Colludol mouth spray 30ml

Name of the medicinal product

COLLUDOL, solution for oral spray in pressurized bottle

Hexamidine diisethionate/Lidocaine hydrochloride

Boxed

Please read this leaflet carefully before taking this medicine. It contains important information for your treatment.

If you have any further questions, ask your doctor or pharmacist for more information.

Keep this leaflet as you may need to read it again.

If you need more information and advice, ask your pharmacist.

If symptoms worsen or persist, consult your doctor.

If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.

Leaflet summary

In this leaflet :

1. WHAT IS COLLUDOL, solution for oral spray in pressurised bottle AND WHAT IS IT USED FOR?

2. WHAT DO YOU NEED TO KNOW BEFORE USING COLLUDOL, solution for oral spray in pressurised bottle?

3. HOW DO I USE COLLUDOL, solution for mouth spray in a pressurised bottle?

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

5. HOW TO USE COLLUDOL, solution for mouth spray in pressurised bottle?

6. ADDITIONAL INFORMATION

1. WHAT IS COLLUDOL, solution for oral spray in pressurised bottle AND WHAT IS IT USED FOR?

Pharmacotherapeutic class

LOCAL ANTISEPTIC/LOCAL ANESTHETIC

(R: Respiratory system).

Therapeutic indications

This medicine contains a local antiseptic and a local anaesthetic.

This medicine is recommended in cases of mild sore throat without fever, mouth ulcers and small sores of the mouth.

2. WHAT YOU SHOULD KNOW BEFORE USING COLLUDOL, solution for mouth spray in pressurised bottle

List of information needed before taking the medicine

If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.

Contraindications

Never use COLLUDOL, solution for oral spray in pressurized bottle in the following cases:

Children under 6 years of age.

If you have a history of allergy to local anaesthetics and hexamidine.

IN CASE OF DOUBT, IT IS ESSENTIAL TO SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.

Precautions for use; special warnings

Take care with COLLUDOL, solution for mouth spray in pressurised bottle:

Special warnings

The anaesthesia caused by this medicine in the throat may favour false routes (coughing during a meal with the impression of "swallowing wrong") when swallowing food.

It is therefore imperative:

Donot use this medicine for children between 6 and 12 years of age unless directed by a doctor,

Donot use this medicine before meals or drinks.

Prolonged use (more than 5 days) of this medicine is not desirable because it may alter the natural microbial balance of the mouth and throat.

Respect the indicated dosage: taken in large quantities or repeatedly, this medicine, by passing into the bloodstream, is likely to affect the nervous system with the possibility of convulsions and the heart.

The use of this medicine is not recommended in patients with fructose intolerance, glucose and galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases).

Precautions for use

This specialty should not be put in contact with the eyes, introduced into the nose or ears.

Sore throat:

In the event of the occurrence of fever, purulent sputum (sputum), discomfort in swallowing food, as in the event of aggravation or lack of improvement after 5 days: CONSULT YOUR DOCTOR.

Mouth ulcers and small sores

In case of extensive lesions, extension of lesions, appearance of fever: CONSULT YOUR DOCTOR IMMEDIATELY.

This medicine contains small amounts of ethanol (alcohol), less than 100 mg per spray.

IF IN DOUBT, SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.

Interactions with other medicines

Taking or using other medicines:

Do not use more than one medicine containing an antiseptic at the same time.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medication, even if it is obtained without a prescription.

Interactions with food and drink

Not applicable.

Interactions with herbal products or alternative therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and lactation

This medicine should be used with caution during pregnancy and breastfeeding. In general, you should seek advice from your doctor or pharmacist before taking any medicine.

Sportsmen

The attention of sportsmen and women should be drawn to the fact that this medicinal product contains an active ingredient (lidocaine, a local anaesthetic) which may cause a positive reaction in tests carried out during anti-doping controls.

Effects on the ability to drive vehicles or use machines

Driving and use of machinery:

No effect on the ability to drive vehicles and use machines has been observed.

List of excipients with a known effect

List of excipients with a notorious effect:

Sucrose, ethanol.

3. HOW TO USE COLLUDOL, oral spray solution in pressurised bottle

Instructions for proper use

Not applicable.

Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment

Dosage

Adults:

-1 to 2 sprays 3 times a day.
Do not exceed the dose of 2 sprays per dose and 3 doses per day.

Children 6 to 15 years:

-1 spray 1 to 3 times a day.
Do not exceed the dose of 1 spray per intake and 3 intakes per day.

Method of administration

Oral spray.

Frequency of administration

It is imperative not to use this medicine before meals or before drinking.

The doses should be taken at least 4 hours apart.

Duration of treatment

Treatment should not exceed 5 days without medical advice.

Symptoms and instructions in case of overdose

If you have used more COLLUDOL, Oral Spray Solution in a pressurised bottle than you should have, you should not take more than the recommended dose:

Over-application could lead to an overdose.

Symptoms of overdose include excitement, nervousness, drowsiness, nystagmus (dizziness), tinnitus (ringing in the ear), blurred vision, nausea, vomiting, convulsions, and confusion. Other symptoms may include heart depression, vasodilation (dilation of blood vessels), low blood pressure, arrhythmias (heart rhythm disturbances), and cardiac arrest.

Consult your doctor or pharmacist immediately.

Instructions in case of missed doses

Not applicable.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Description of side effects

Like all medicines, COLLUDOL, oral spray solution in pressurised bottle is likely to have adverse reactions, although not everyone is subject to them:

Occurrence of redness, swelling of the face and throat: in this case stop the treatment immediately and consult your doctor.

Temporary numbness of the tongue.

In the event of a false start (coughing during a meal with the impression of "swallowing the wrong way"), it is advisable to interrupt the treatment and seek medical advice.

If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.

5. HOW TO STORE COLLUDOL, solution for mouth spray in pressurised bottle

Keep out of the reach and sight of children.

Expiry date

Do not use COLLUDOL, solution for oral spray in pressurised bottle after the expiry date stated on the outer packaging.

Storage conditions

Pressurised container:

Do not expose to temperatures above 50°C or to sunlight,

Do not pierce,

do not dispose of in fire, even if empty.

If necessary, warnings against certain visible signs of deterioration

Medicines must not be disposed of in the sewage system or with household waste. Ask your pharmacist what to do with unused medicines. This will help protect the environment.

6. ADDITIONAL INFORMATION

Full list of active ingredients and excipients

What does COLLUDOL oral spray solution in pressurised bottle contain?

The active ingredients are:

Hexamidine diisethionate ................................................................................................................ 0.100 g

Lidocaine hydrochloride .................................................................................................................. 0.200 g

For 100 ml of solution.

The other components are:

Glycerol, sucrose, passion fruit flavor, peach flavor, mint flavor, purified water.

Pressurization gas: nitrogen

Pressure: 7 bar

Pharmaceutical form and content

What is COLLUDOL, solution for oral spray in pressurised bottle and what does it contain?

This medicinal product is presented as a solution for mouth spray.

Bottle of 30 ml.

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

Holder

COOPERATION PHARMACEUTIQUE FRANCAISE

PLACE LUCIEN-AUVERT

77020 MELUN CEDEX

Operator

LABORATOIRES COOPERATION PHARMACEUTIQUE FRANCAISE

PLACE LUCIEN AUVERT

77020 MELUN CEDEX

Manufacturer

CREAPHARM BESSAY SAS

ZONE D'ACTIVITE LE COMTE

ROUTE DE GOUISE

03340 BESSAY SUR ALLIER

or

SOCIETE DE PRODUCTION PHARMACEUTIQUE ET D'HYGIÈNE (SPPH)

7, IMPASSE DES BOUSSENOTS

21800 QUETIGNY