NOTICE
ANSM - Updated on : 08/07/2022
Product name
CELLUVISC 4 mg/0.4 ml, eye drops in single-dose container
Sodium carmellose
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.
What does this leaflet contain?
1. What is CELLUVISC 4 mg/0.4 ml, eye drops in single-dose containers and what is it used for?
2. What do I need to know before using CELLUVISC 4 mg/0.4 ml, eye drops in single-dose containers?
3. How do I use CELLUVISC 4 mg/0.4 ml, eye drops in single-dose containers?
4. What are the possible side effects?
5. How should CELLUVISC 4 mg/0.4 ml be stored?
6. Package contents and other information.
1. WHAT IS CELLUVISC 4 mg/0.4 ml, eye drops in single-dose containers AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code: S01XA20
This medicine is used to relieve signs of irritation associated with dry eyes (when there are insufficient tears).
You should consult your doctor if you do not feel any improvement or if you feel less well.
2. WHAT DO I HAVE TO KNOW BEFORE USING CELLUVISC 4 mg/0.4 ml, eye drops in single-dose containers?
Never use CELLUVISC 4 mg/0.4 ml, eye drops in single-dose containers:
- if you are allergic to sodium carmellose or to any of the other ingredients of this medicine, as listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before using CELLUVISC.
If symptoms persist, CONSULT AN OPHTALMOLOGIST to adjust your treatment.
This eye drop is presented in single-use single-dose containers and contains no preservatives. There is therefore a risk of rapid bacterial contamination.
To avoid contamination or possible damage to the eye, do not touch the eye or any other surface with the tip of the lunidose.
Lunidose should be discarded immediately after use and not stored for future use.
Brief visual blurring may occur on instillation of the product until it spreads evenly over the surface of the eye.
Other drugs and CELLUVISC 4 mg/0.4ml, eye drops in single-dose containers
In the event of concomitant treatment with another eye drop, wait 15 minutes between instillations and finish with the most viscous product. CELLUVISC may delay the penetration of other drugs, so it should be instilled last if it is the most viscous.
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medication.
CELLUVISC 4 mg/0.4ml, eye drops in single-dose containers 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 taking this medicine.
Driving vehicles and operating machinery
Depending on the viscosity of the product, vision may be blurred for a few minutes after use. In this case, patients should be advised not to drive or operate machinery until normal vision has been restored.
CELLUVISC 4 mg/0.4ml, eye drops in single-dose containers contains sodium chloride, sodium lactate, potassium chloride, calcium chloride and purified water.
Not applicable.
3. HOW TO USE CELLUVISC 4 mg/0.4 ml, eye drops in single-dose containers?
Always use this medicine exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
The recommended dose is 1 drop in the eye(s) to be treated 2 to 4 times a day, and up to 8 times a day if dry eyes persist.
Method of administration
Local use.
OCULAR INSTILLATION.
One single dose treats both eyes.
Use a new single dose for each application during the day.
To ensure proper use of eye drops, certain precautions must be taken:
- Wash hands thoroughly before use,
- Do not touch the eye or any other surface with the dropper tip,
- Do not use a single-dose eye drop if the cap appears broken before use.
To use a single-dose unit, proceed as follows:
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1. Detach a single-dose unit from the blister pack.
2. Hold the unit-dose vertically (cap upwards). To open the unit-dose, turn the flat part completely to break the seal.
3. Gently pull the lower eyelid downwards, looking upwards. Turn the container upside down and press lightly to drop 1 drop into the eye(s) to be treated. Blink several times.
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When used, discard immediately. Do not store or reuse.
Frequency of administration
Distribute instillations throughout the day, as needed.
Duration of treatment
If symptoms persist or worsen, consult an ophthalmologist to adjust your treatment.
If you have used more CELLUVISC 4 mg/0.4 ml, eye drops in single-dose containers than you should have
Consult your doctor or pharmacist.
If you forget to use CELLUVISC 4 mg/0.4 ml, eye drops in single-dose containers
Do not take a double dose to make up for the one you forgot to take.
If you stop using CELLUVISC 4 mg/0.4 ml, eye drops in single-dose containers
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.
Common side effects
These side effects may occur in 1 to 9 patients out of 100.
Effects on the eye
- Eye irritation (including burning and discomfort).
Post-marketing data :
The following adverse reactions have been reported since the product was marketed:
Adverse reactions of undetermined frequency
- Allergic reactions (including swelling of the eye or eyelids).
- Eye discharge.
- Eye pain.
- Eyelid crusting or product residue.
- Visual disturbances.
- Superficial injury to the eye due to contact between the tip of the lunidose and the eye during administration, and/or superficial trauma to the cornea.
- Blurred vision.
- Tingling sensation.
- Sensation of something in the eye.
- Itchy eyes.
- Red eye.
- Increased tearing.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effect 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 CONSERVE CELLUVISC 4 mg/0.4 ml, eye drops in single-dose containers?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the single-dose container, aluminium sachet and packaging after EXP. The expiration date refers to the last day of that month.
Store at temperatures not exceeding 25°C.
Keep single-dose containers in the sachet and the sachet in the box, away from light and moisture.
After opening: use immediately and discard single-dose container after use. Do not keep the single-dose container after opening.
Do not use this medicine if you notice any damage to the packaging, or if the solution has changed color or become cloudy.
Do not dispose of any medicine in the sewage or 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 CELLUVISC 4 mg/0.4 ml eye drops in single-dose containers contains
- The active substance is :
Carmellose sodium ..................................................................................................... 4.00 mg
- Other ingredients are:sodium chloride, sodium lactate, potassium chloride, calcium chloride, purified water.
What CELLUVISC 4 mg/0.4 ml, eye drops in single-dose containers is and what it contains
Eye drops.
Box containing 5 single-dose containers.
Box containing 10, 20, 30 or 90 single-dose containers in aluminium sachet. Each foil sachet contains 10 single-dose containers.
Not all presentations may be marketed.
Marketing authorization holder
ABBVIE
10 RUE DARCUEIL
94528 RUNGIS CEDEX
Marketing authorization holder
ABBVIE
10 RUE DARCUEIL
94528 RUNGIS CEDEX
Manufacturer
ALLERGAN PHARMACEUTICALS IRELAND
CASTLEBAR ROAD
WESTPORT
CO. MAYO
IRELAND
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
{month YYYY}.
Other
Not applicable.
Detailed information on this drug is available on the ANSM (France) website.