NOTICE
ANSM - Updated on : 07/12/2018
Product name
HEXASPRAY, mouthwash in pressurized bottle
Biclotymol
Box
Please read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as it is described in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- 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 do not feel any improvement or if you feel less well after 5 days.
What does this leaflet contain?
1. What is HEXASPRAY, mouth spray in pressurized bottle, and what is it used for?
2. What do I need to know before using HEXASPRAY, pressurized Mouth Spray?
3. How do I use HEXASPRAY, Mouth Spray?
4. What are the possible side effects?
5. How to store HEXASPRAY, pressurized mouthwash bottle?
6. Package contents and other information.
1. WHAT IS HEXASPRAY, Mouth Spray in Pressurized Bottle AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Local antibacterial drug - ATC code: R02AA19.
Antibacterial activity against Gram+ bacteria under the following conditions: 15-minute contact time at maximum concentration (90%).
Therapeutic indications
This medication is indicated for the local treatment of mild sore throats without fever.
You should consult your doctor if you do not feel any improvement or if you feel worse after 5 days.
2. WHAT DO I HAVE TO KNOW BEFORE USING HEXASPRAY, Mouth Spray in pressurized bottle?
Never use HEXASPRAY, mouthwash in pressurized bottle:
- If you have a history of allergy to any of the components of the mouthwash.
- Pressurized mouthwashes are contraindicated in infants (risk of laryngospasm).
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST.
Warnings and precautions
Special warnings
KEEP OUT OF REACH OF CHILDREN.
Prolonged use (more than 5 days) is undesirable, as it may alter the natural microbial balance of the throat.
The simultaneous or successive use of antiseptics with biclotymol should be avoided in view of possible interference (antagonism, inactivation).
This medicine contains methyl parahydroxybenzoate and may cause allergic reactions with urticaria and respiratory discomfort.
This medicine contains 35 mg benzyl alcohol per dose (2 sprays). Benzyl alcohol may cause allergic reactions and mild local irritation.
This medicine contains less than 1 mmol (23 mg) sodium per spray, i.e. it is essentially "sodium-free".
Precautions for use
In the event of fever, purulent sputum or difficulty swallowing food, or if the condition worsens or does not improve within 5 days: CONSULT YOUR PHYSICIAN.
Children and teenagers
Not applicable.
Other medicinal products and HEXASPRAY, mouthwash in pressurized bottle
This medicine contains biclotymol. Other medicines contain biclotymol; do not combine them, so as not to exceed the maximum recommended doses .
HEXASPRAY, pressurized mouthwash, with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
Do not take this medicine without consulting your doctor or pharmacist.
As a precautionary measure, biclotymol should not be used during pregnancy or while breast-feeding.
Ask your doctor or pharmacist for advice before taking any medication.
Driving and use of machinery
Not applicable.
HEXASPRAY, mouthwash in pressurized bottle, contains methyl parahydroxybenzoate (E218) and benzyl alcohol.
3. HOW TO USE HEXASPRAY, pressurized mouthwash?
Always use this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
FOR ADULTS AND CHILDREN OVER 30 MONTHS.
The recommended dose is 2 sprays, 3 times a day.
Method of administration
Take orally.
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SHAKE BEFORE EACH USE.
To spray, simply rotate the nozzle stem a quarter-turn. SPRAY WHILE HOLDING BOTTLE UP.
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Duration of treatment
Treatment should not exceed 5 days.
If you have used more HEXASPRAY, Mouth Spray in Pressurized Bottle than you should have:
Not applicable.
If you forget to use HEXASPRAY, mouthwash in pressurized bottle :
Not applicable.
If you stop using HEXASPRAY, Mouth Spray in Pressurized Bottle :
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Undesirable effects are listed below, in order of frequency:
Very rare (affecting up to 1 in 10,000 people): swelling of the lips, urticaria, rash, erythema, angioedema.
The presence of methyl parahydroxybenzoate (E218) may cause allergic reactions.
Reporting side effects
If you experience any side effects, please tell 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: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website:
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW SHOULD HEXASPRAY be used?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging or bottle.
The expiration date refers to the last day of that month.
Do not expose to heat.
Do not dispose of any medicine in the garbage. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What HEXASPRAY mouthwash in pressurized bottle contains
- The active substance is :
- Biclotymol .750 mg
For 30g.
- The other components are :
Benzyl alcohol, edetate disodium, methyl parahydroxybenzoate, star anise essential oil, dammonium glycyrrhizinate, saccharin sodium, dispersible cellulose, soya lecithin, glycerol, 96% ethanol, purified water, nitrogen.
Notable excipients: methyl parahydroxybenzoate (E218).
What HEXASPRAY is and what it contains
This medicine comes in a pressurized bottle of 8, 10, 15, 20 or 30 g.
Not all presentations may be marketed.
Marketing authorization holder
BOUCHARA-RECORDATI
70 AVENUE DU GENERAL DE GAULLE
IMMEUBLE LE WILSON
92800 PUTEAUX
FRANCE
Marketing authorization holder
LABORATOIRES BOUCHARA-RECORDATI
70 AVENUE DU GENERAL DE GAULLE
IMMEUBLE LE WILSON
92800 PUTEAUX
FRANCE
Manufacturer
LABORATOIRES BOUCHARA-RECORDATI
PARC MECATRONIC
03410 SAINT VICTOR
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
November 2018.
Other
Not applicable.