should be used with caution at the extreme ages of life.


treatment
Treatment that complements the action of a specific treatment, but generally does not achieve healing on its own.

Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.

Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

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).

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