Lacrinorm 0.2% ophthalmic gel is a medicine intended for the symptomatic treatment of dry eye, characterised by a lack of tears.
The active substance in this tear substitute is Carbomère (carbopol 980) containing 0.2 g per 100 g of gel.
Its other ingredients are benzalkonium chloride, sodium hydroxide, sorbitol and water for injection.
Lacrinorm's dose 0.2%
The dosage usually recommended is 1 drop of Lacrinorm 3 to 4 times a day, or more if necessary.
He also engulfs himself as simply as an eye drops, and ingested himself directly in the eye.
Lacrinorm instillations 0.2% should be distributed during the day as required.
If dry eye disorders persist or worsen, a doctor should be consulted to adjust treatment.
Contraindications of Lacrinorm 0.2% gel
This ophthalmic gel should not be used in an allergy/hypersensitivity to its active substance or to any of its components.
It is recommended to avoid wearing contact lenses due to the presence of benzalkonium in the formula for the duration of treatment.
In case of simultaneous treatment with another eye drop, the instillations should be spaced 15 minutes apart.
It is recommended to notify your doctor or pharmacist of any new or current medicine.
A brief visual disturbance may occur following instillation of the lacrinorm gel, until the product is evenly distributed on the surface of the eye. It is therefore recommended not to drive machinery or vehicles immediately after its application.
In case of pregnancy and/or breast-feeding, ask your doctor or pharmacist for advice before taking a medicine.
In order not to contaminate Lacrinorm 0.2%, it is necessary not to touch the eye with the tube tip. The latter must also be effectively reopened after use.
Capacity: 10 gm
ANSM - Updated on: 04/09/2023
Carbomer (carbopol 980)
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medicine exactly as directed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You may need to read it again.
· Contact your pharmacist for any 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 should contact your doctor if you do not feel any improvement or if you feel worse.
Keep this medicine out of reach of children.
What does this leaflet contain?
1. What is LACRINORM 0.2%, eye gel and what is it used for?
2. What information should you know before using LACRINORM 0.2%, eye gel?
3. How to use LACRINORM 0.2%, eye gel?
4. What are the possible side effects?
5. How to store LACRINORM 0.2%, eye gel?
6. Package contents and other information.
1. WHAT IS LACRINORM 0.2%, Ophthalmic Gel AND WHAT IS IT USED FOR?
Pharmacotherapeutic group: TEAR SUBSTITUTE - ATC code: S01XA20
(S: sense organ)
This ophthalmic 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%, eye 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%, eye gel .
Special warnings
Do not inject, do not swallow.
If you are taking another eye drop at the same time, wait 15 minutes between the two instillations.
Do not touch the eye with the tip of the tube.
Recap the tube 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 of benzalkonium chloride.
Children and adolescents up to 18 years old
The safety and efficacy of LACRINORM 0.2%, ophthalmic gel in children and adolescents, at the recommended adult dosage, has been established by clinical experience, but there are no clinical trial data 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 for advice before taking this medicine.
Driving and operating machinery
Brief visual disturbance may occur after instillation 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 can 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 problems with the cornea (the clear layer at the front of the eye). If you experience any abnormal sensation, stinging, or pain in your eyes after using this medicine, contact your doctor.
3. HOW TO USE LACRINORM 0.2%, eye gel?
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. 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 route
· Wash your hands thoroughly before applying,
· Instill the drop of eye gel into the inner corner of the eye while looking upwards and pulling the lower eyelid slightly downwards,
· 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 the problems persist or worsen, consult an ophthalmologist so that your treatment can be adjusted.
Use in children and adolescents up to 18 years of age
The safety and efficacy of LACRINORM 0.2%, ophthalmic gel in children and adolescents, at the recommended adult dosage, has been established by clinical experience, but there are no clinical trial data 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 physiological serum.
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. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possibility of:
· blurred vision;
· transient burning sensation after instillation until the gel is evenly distributed on the surface of the eye;
· sensation of stuck eyelids;
· irritation or hypersensitivity reactions;
· due to the presence of benzalkonium chloride, risk of eczema, irritation and respiratory discomfort.
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 which is stated 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 be stored at a temperature not exceeding 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 PACKAGE AND OTHER INFORMATION
What LACRINORM 0.2% eye gel contains
· The active substance is:
Carbomer (carbopol 980).................................................................................................... 0.200 g
For 100 g of eye gel
· The other components are:
Sorbitol, benzalkonium chloride (see section 2.), sodium hydroxide, water for injection.
What is LACRINORM 0.2%, eye gel and contents of the outer packaging?
This medication comes in the form of an eye gel.
5g or 10g tube.
Not all presentations may be marketed.
Marketing Authorisation Holder
416, RUE SAMUEL MORSE - CS99535
34961 MONTPELLIER
Marketing Authorization Operator
CHAUVIN LABORATORY
416, RUE SAMUEL MORSE - CS99535
34961 MONTPELLIER
RIPOTIER INDUSTRIAL ZONE 50 AVENUE JEAN MONNET
07200 AUBENAS
OR
DR GERHARD MANN CHEM. PHARM. FABRIK GMBH
BRUNSBÜTTELER DAMM, 165/173
13581 BERLIN - GERMANY
Names of the medicine in the member states of the European Economic Area
Not applicable.
The last date this notice was revised is:
[to be completed later by the holder]
{month YYYY}.
