French pharmacy
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French pharmacy
COLLUDOL MOUTHWASH 30ML SORE THROAT is a drug that contains a local antiseptic and a local anesthetic. This drug is recommended in case of sore throat and low intensity without fever, mouth ulcers and small mouth sores.
COLLUDOL COLLUTOIRE 30ML SORE THROAT is a drug Colludol Collutoire 30 ml contains a local antiseptic and a local anesthetic. This medication is recommended for mild throat pain without fever, mouth ulcers and small mouth sores .
Method of administration : Oral spray.
Frequency of administration : It is imperative not to use this medication before meals or before drinking.
Sockets should be spaced at least 4 hours apart.
Duration of treatment : Treatment should not exceed 5 days without medical advice.
The active substances are :
Hexamidine diisethionate. 0.100 g
Lidocaine hydrochloride. 0.200 g
Per 100 ml of solution.
The other components are :
Glycerol, sucrose, passion fruit flavor, peach flavor, mint flavor, purified water.
Pressurization gas: nitrogen
Pressure: 7 bars
Special warnings
The anesthesia caused by this medication in the throat can encourage false routes (coughing during a meal with the impression of "swallowing crookedly") when swallowing food.
It is therefore imperative:
Prolonged use (more than 5 days) of this drug is not desirable because it can change the natural microbial balance of the mouth, throat.
Respect the indicated posology: taken in important quantity or in a repeated way, this drug while passing in the blood circulation, is likely to resound on the nervous system with possibility of convulsions and on the heart.
The use of this medication is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).
Precautions for use
This specialty should not be brought into contact with the eyes, introduced into the nose or the ears.
Sore throat :
In case of fever, purulent sputum (sputum), discomfort in swallowing food, as in worsening or lack of improvement after 5 days: consult your doctor.
Canker sores and small mouth sores
In case of extensive lesions, extension of lesions, onset of fever: consult your doctor immediately.
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per spray.
If in doubt, do not hesitate to seek the advice of your doctor or pharmacist.
30 ml pressurized bottle
Attention, the drug is not a product like the others. Read the package leaflet carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 27/06/2017
COLLUDOL, solution for buccal spraying in a pressurized bottle
Hexamidine diisthionate / Lidocaine hydrochloride
You should always use this medication exactly as prescribed by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your doctor or pharmacist for advice or information.
· If you experience any of the 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 5 days.
1. What is COLLUDOL, an oral spray solution in a pressurized vial and in which cases it is used?
2. What should I know before using COLLUDOL, an oral spray solution in a pressurized vial?
3. How to use COLLUDOL, oral spray solution in a pressurized vial?
4. What are the possible side effects?
5. How do I store COLLUDOL, an oral spray solution in a pressurized vial?
6. Package contents and other information.
1. WHAT COLLUDOL, solution for buccal spraying in a pressurized vial AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group: LOCAL ANTISEPTIC / LOCAL ANESTHESICS
(R: Respiratory system) - ATC code: R02AA20
This medicine contains a local antiseptic and a local anesthetic.
It is recommended in cases of sore throat with little intense and without fever, canker sores and small wounds of the mouth.
You should contact your doctor if you experience no improvement or feel less well after 5 days.
2. BEFORE YOU USE COLLUDOL, solution for buccal spraying in a pressurized vial?
Never use COLLUDOL, oral spray solution in pressurized vial:
· If you are allergic (hypersensitive) to the active ingredients or any of the other ingredients of this medication mentioned in section 6.
· If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
· In children under 6 years of age
· In case of a history of allergy to local anesthetics and hexamidine
Warnings and Precautions
Special warnings
Anesthesia caused by this drug in the throat can promote false roads (coughing during a meal with "swallowing") when swallowing food.
It is therefore imperative:
· To use this medicine only on medical advice in the child of 6 to 12 years,
· Do not use this medication before meals or before drinking.
Prolonged use (more than 5 days) of this medication is undesirable as it can alter the natural microbial balance of the mouth, throat.
Follow the recommended dosage: taken in large quantities or repeatedly, this medication while passing through the bloodstream, is likely to sound on the nervous system, with possibility of convulsions, and on the heart.
The use of this medication is not recommended in patients with fructose intolerance, glucose-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 into the ears.
Sore throat
In case of fever, sputum (sputum) purulent, discomfort with the swallowing of food, as in case of aggravation or lack of improvement after 5 days: CONSULT YOUR DOCTOR
Canker sores and small sores of the mouth
In case of extensive lesions, extensions of lesions, onset of fever: CONSULT YOUR DOCTOR IMMEDIATELY
This medication contains small amounts of ethanol (alcohol), less than 100 mg per spray.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
children
Not applicable.
Other medicines and COLLUDOL, solution for buccal spraying in a pressurized bottle
Do not use several medicines containing an antiseptic at the same time.
Inform your doctor or pharmacist if you are using, have recently used or could use any other medicines.
COLLUDOL, solution for buccal spraying in pressurized bottles with food and beverages
Not applicable.
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.
Driving and using machines
No effects on the ability to drive and use machines have been observed.
COLLUDOL, oral spray solution in pressurized vial contains sucrose and ethanol.
3. HOW TO USE COLLUDOL, solution for buccal spraying in a pressurized bottle?
Always use this medication exactly as prescribed in this leaflet or as directed by your doctor. your doctor or your pharmacist. Check with your doctor or pharmacist if you are unsure.
Dosage
Adult :
1 to 2 sprays 3 times a day
Do not exceed 2 sprays per dose and 3 times per day
Child from 6 to 15 years:
1 spray 1 to 3 times a day.
Do not exceed 1 spray per dose and 3 times per day.
Administration mode
Oral spraying
Frequency of Administration
It is imperative that you do not use this medication before meals or before drinking.
The catch must be spaced at least 4 hours apart.
Duration of treatment
Treatment should not exceed 5 days without medical advice
If you have used more COLLUDOL, an oral spray solution in a pressurized vial than you should have
Excessive application could lead to overdosage.
Symptoms of overdose include excitement, nervousness, drowsiness, nystagmus (dizziness), tinnitus (whistling in the ear), blurred vision, nausea, vomiting, convulsions, consciousness disorders. Other symptoms may include cardiac depression, vasodilatation (dilation of blood vessels), hypotension, arrhythmias (cardiac arrhythmias) and cardiac arrest.
Immediately consult your doctor or pharmacist.
If you forget to use COLLUDOL, solution for buccal spraying in a pressurized bottle
If you stop using COLLUDOL, oral spray solution in a pressurized 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.
· In case of redness, swelling of the face and throat: in this case stop treatment immediately and consult your doctor.
· Transient numbness of the tongue.
· In the event of a false route (cough during a meal with "swallowing") it is advisable to discontinue the treatment and seek the advice of a doctor.
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 COLLUDOL, solution for buccal spraying in a pressurized 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.
Pressurized container:
· Do not expose to temperatures above 50 ° C or to the sun
· Do not drill,
· Do not throw into the fire even empty.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
Do not use this medication if you notice signs of visible signs of deterioration.
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 COLLUDOL contains, an oral spray solution in a pressurized vial
· The active substances are:
Hexamidine diisodethionate .............................................. ............................................... 0.100 g
Lidocaine hydrochloride ............................................... ................................................ 0.200 g
For 100 ml of solution.
· Other ingredients are: Glycerol, sucrose, passion fruit flavor, peach aroma, mint flavor, purified water.
Pressurization gas: nitrogen
Pressure: 7 bars
What is COLLUDOL, solution for buccal spraying in a pressurized vial and contents of the pack
This medication is in the form of a solution for oral spraying.
Bottle of 30 ml.
Marketing Authorization Holder
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Marketing Authorization Operator
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
AREA OF ACTIVITY THE COUNTY
ROUTE DE GOUISE
03340 BESSAY SUR ALLIER
or
SOCIETE DE PRODUCTION PHARMACEUTIQUE AND HYGIENE-SPPH
7 IMPASSE OF BOUSSENOTS
21800 QUETIGNY LES DIJON
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:
June 2017
Detailed information on this medicine is available on the ANSM website (France).
Antiseptic and analgesic mouthwash
hexamidine, lidocaine
. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
COLLUDOL: solution for oral spraying (flavors: passion fruit, peach); pressurized 30 ml bottle.
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French Pharmaceutical Cooperation Laboratory
| p 100 ml | |
| Hexamidine di-isétionate | 100 mg |
| Lidocaine hydrochloride | 200 mg |
| Mint, gasoline | + |
Usual dosage:
