Bausch + Lomb Liposic ophthalmic gel

Liposic Ophthalmic Gel is intended for the symptomatic treatment of the serious effects of dry eye.

Its active ingredient is carbomer 980, dosed at 200 mg per 100 g of ophthalmic gel.
The other ingredients in its formula are sorbitol, cetrimide, medium-chain triglycerides, sodium hydroxide, and purified water.

Dosage of Liposic Ophthalmic Gel

For adults, the usual recommended dosage is 1 drop, to be instilled into the affected eye(s) 3 to 5 times daily depending on the severity of symptoms.
Instillations should be spaced throughout the day, as needed.
Consult your doctor or pharmacist if you feel that the effect of the ophthalmic gel is too strong or too weak.
If symptoms persist, it is recommended to consult an ophthalmologist so that the latter can adjust the treatment.

Contraindications for Liposic Ointment

Liposic eye gel should not be used if you have a history of allergy to any of its ingredients, particularly cetrimide.
If you wear contact lenses, it is recommended to remove them before applying the gel, and then wait 30 minutes after application before reinserting them.
Soft contact lenses should not be worn during treatment due to the presence of cetrimide as a preservative.

If you are using another eye drop concomitantly, it is best to wait at least 15 minutes between each application. Liposic should be the last medication to be applied.
This eye gel is sterile until first opened. It is therefore important to keep it tightly closed and keep the tube clean during use.

The use of Liposic during pregnancy or breastfeeding is not recommended.

It is important to inform your doctor or pharmacist if you are taking or have recently taken any other medication, particularly eye drops, to avoid potential drug interactions.

After applying Liposic eye gel, your vision may be slightly blurred. It is therefore recommended to wait a few minutes for your vision to clear again before driving a vehicle or machinery.

Capacity: 10g tube

Hydrating your eyes and skin also involves taking dietary supplements containing essential fatty acids, such as Nutrilarm Théa capsules.


LEAFLET

ANSM - Updated on: 01/12/2024

Name of the medicinal product

LIPOSIC 2 mg/g, ophthalmic gel

Carbomer

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.

What is in this leaflet?

1. What is LIPOSIC 2 mg/g eye gel and what is it used for?

2. What you need to know before using LIPOSIC 2 mg/g eye gel?

3. How to use LIPOSIC 2 mg/g eye gel?

4. Possible side effects?

5. How to store LIPOSIC 2 mg/g eye gel?

6. Contents of the pack and other information.

1. WHAT IS LIPOSIC 2 mg/g eye gel AND WHAT IS IT USED FOR?

Pharmacotherapeutic group: Artificial tears - ATC code: S01XA20.

LIPOSIC 2 mg/g eye gel is a highly viscous, whitish gel containing a lubricant used as a substitute for natural tears. Your eyes normally produce just enough natural tears to allow them to move easily and comfortably. If your eyes don't produce enough tears, they can become dry, red, and sore. LIPOSIC 2 mg/g ophthalmic gel will help keep your eyes comfortable.

LIPOSIC 2 mg/g ophthalmic gel is a highly viscous gel that forms a protective layer over the eye and keeps the ocular surface moisturized.

It is easy and comfortable to use and is particularly suitable for the symptomatic treatment of the serious effects of dry eye.

You should consult your doctor if you do not experience improvement or if you feel worse.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE LIPOSIC 2 mg/g ophthalmic gel?

Do not use LIPOSIC 2 mg/g 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 LIPOSIC 2 mg/g eye gel.

Children and adolescents

The safety and efficacy of LIPOSIC 2 mg/g eye gel in children and adolescents (up to 18 years of age), at the recommended adult dosage, has been established through clinical experience, but no clinical trial data are available.

Other medicines and LIPOSIC 2 mg/g eye gel

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If you are using other eye drops or ointments at the same time, leave an interval of approximately 15 minutes between applications. Liposic 2 mg/g eye gel should be the last medication to be applied.

Liposic 2 mg/g eye gel with food and drink

Not applicable.

Pregnancy and breastfeeding

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.

Ask your doctor or pharmacist before taking any medicine. You may be able to use this medicine, but an alternative may be recommended.

Contact lenses

To prevent filaments or clumps from forming on contact lenses, they must be removed before applying Liposic 2 mg/g eye gel. They can be reinserted 30 minutes later.

Driving and using machines

All ophthalmic preparations can cause blurred vision immediately after instillation.

Wait until your vision is clear before driving or operating machinery.

3. HOW TO USE LIPOSIC 2 mg/g, 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.

The recommended dose is to instill 1 drop of gel into the corner of the eye, near the nose, 3 to 5 times a day, approximately 30 minutes before bedtime.

Follow these instructions carefully:

1. Wash your hands thoroughly.

2. Turn off the cap.

3. Look upwards and gently pull down your lower eyelid.

4. Hold LIPOSIC 2 mg/g ophthalmic gel just above your eye and gently squeeze until a little gel falls into the space between the eyeball and the lower eyelid.

5. Release the lower eyelid and, keeping the eye open, move it so that the gel is evenly distributed over the eye.

6. Repeat in the other eye if necessary.

Use in children and adolescents

The safety and efficacy of LIPOSIC 2 mg/g ophthalmic gel in children and adolescents (up to 18 years of age), at the recommended adult dosage, have been established through clinical experience, but no clinical trial data are available.

If you use more LIPOSIC 2 mg/g eye gel than you should

If you instill too much LIPOSIC 2 mg/g eye gel, the gel will be washed out of your eyes.

If you forget to use LIPOSIC 2 mg/g eye gel

Do not take a double dose to make up for a forgotten dose.

If you stop using LIPOSIC 2 mg/g eye gel

Dry eye syndrome can worsen if it is not treated correctly or adequately.

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.

You may experience a slight stinging in your eyes when the gel is applied, and your vision may become blurred. These effects disappear within a few minutes.

A few cases of allergy (hypersensitivity) have been reported after use of LIPOSIC 2 mg/g eye gel (may affect up to 1 in 10,000 people). This is due to one of the ingredients in the formulation.

Other side effects have been reported rarely (may affect up to 1 in 10,000 people). They include sticky eyelids, conjunctivitis (red eyes), spots (or dots) on the cornea (surface of the eye), swollen eyes, a burning sensation, itching, and irritation of the eye.

If you notice any side effects not listed in this leaflet, or if any of the side effects become serious, please tell your doctor or pharmacist.

Reporting 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: French 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 LIPOSIC 2 mg/g, ophthalmic gel?

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date printed on the packaging and tube after EXP. The expiry date refers to the last day of that month.

Store LIPOSIC 2 mg/g ophthalmic gel at a temperature not exceeding 25°C.

LIPOSIC 2 mg/g ophthalmic gel is sterile until first opened, so it is important to keep the tube as clean as possible during use.

The cap is flat to allow the tube to be kept upright.

Discard any remaining product within 28 days of first opening the tube. It may be helpful to note the date of opening on the tube.

Remember: this medicine is for you. Do not give it to anyone else.

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 LIPOSIC 2 mg/g eye gel contains

· The active ingredient is:

Carbomer........................................................................................................................ 2 mg

Per 1 g of eye gel

Each gram of eye gel contains 2 mg of carbomer.

· The other ingredients are:

Cetrimide, sorbitol, medium-chain triglycerides, sodium hydroxide (for pH adjustment), water for injection.

· The preservative in LIPOSIC 2 mg/g eye gel is cetrimide.

What LIPOSIC 2 mg/g eye gel looks like and contents of the outer packaging

This medicine is presented as a white, high-viscosity eye gel.

Tubes of 5 or 10 g of eye gel; boxes of 1 or 3 tubes.

Not all presentations 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

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 medicinal product in the Member States of the European Economic Area

This medicinal product is authorized in the Member States of the European Economic Area under the following names: In accordance with current regulations.

This leaflet was last revised:

[to be completed later by the holder]

{month YYYY}.

Others

Detailed information on this medicinal product is available on the ANSM website (France).

Health Education Council:

LIPOSIC 2 mg/g ophthalmic gel is used for the symptomatic treatment of dry eye, which is dehydration of the ocular surface caused by disorders of tear secretion or tear quality. Dry eye can also occur when the eyelids cannot be partially or completely closed.

This disorder is very common; one in five patients who consult an ophthalmologist suffers from dry eye. There are many causes: reduced tear production with age, air-conditioned rooms, computer work, hormonal changes during menopause, etc. Environmental and climatic effects can also play a role in the development of dry eye.

What do we mean by the term "dry eye"?

Over the course of a day, we blink an average of 14,000 times. With each blink, a very thin tear film covers the surface of the eyeball, keeping it smooth, clean, and moist, and protecting the eye from pollutants. When the volume or composition of the tear film is disrupted, desiccation (dryness) of the cornea and conjunctiva occurs, and the patient experiences symptoms (burning sensation, dry eyes, grittiness, pressure, sensitivity to light).

LIPOSIC 2 mg/g ophthalmic gel is a soothing gel that moistens the eye and lubricates the eyes and eyelids. The carbomer in LIPOSIC 2 mg/g ophthalmic gel increases its consistency, allowing the gel to remain in contact with the eye longer.

Your ophthalmologist has prescribed a tear substitute that will alleviate your eye discomfort. In addition to consistently using the preparation as directed, you should follow these guidelines:

· Ventilate your apartment or house several times a day.

· Make sure you drink enough water.

· Go outside and get fresh air frequently.

· Do not point fans at your eyes.

· Take breaks when working in front of a computer screen.

However, it is important that you see your ophthalmologist regularly for follow-up exams, as dry eye can lead to serious illness if not treated properly.