HEXASPRAY SORE THROAT EXOTIC FRUITS PRESSURIZED BOTTLE 30G

1. WHAT IS HEXASPRAY EXOTIC FRUIT, pressurised mouthwash and WHAT IS IT USED FOR?

Pharmacotherapeutic class

Antibacterial activity against Gram+ bacteria under the following conditions: contact time of 15 minutes at maximum concentration (90%).

Therapeutic indications

This medicine is indicated for adults and children over 6 years of age in case of mild sore throat without fever.

2. WHAT YOU SHOULD KNOW BEFORE USING HEXASPRAY EXOTIC FRUITS, pressurised mouthwash bottle

List of information necessary before taking the medicine

Not applicable.

Contraindications

Never use HEXASPRAY EXOTIC FRUITS, mouthwash in pressurised bottle:

If you are allergic (hypersensitive) to the active substance or to any of the other components contained in this medicine, mentioned in section 6.

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

Warnings and precautions for use

Take care with HEXASPRAY exotic fruits, pressurized bottle:

Warnings

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 with biclotymol should be avoided because of possible interference (antagonism, inactivation).

The presence of soya lecithin may cause allergic reactions.

Precautions for use

In case of fever, purulent sputum, discomfort when swallowing food and in case of aggravation or lack of improvement after 5 days: CONSULT YOUR DOCTOR.

Interactions with other medicines

Other medicinal products and HEXASPRAY EXOTIC FRUITS, pressurised mouthwash bottle

This medicine contains biclotymol. Other medicines contain it. Do not combine them, so as not to exceed the maximum recommended doses (see section 3 "How to use HEXASPRAY EXOTIC FRUITS, Mouth Spray").

Interactions with food and drink

Not applicable.

Interactions with herbal products or alternative therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy, breastfeeding and fertility

As a precautionary measure, biclotymol should not be used during pregnancy.

Ask your doctor or pharmacist for advice before taking any medicine.

Sportsmen

Not applicable.

Effects on ability to drive and use machines

Not applicable.

List of excipients with a known effect

HEXASPRAY EXOTIC FRUITS, mouthwash in pressurised bottle contains soya lecithin.

3. HOW TO USE HEXASPRAY EXOTIC FRUIT, pressurised 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.

2 sprays 3 times a day.

Mode of administration

Oral use.

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, this drug may cause side effects, but they do not always occur in everyone.

The following side effects may occur during treatment:

Very rare side effects (may occur in up to 1 in 10,000 people):

Lip edema, urticaria, rash, erythema (redness), angioedema (or angioedema: a severe reaction involving sudden swelling of the face, lips, tongue and/or larynx causing difficulty in breathing or swallowing)

Undesirable effects of undetermined frequency:

Hypersensitivity (allergy) to biclotymol or to another component such as soy lecithin

Side effect reporting

If you experience any side effects, talk to your doctor, pharmacist or nurse. 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 Regional Pharmacovigilance Centres - Website: www.ansm.sante.fr

By reporting adverse reactions, you are helping to provide more information about the safety of the medicine.

5. HOW TO CONSERVE HEXASPRAY EXOTIC FRUITS, pressurised mouthwash bottle?

Keep out of sight and reach of children.

Expiry date

Do not use this medicine after the date stated on the outer packaging. The expiry date refers to the last day of that month.

Storage conditions

Do not expose to heat.

If necessary, warnings against certain visible signs of deterioration

Do not dispose of any medication down the drain or in the household garbage. Ask your pharmacist to dispose of any medication you no longer use. This will help protect the environment.

6. ADDITIONAL INFORMATION

Full list of active ingredients and excipients

What HEXASPRAY EXOTIC FRUITS contains: Mouthwash in pressurised bottle

The active substance is:

Biclotymol ..................2.500 g

For 100 g of mouthwash.

The other components are:

Benzyl alcohol, edetate disodium, tropical flavour, ammonium glycyrrhizinate, saccharin sodium, dispersible cellulose, soya lecithin, glycerol, ethanol 96%, purified water, nitrogen (propellant).

Pharmaceutical form and content

What HEXASPRAY EXOTIC FRUITS looks like and what it contains

This medicine is in the form of a mouthwash. Pressurised bottle of 15 or 30 g.

Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different

Marketing authorisation holder and manufacturer

Holder

BOUCHARA-RECORDATI

IMMEUBLE LE WILSON

70 AVENUE DU GENERAL DE GAULLE

92800 PUTEAUX