In this manual :
1. WHAT IS HEXASPRAY, pressurised mouthwash and WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE USING HEXASPRAY, pressurised mouthwash bottle?
3. HOW DO I USE HEXASPRAY, pressurised mouthwash bottle?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE HEXASPRAY, pressurised mouthwash bottle?
6. ADDITIONAL INFORMATION
1. WHAT IS HEXASPRAY, pressurised mouthwash and WHAT IS IT USED FOR?
Pharmacotherapeutic class
Local antiseptic.
This medicine is indicated for the local adjunctive treatment of mild sore throats without fever.
2. WHAT YOU SHOULD KNOW BEFORE USING HEXASPRAY, pressurised mouthwash?
List of information needed before taking the medicine
Not applicable.
Never use HEXASPRAY, pressurised mouthwash in the following cases:
- If you have a history of allergy to any of the components of the mouthwash.
- Pressurised mouthwashes are contraindicated in infants (risk of laryngospasm).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Take care with HEXASPRAY, mouthwash in pressurised bottle:
Special warnings
DO NOT LEAVE THIS MEDICINE WITHIN THE REACH OF CHILDREN.
Prolonged use (more than 5 days) is not desirable, as it may alter the natural microbial balance of the throat.
The simultaneous or successive use of antiseptics should be avoided because of possible interference (antagonism, inactivation).
Precautions for use
In the event of fever, purulent sputum, discomfort when swallowing food, or if the condition worsens or does not improve within 5 days: CONSULT YOUR DOCTOR.
Interactions with other medicines
Taking or using other drugs
This medicine contains biclotymol. Other medicines contain biclotymol; do not combine them, so as not to exceed the maximum recommended doses (see Dosage, Directions for Use).
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breastfeeding
Pregnancy
|
Do not take this medicine without asking your doctor or pharmacist.
|
As a precautionary measure, biclotymol should not be used during pregnancy.
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: methyl parahydroxybenzoate (E218).
3. HOW TO USE HEXASPRAY, pressurised mouthwash bottle?
Instructions for proper use
Not applicable.
Dosage, method and/or route of administration, frequency of administration and duration of treatment
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 30 MONTHS.
2 sprays, 3 times a day.
Method of administration
Oral use.
|
SHAKE BEFORE EACH USE.
To spray, simply rotate the stem of the nozzle a quarter turn SPRAY HOLDING THE BOTTLE UP.
|
Duration of treatment
Treatment should not exceed 5 days.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, HEXASPRAY, pressurised mouthwash is likely to have adverse reactions, although not everyone is subject to them:
- Possible allergic manifestations: lip edema, urticaria, skin rashes, erythema, angioedema.
- The presence of methyl parahydroxybenzoate (E218) and soy lecithin may cause allergic reactions.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO CONSERVE HEXASPRAY, pressurised mouthwash bottle?
Keep out of the reach and sight of children.
Do not use HEXASPRAY, pressurised mouthwash after the expiry date stated on the bottle.
Do not expose to heat.
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 HEXASPRAY, mouthwash in pressurised bottle, contain?
The active substance is:
Biclotymol ....................................................................................................................................... 750 mg
Per 30 g.
The other components are:
Benzyl alcohol, disodium edetate, methyl parahydroxybenzoate, reconstituted aniseed essential oil, ammonium glycyrrhizinate, sodium saccharin, dispersible cellulose, soya lecithin, glycerol, 96% ethanol, purified water, nitrogen.
Pharmaceutical form and contents
What is HEXASPRAY, mouthwash in pressurised bottle and what does it contain?
This medicine is in the form of a mouthwash.
Pressurised bottle of 8, 10, 15, 20 or 30 g.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
BOUCHARA RECORDATI
68, RUE MARJOLIN
BP 67
92302 LEVALLOIS-PERRET CEDEX
Operator
LABORATOIRES BOUCHARA RECORDATI
68, RUE MARJOLIN
92300 LEVALLOIS-PERRET
Manufacturer
LABORATOIRES BOUCHARA RECORDATI
PARC MECATRONIC
03410 SAINT VICTOR
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet 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.
Français
English
