NOTICE
ANSM - Updated on : 06/09/2021
Product name
OPTICRON 2 PER CENT, eye drops
Sodium cromoglycate
Box
Please read this leaflet carefully before using this medicine, as it contains important information for you.
You must always use this medicine in strict accordance with the information given in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- 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.
What does this leaflet contain?
1. What is OPTICRON 2 PER CENT, eye drops and what is it used for?
2. What do I need to know before using OPTICRON 2 PER CENT, eye drops?
3. How should OPTICRON 2 PER CENT eye drops be used?
4. What are the possible side effects?
5. How should OPTICRON 2 PER CENT eye drops be stored?
6. Package contents and other information.
1. WHAT IS OPTICRON 2 PER CENT, eye drops AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: ANTI-ALLERGIC (S = sensory organ).
Thisophthalmic solution is indicated in cases of allergic eye disease (allergic conjunctivitis).
2. WHAT DO I HAVE TO KNOW BEFORE USING OPTICRON 2 PER CENT, eye drops?
Never use OPTICRON 2 PER CENT, eye drops:
- If you have a history of allergy to any of the components of the eye drops.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST.
Warnings and precautions
Ask your doctor or pharmacist before using OPTICRON 2 PER CENT, eye drops.
KEEP OUT OF THE REACH OF CHILDREN.
DO NOT INJECT, DO NOT SWALLOW.
Do not exceed recommended dosage.
If symptoms persist or fail to improve, seek medical advice.
In case of concomitant treatment with another eye drop, wait 15 minutes between each instillation.
Recap bottle after use.
Due to the presence of benzalkonium chloride, this medicine may cause eye irritation.
Avoid contact with soft contact lenses. Remove contact lenses before application and wait at least 15 minutes before reinserting them.
Benzalkonium chloride may discolor soft contact lenses.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST.
Children
Not applicable.
Other drugs and OPTICRON 2 PER CENT, eye drops
In case of concomitant treatment with another eye drop, wait 15 minutes between each instillation.
Tell your doctor or pharmacist if you are using, have recently used or may use any other medicines.
OPTICRON 2 PER CENT, eye drops with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
OPTICRON 2 PER CENT, eye drops pass minimally into the systemic circulation, and may be used during pregnancy and lactation.
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 taking this medicine.
Driving and using machines
Temporary visual discomfort may be experienced after instilling eye drops.
In this case, wait until the symptoms have ceased before driving or operating machinery.
OPTICRON 2 PER CENT, eye drops contains benzalkonium chloride.
3. HOW DO I USE OPTICRON 2 PER CENT, eye drops?
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.
Dosage
- Adults and children: depending on the severity of symptoms, instill 1 drop into each ear, 2 to 6 times a day, at regular intervals.
- For children, medical advice is required.
- Do not exceed the recommended dosage.
IN ALL CASES, COMPLY STRICTLY WITH YOUR DOCTOR'S PRESCRIPTION.
Method and route of administration
Local use.
FOR OCULAR INSTILLATION.
Wash your hands thoroughly before instilling.
Instill 1 drop of eye drops into the conjunctival cul de sac of the diseased eye, looking upwards, pulling the eyelid slightly downwards and avoiding contact of the tip with the eye or eyelids.
Recap the bottle after use.
Frequency of administration
In case of concomitant treatment with another eye drop, wait 15 minutes between each instillation.
Duration of treatment
Do not prolong treatment without medical advice.
If symptoms persist or fail to improve, seek medical advice.
If you have used more OPTICRON 2 PER CENT, eye drops than you should have
In case of overdose, rinse with sterile saline solution.
If you forget to use OPTICRON 2 PER CENT, eye drops
Not applicable.
If you stop using OPTICRON 2 PER CENT, eye drops
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 drug may cause undesirable effects, but they do not occur systematically in everyone.
Undesirable effects of undetermined frequency (cannot be estimated on the basis of available data):
- Allergic reaction to product components
- Eye irritation which may include burning and stinging of the eyes, transiently after instillation.
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 Centres Régionaux de Pharmacovigilance - Website: www.signalement-sante.gouv.fr
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW DO I USE OPTICRON 2 PER CENT, eye drops?
Keep out of sight and reach of children.
Do not use after the expiration date indicated on the packaging.
The opened bottle will keep for 15 days.
Store at temperatures below 25°C.
Protect from light.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What OPTICRON 2 PER CENT, eye drops contains
- The active substance is :
Sodium chromoglycate.................................................................................................. 2.00 g
per 100 ml
- The other components are : Sodium ededate, benzalkonium chloride, distilled water.
What OPTICRON 2 PER CENT, eye drops is and what it contains
This medicine is available as an eye drop.
3 ml, 4 ml or 5 ml bottle.
Marketing authorization holder
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Marketing authorization holder
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Manufacturer
AVENTIS PHARMA LE TRAIT
BOULEVARD INDUSTRIEL
ZONE INDUSTRIELLE
76580 LE TRAIT
Or
EXCELVISION
RUE DE LA LOMBARDIERE
07100 ANNONAY
Drug 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.