NOTICE
ANSM - Updated on : 11/02/2022
Product name
LACRIFLUID 0.13 PER CENT, eye drops solution in single-dose container
Carbomer 980
Cover
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.
What does this leaflet contain?
1. What is LACRIFLUID 0.13 PER CENT, eye drops in solution for single-dose containers and what is it used for?
2. What do I need to know before using LACRIFLUID 0.13 PER CENT, eye drops for single-dose containers?
3. How do I use LACRIFLUID 0.13 PER CENT, eye drops for single-dose containers?
4. What are the possible side effects?
5. How should LACRIFLUID 0.13 PER CENT, eye drops for single-dose containers, be stored?
6. Package contents and other information.
1. WHAT IS LACRIFLUID 0.13 PER CENT, eye drops for single-dose containers AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code
LACRYMAL SUBSTITUTE, ATC code: S01XA20 (S = sensory organs)
LACRIFLUID 0.13 PER CENT, eye drops in solution in single-dose containers is indicated for dry eyes.
2. WHAT DO I HAVE TO KNOW BEFORE USING LACRIFLUID 0.13 PER CENT, eye drops in solution for single-dose containers?
Never use LACRIFLUID 0.13 PER CENT, eye drops for solution in single-dose containers.
- if you are allergic to any of the other ingredients listed in section 6.
Warnings and precautions
Do not inject or swallow.
Do not exceed the prescribed dose.
If symptoms persist or worsen, consult your doctor.
This eye drop solution in single-dose containers does not contain any preservatives. Do not store opened single-dose containers for future use.
Children and adolescents
Children and adolescents up to 18 years of age.
The safety and efficacy of LACRIFLUID 0.13 PER CENT, eye drops for solution in single-dose containers, at the dosage recommended for adults has been established by clinical experience, but no clinical study data are available.
Other drugs and LACRIFLUID 0.13 PER CENT, eye drops for solution in single-dose containers
If you are taking another eye drop, wait 15 minutes between instillations.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
LACRIFLUID 0.13 PER CENT, eye drop solution in single-dose container with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
Under normal conditions of use, this medicine may be used during pregnancy and breast-feeding.
Ask your doctor or pharmacist for advice before taking any medication.
Driving vehicles and operating machinery
Visual disturbance may occur after instillation of the product and may last a few minutes. Wait until normal vision is restored before driving or operating machinery.
LACRIFLUID 0.13 PER CENT, eye drops in solution in single-dose containers contains excipient(s):
Not applicable.
3. HOW TO USE LACRIFLUID 0.13 PER CENT, eye drops in single-dose containers?
Dosage
Place one drop of eye drops in the affected eye(s) and repeat 2 to 3 times a day as required.
Method of administration
Ophthalmic route
- Each single dose contains enough eye drops to treat both eyes.
- Wash hands thoroughly before use.
- Shake the dose vigorously, opening downwards, before adding a drop.
- Pull the lower eyelid downwards and look upwards. Apply gentle, gradual pressure on the lidose to instill a drop into the inner corner of the eye.
- Avoid contact of the tip with the eye and eyelids.
- Dispose of one dose after use. Do not keep it for future use.
If you feel that the effect of LACRIFLUID 0.13 PER CENT, eye drops in single-dose containers is too strong or too weak, consult your doctor or pharmacist.
If you have used more LACRIFLUID 0.13 PER CENT, eye drops in single-dose containers than you should have
Accidental overdoses by eye or mouth are not dangerous.
If you forget to use LACRIFLUID 0.13 PER CENT, eye drops in single-dose containers
Do not take a double dose to make up for the one you forgot to take.
If necessary, you can put a drop of eye drops into the affected eye(s) and then continue your treatment as originally planned.
If you stop using LACRIFLUID 0.13 PER CENT, eye drops in solution in single-dose containers
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this product may cause undesirable effects, but they do not occur systematically in everyone.
- visual disturbance, temporary burning or stinging sensation after instillation until the eye drops spread evenly over the surface of the eye;
- sensation of stuck eyelids. ;
- irritation or hypersensitivity reactions.
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 TO USE LACRIFLUID 0.13 PER CENT, eye drops in solution in single-dose containers?
Keep out of sight and reach of children.
Do not use after the expiration date indicated on the box.
Discard a single-dose container after use. Do not keep opened single-dose containers for future use.
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 LACRIFLUID 0.13 PER CENT, eye drops in solution in single-dose containers contains
- The active substance is :
Carbomer 980 ............................................................................................................... 0.13 g
For 100 g of solution.
- The other components are :
Excipients: sorbitol, edetate disodium, sodium hydroxide, water for injection.
What LACRIFLUID 0.13 PER CENT is and what it contains
This medicine comes in the form of an eye drop solution in a single-dose container containing 0.4 g of solution. Thesolution is colorless and translucent. Boxes of 10, 20, 30 or 60 single-dose containers. Single-dose containers are packaged in sachets of 5 single-dose containers.
Marketing authorization holder
LABORATOIRES EUROPHTA
"LES INDUSTRIES
2, RUE DU GABIAN
98000 MONACO
Marketing authorization holder
LABORATOIRES EUROPHTA
"LES INDUSTRIES
2, RUE DU GABIAN
98000 MONACO
Manufacturer
LABORATOIRE UNITHER
ESPACE INDUSTRIEL NORD
151, RUE ANDRE DUROUCHEZ
CS 28028
80084 AMIENS CEDEX 2
FRANCE
Or
EXCELVISION
RUE DE LA LOMBARDIERE
07100 ANNONAY
FRANCE
Or
LABORATOIRE UNITHER
1 RUE DE LARQUERIE
50200 COUTANCES
FRANCE
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]
< {MM/YYYY}>< {month/YYYY}.>
Other
Not applicable.
Detailed information on this drug is available on the ANSM (France) website.