NOTICE
ANSM - Updated on : 04/04/2023
Product name
SEDACOLLYRE CETHEXONIUM 0.25 per thousand, eye drops solution
Cethexonium bromide
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 advice and information.
- 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 15 days.
What does this leaflet contain?
1. What is SEDACOLLYRE CETHEXONIUM 0.25 per thousand, eye drops solution and what is it used for?
2. What do I need to know before using SEDACOLLYRE CETHEXONIUM 0.25 per thousand, eye drops solution?
3. How do I use SEDACOLLYRE CETHEXONIUM 0.25 per thousand, eye drops solution?
4. What are the possible side effects?
5. How should SEDACOLLYRE CETHEXONIUM 0.25 per thousand eye drops be stored?
6. Package contents and other information.
1. WHAT IS SEDACOLLYRE CETHEXONIUM 0.25 per thousand, eye drops solution AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: LOCAL ANTISEPTIC (S = sense organ) - ATC code: S01AX
Antiseptic treatment of superficial disorders of the eye and its appendages.
2. WHAT DO I HAVE TO KNOW BEFORE USING SEDACOLLYRE CETHEXONIUM 0.25 per thousand, eye drops solution?
Never use SEDACOLLYRE CETHEXONIUM 0.25 per thousand, eye drops solution:
- if you are allergic to certain antiseptics (quaternary ammoniums).
Warnings and precautions
Talk to your doctor or pharmacist before using SEDACOLLYRE CETHEXONIUM 0.25 pour mille, collyre en solution.
Use this medicine with care:
- do not touch the eye with the tip of the bottle,
- avoid use in contact lens wearers, who run a greater risk of local intolerance,
- follow the recommended dosage and do not prolong treatment beyond 15 days; close the bottle carefully after use,
- in the event of concomitant treatment with another eye drop, wait at least 15 minutes between each instillation.
If in doubt, ask your doctor or pharmacist.
Children
Other medicines and SEDACOLLYRE CETHEXONIUM 0.25 per thousand, eye drops solution
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines, in order to avoid possible drug interactions, especially with other ocular antiseptics.
SEDACOLLYRE CETHEXONIUM 0.25 per thousand, eye drops with food, drink and alcohol.
Not applicable.
Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this eye drop.
Under normal conditions of use, this medicine may be used during pregnancy and breast-feeding.
Driving vehicles and operating machinery
Temporary visual discomfort may be experienced after instillation. In this case, it is advisable not to drive or operate machinery until vision returns to normal.
SEDACOLLYRE CETHEXONIUM 0.25 per thousand, eye drops contains sodium chloride and water for injection.
3. HOW TO USE SEDACOLLYRE CETHEXONIUM 0.25 per thousand, eye drops solution?
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.
Instill 1 drop into the eye 3 to 4 times a day.
Local use.
FOR EYE INSTILLATION
Looking upwards and pulling the lower eyelid slightly downwards, instill 1 drop into the eye 3 to 4 times a day for 7 days.
TO USE THE BOTTLE: Screw the cap on tightly to pierce the mouthpiece.
After use, close the bottle and put it back in its box.
Be careful not to touch the eye with the tip of the bottle.
DURATION OF TREATMENT: Average 7 days. Do not prolong treatment beyond 15 days.
If you have used more SEDACOLLYRE CETHEXONIUM 0.25 per thousand, eye drops solution than you should have
Rinse with sterile saline solution.
If you forget to use SEDACOLLYRE CETHEXONIUM 0.25 per thousand, eye drops solution
Not applicable.
If you stop using SEDACOLLYRE CETHEXONIUM 0.25 per thousand, eye drops solution
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 product may cause undesirable effects, but they do not occur systematically in everyone.
A local intolerance reaction may occur. In the event of the appearance of abnormal symptoms (redness and/or pain in the eye), discontinue treatment and consult your doctor.
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 Regional Pharmacovigilance Centers.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO USE SEDACOLLYRE CETHEXONIUM 0.25 per thousand, eye drops solution?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the EXP bottle.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What SEDACOLLYRE CETHEXONIUM 0.25 per thousand eye drops solution contains
- The active substance is :
Cethexonium bromide................................................................................................ 0.025 g
per 100 mL.
- Other ingredients are sodium chloride and water for injection.
What SEDACOLLYRE CETHEXONIUM 0.25 per thousand is and what it contains
This medicine is available as an eye drop in 10 mL bottles.
Marketing authorization holder
COOPÉRATION PHARMACEUTIQUE FRANÇAISE
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Marketing authorization holder
COOPÉRATION PHARMACEUTIQUE FRANÇAISE
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Manufacturer
EXCELVISION
RUE DE LA LOMBARDIÈRE
07100 ANNONAY
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Not applicable.
Detailed information on this drug is available on the ANSM (France) website.