Bausch + Lomb Lacrinorm 0.2% ophthalmic gel

Lacrinorm 0.2% ophthalmic gel is a medication intended for the symptomatic treatment of dry eye, characterized by a lack of tears.

The active ingredient in this tear substitute is Carbomer (carbopol 980) at a dose of 0.2 g per 100 g of gel.
Its other ingredients are benzalkonium chloride, sodium hydroxide, sorbitol, and water for injection.

Dosage of Lacrinorm 0.2%

The usual recommended dosage is 1 drop of Lacrinorm 3 to 4 times daily, or more if necessary.
It is administered as easily as eye drops and is instilled directly into the eye.
Instillations of Lacrinorm 0.2% should be spaced throughout the day as needed.

If dry eye symptoms persist or worsen, consult a doctor to adjust treatment.

Contraindications for Lacrinorm 0.2% Gel

This ophthalmic gel should not be used in cases of allergy/hypersensitivity to its active ingredient or any of its components.
It is recommended to avoid wearing contact lenses during treatment due to the presence of benzalkonium in the formula.

If used simultaneously with another eye drop, instillations should be spaced 15 minutes apart.
It is recommended to inform your doctor or pharmacist if you have recently or currently been taking any other medication.

Brief visual disturbances may occur following the instillation of Lacrinorm gel, until the product is evenly distributed over the surface of the eye. It is therefore recommended not to drive machinery or vehicles immediately after application.

If you are pregnant and/or breastfeeding, consult your doctor or pharmacist before taking any medication.

To avoid contaminating Lacrinorm 0.2%, avoid touching the eye with the tip of the tube. The tube must also be securely closed after use.

Capacity: 10 g

For dry eyes and dry eyelids, we recommend Sensioptic hyaluronic acid-based doses.


LEAFLET
ANSM - Updated on: 04/09/2023
Name of the medicinal product
LACRINORM 0.2%, ophthalmic gel
Carbomer (carbopol 980)
Box
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
You must always use this medicine exactly as provided in this leaflet or by your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
Ask your pharmacist for advice or information.
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
You must talk to your doctor if you do not feel better or if you feel worse.
Keep this medicine out of the reach of children.
What is in this leaflet? 1. What is LACRINORM 0.2% eye gel and what is it used for?
2. What you need to know before using LACRINORM 0.2% eye gel?
3. How to use LACRINORM 0.2% eye gel?
4. Possible side effects?
5. How to store LACRINORM 0.2% eye gel?
6. Contents of the pack and other information.
1. WHAT IS LACRINORM 0.2% eye gel AND WHAT IS IT USED FOR?
Pharmacotherapeutic group: TEAR SUBSTITUTE - ATC code: S01XA20
(S: sense organ)
This eye gel is indicated for the symptomatic treatment of dry eye. You should contact your doctor if you do not feel any improvement or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE USING LACRINORM 0.2% Ophthalmic Gel?
Never use LACRINORM 0.2% Ophthalmic Gel:
· if you are allergic to carbomer or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using LACRINORM 0.2% Ophthalmic Gel.
Special warnings
Do not inject or swallow.
If you are taking another eye drop at the same time, wait 15 minutes between instillations.
Do not touch the tip of the tube to your eye.
Replace the cap after use. Precautions for use
If symptoms persist, CONSULT A DOCTOR so that your treatment can be adjusted.
Avoid wearing soft contact lenses during treatment due to the risk associated with the presence of benzalkonium chloride.
Children and adolescents up to 18 years of age
The safety and efficacy of LACRINORM 0.2% eye gel in children and adolescents, at the recommended adult dosage, has been established through clinical experience, but no clinical trial data are available.
Other medicines and LACRINORM 0.2% eye gel
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
LACRINORM 0.2% eye gel with food and drink
Not applicable.
Pregnancy, breastfeeding, and fertility
Based on available data, use in pregnant or breastfeeding women is possible. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist before taking this medicine.
Driving and using machines
Brief visual disturbances may occur after application of the product until the gel is evenly distributed over the surface of the eye.
LACRINORM 0.2% eye gel contains benzalkonium chloride.
This medicine contains 0.1 mg of benzalkonium chloride per gram of eye gel.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Remove contact lenses before application and wait at least 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye syndrome or disorders of the cornea (the clear layer at the front of the eye). If you experience any unusual sensations, stinging, or pain in your eyes after using this medicine, contact your doctor.
3. HOW TO USE LACRINORM 0.2% Ophthalmic Gel
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
Dosage
On average, 1 drop, 3 to 4 times a day, or more if the severity of symptoms requires it.
Method and route of administration
Ophthalmic use
Wash your hands thoroughly before applying the product.
Instill the drop of ophthalmic gel into the inner corner of the eye, looking upwards and gently pulling the lower eyelid downward.
Do not touch the eye with the tip of the tube.
Recap the tube after use.
Frequency of administration
Spread the instillations throughout the day as needed. Duration of treatment
If symptoms persist or worsen, consult an ophthalmologist to adjust your treatment.
Use in children and adolescents up to 18 years of age
The safety and efficacy of LACRINORM 0.2% eye gel in children and adolescents, at the recommended adult dosage, has been established by clinical experience, but no clinical trial data are available.
If you use more LACRINORM 0.2% eye gel than you should
Consult your doctor or pharmacist immediately.
In case of overdose, rinse with sterile saline.
If you forget to use LACRINORM 0.2% eye gel
Do not take a double dose to make up for a forgotten dose.
If you stop using LACRINORM 0.2% eye gel
Not applicable. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible:
· Blurred vision;
· A temporary burning sensation after instillation until the gel is evenly distributed over the surface of the eye;
· A feeling of sticky eyelids;
· Irritation or hypersensitivity reactions;
· Due to the presence of benzalkonium chloride, there may be a risk of eczema, irritation, and difficulty breathing.
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: https://signalement.social-sante.gouv.fr/
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE LACRINORM 0.2%, eye gel?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date shown on the outer packaging after EXP. The expiry date refers to the last day of that month.
Once opened, the tube should not be stored for more than 30 days.
This medicine should not be stored above 25°C.
Do not use this medicine if you notice any visible signs of deterioration. Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What LACRINORM 0.2% Eye Gel contains
· The active ingredient is:
Carbomer (carbopol 980).............................................................................................. 0.200 g
Per 100 g of eye gel
· The other ingredients are:
Sorbitol, benzalkonium chloride (see section 2.), sodium hydroxide, water for injection.
What LACRINORM 0.2% Eye Gel looks like and contents of the outer packaging
This medicine is presented as an eye gel.
5 g or 10 g tube.
Not all pack sizes may be marketed. Marketing Authorization Holder
LABORATOIRE CHAUVIN
416, RUE SAMUEL MORSE - CS99535
34961 MONTPELLIER
Marketing Authorization Holder
LABORATOIRE CHAUVIN
416, RUE SAMUEL MORSE - CS99535
34961 MONTPELLIER
Manufacturer
LABORATOIRE CHAUVIN
ZONE INDUSTRIELLE DE RIPOTIER 50 AVENUE JEAN MONNET
07200 AUBENAS
OR
DR GERHARD MANN CHEM. PHARM. FABRIK GMBH
BRUNSBÜTTELER DAMM, 165/173
13581 BERLIN - GERMANY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable. This leaflet was last revised:
[To be completed later by the holder]
{month YYYY}.
Other
Detailed information on this medicine is available on the ANSM (France) website.