Liposic ophthalmic gel is intended for the symptomatic treatment of the serious effects of dry eye.
Its active substance is carbomer 980, dosed at 200 mg per 100 g of ophthalmic gel.
The other ingredients of its formula are sorbitol, cetrimide, medium-chain triglycerides, sodium hydroxide and purified water.
Dosage of Ophthalmic Gel Liposic
In adults, the usual recommended dose is 1 drop, to be instilled into the diseased eye/eyes 3 to 5 times a day depending on the severity of the symptoms.
The instillations should be distributed during the day, depending on the needs.
Talk to 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 that an ophthalmologist be consulted to adapt the treatment.
Contraindications of Liposic ointment
Liposic ophthalmic gel should not be used in the event of a history of allergy to any of its components, particularly cetrimide.
When wearing contact lenses, it is recommended that they be removed before applying the gel and then waiting 30 minutes after instillation before returning.
Flexible contact lenses should avoid being worn during treatment, due to the presence of cetrimide as a preservative.
If you are using concomitant treatment with another eye drop, it is best to wait at least 15 minutes between each application. Liposic should be the last medicine to be applied.
This ophthalmic gel is sterile until its first opening. It is therefore important to close it well, and to keep the tube clean during its use.
Liposic is not recommended for use during pregnancy or breast-feeding.
It is important to tell the doctor or pharmacist if you are taking or have recently taken any other medicines, especially if it is an eye drop, in order to avoid possible drug interactions.
After application of the Liposic ophthalmic gel, vision may be slightly blurred. It is therefore recommended to wait a few minutes, while the latter becomes clear again, before driving a machine or a vehicle.
Capacity: 10 g tube
ANSM - Updated on: 01/12/2024
LIPOSIC 2 mg/g, ophthalmic gel
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Carbomer................................................................................................................................. 2 mg
For 1 g of ophthalmic gel.
Each gram of ophthalmic gel contains 2 mg of carbomer.
For the full list of excipients, see section 6.1.
Ophthalmic gel: white, opalescent, high viscosity gel.
Symptomatic treatment of dry eye.
4.2. Dosage and method of administration
Treatment of dry eye requires that the dosage be individually adjusted.
Depending on the severity and intensity of symptoms, instill one drop into the conjunctival sac 3 to 5 times a day, approximately 30 minutes before bedtime (to avoid the risk of sticky eyelids).
Pediatric population
The safety and efficacy of LIPOSIC 2 mg/g ophthalmic gel in children and adolescents (up to 18 years), at the recommended adult dosage, has been established by clinical experience, but there are no clinical trial data available.
Mode of administration
OPHTHALMIC ROUTE.
Generally, an ophthalmologist should be consulted to treat keratoconjunctivitis sicca, which normally requires long-term or permanent treatment.
A drop of appropriate size is obtained by holding the tube upright above the eye during instillation.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Contact lenses should be removed prior to administration and replaced 30 minutes after LIPOSIC 2 mg/g ophthalmic gel has been instilled.
LIPOSIC 2 mg/g ophthalmic gel may prolong the contact time of topical ophthalmic medicinal products. If concomitant ocular treatment is being administered, it should be administered 15 minutes before instillation of LIPOSIC 2 mg/g ophthalmic gel (see section 4.5).
If dry eye symptoms continue or worsen, treatment should be stopped and an ophthalmologist should be consulted.
4.5. Interactions with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6. Fertility, pregnancy and breastfeeding
No studies have been carried out.
Pregnancy
There are no data on the use of carbomer in pregnant women.
Animal studies do not indicate a direct link with reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of LIPOSIC 2 mg/g ophthalmic gel during pregnancy.
No information is available on the excretion of carbomer and its metabolites in human milk. A risk to the newborn or infant cannot be excluded. A decision whether to discontinue breastfeeding or to discontinue/avoid treatment with LIPOSIC 2 mg/g ophthalmic gel should be made taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Fertility
No studies have been carried out.
4.7. Effects on ability to drive and use machines
LIPOSIC 2 mg/g, ophthalmic gel has moderate influence on the ability to drive and use machines.
Even when used as directed, this medication may decrease visual acuity for approximately 5 minutes due to filament formation after application of the gel. Therefore, patients should exercise caution when driving or operating machinery.
Adverse reactions are categorized by frequency using the following convention: very common (≥ 1/10), common (between ≥ 1/100 and < 1/10), uncommon (between ≥ 1/1,000 and < 1/100), rare (between ≥ 1/10,000 and < 1/1,000), very rare (< 1/10,000) or not known (frequency cannot be estimated from the available data).
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Eye conditions |
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very rare (< 1/10,000) |
burning sensation in the eye |
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redness of the eyes |
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eyelid eczema |
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foreign body sensation in the eye |
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giant papillary conjunctivitis |
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pruritus |
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feeling of stuck eyes |
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superficial punctate keratitis |
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watery eyes |
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blurred vision |
These reactions can occur due to the preservative present (cetrimide) or as a reaction to intolerance to one of the other components.
Blurred vision may occur after instillation of LIPOSIC 2 mg/g ophthalmic gel due to the high viscosity of the product. During clinical trials with LIPOSIC 2 mg/g ophthalmic gel, only one non-serious topical adverse reaction (eye burning sensation) was observed.
Pediatric population
No specific information was reported.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after drug authorization is important. It allows for continued monitoring of the drug's benefit/risk balance. Healthcare professionals report any suspected adverse reactions 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/ .
No cases of overdose have been reported.
Pediatric population
No special information has been reported regarding the pediatric population.
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: artificial tears, ATC code: S01XA20 .
LIPOSIC 2 mg/g ophthalmic gel is made from a high molecular weight hydrophilic polymer. Its pH and osmolality are similar to those of normal tear film. Due to its physical properties, the ophthalmic gel captures water and forms a transparent, lubricating and wetting film on the surface of the eye.
The structure of the gel is destroyed by the salts contained in tears and thus hydrates and lubricates. A study conducted on 54 patients with keratoconjunctivitis sicca showed that treatment with LIPOSIC 2 mg/g ophthalmic gel prolonged the tear film break-up time on average from 5.3 seconds to 11.2 seconds after 6 weeks. Schirmer test values increased on average from 4.8 mm to 10.7 mm after 6 weeks.
5.2. Pharmacokinetic properties
There are no controlled pharmacokinetic studies in animals or humans with this product. However, absorption or accumulation in ocular tissues can likely be excluded due to the high molecular weight of carbomer. Studies with an essentially similar product have shown that the ocular persistence time is estimated to be approximately 90 minutes.
Pediatric population
No data available.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
Cetrimide (preservative), sorbitol, medium chain triglycerides, sodium hydroxide (for pH adjustment), water for injection.
After opening the tube: 28 days.
6.4. Special storage precautions
Store at a temperature not exceeding 25°C.
6.5. Nature and contents of outer packaging
5 or 10 g of ophthalmic gel in tube (PE); box of 1 or 3.
Not all presentations may be marketed.
6.6. Special precautions for disposal and handling
No special requirements.
7. MARKETING AUTHORISATION HOLDER
416, RUE SAMUEL MORSE – CS99535
34961 MONTPELLIER
8. MARKETING AUTHORISATION NUMBER(S)
· 34009 359 308 7 3: 5 g in tube (PE); box of 1.
· 34009 359 309 3 4: 5 g in tube (PE); box of 3.
· 34009 359 310 1 6: 10 g in tube (PE); box of 1.
· 34009 359 311 8 4: 10 g in tube (PE); box of 3.
9. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION
[to be completed later by the holder]
[to be completed later by the holder]
Not applicable.
12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS
Drug not subject to medical prescription.
ANSM - Updated on: 01/12/2024
LIPOSIC 2 mg/g, ophthalmic gel
Carbomer
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.
What does this leaflet contain?
1. What is LIPOSIC 2 mg/g, ophthalmic gel and what is it used for?
2. What you need to know before using LIPOSIC 2 mg/g, ophthalmic gel?
3. How to use LIPOSIC 2 mg/g, ophthalmic gel?
4. What are the possible side effects?
5. How to store LIPOSIC 2 mg/g, ophthalmic gel?
6. Package contents and other information.
1. WHAT IS LIPOSIC 2 mg/g, ophthalmic 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 that contains 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 do not produce enough tears, they can become dry, red, and sore. LIPOSIC 2 mg/g eye gel will help keep your eyes comfortable.
LIPOSIC 2 mg/g, ophthalmic gel is a highly viscous gel that forms a protective layer on the eye and keeps the ocular surface hydrated.
It is easy and comfortable to use and is particularly suitable for the symptomatic treatment of the serious effects 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 LIPOSIC 2 mg/g, ophthalmic gel?
Never use LIPOSIC 2 mg/g, 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 LIPOSIC 2 mg/g, ophthalmic gel .
Children and adolescents
The safety and efficacy of LIPOSIC 2 mg/g ophthalmic gel in children and adolescents (up to 18 years), at the recommended adult dosage, has been established by clinical experience, but there are no clinical trial data available.
Other medicines and LIPOSIC 2 mg/g, ophthalmic 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, ophthalmic gel with food and drink
Not applicable.
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.
Ask your doctor or pharmacist for advice before taking any medication. You may be able to use this medication, but you may also be advised to take an alternative.
Contact lenses
To prevent filaments or clumps from forming on contact lenses, they must be removed before applying LIPOSIC 2 mg/g ophthalmic gel. They can be reinserted 30 minutes later.
Driving and operating machinery
All ophthalmic preparations may 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 your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.
The recommended dose is to instill 1 drop of gel in the corner of the eye, near the nose, 3 to 5 times a day and approximately 30 minutes before bedtime.
Follow these instructions carefully:
1. Wash your hands thoroughly.
2. Turn the cap.
3. Look up and gently pull down your lower eyelid.
4. Hold LIPOSIC 2 mg/g eye gel just above your eye and gently squeeze until a little gel falls into the space between the eyeball and lower eyelid.
5. Release the lower eyelid and, keeping the eye open, move it so that the gel is distributed evenly 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), at the recommended adult dosage, has been established by clinical experience, but there are no clinical trial data available.
If you use more LIPOSIC 2 mg/g eye gel than you should
If you have instilled 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, ophthalmic gel
Do not take a double dose to make up for a forgotten dose.
If you stop using LIPOSIC 2 mg/g, ophthalmic gel
Dry eye syndrome can worsen if not treated properly or adequately.
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.
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, burning, itching, and irritation of the eye.
If you notice any side effects not listed in this leaflet, or if any of the side effects get serious, please tell your doctor or pharmacist.
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 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 carton 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 opening, so it is important to keep the tube as clean as possible during use.
The cap is flat to allow the tube to be held upright.
Discard any remaining product within 28 days of first opening the tube. It may be helpful to write the date the tube was opened 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 PACKAGE AND OTHER INFORMATION
What LIPOSIC 2 mg/g, ophthalmic gel contains
· The active substance is:
Carbomer........................................................................................................................ 2 mg
For 1 g of ophthalmic gel
Each gram of ophthalmic gel contains 2 mg of carbomer.
· The other components are:
Cetrimide, sorbitol, medium chain triglycerides, sodium hydroxide (for pH adjustment), water for injection.
· The preservative of LIPOSIC 2 mg/g, ophthalmic gel is cetrimide.
What LIPOSIC 2 mg/g, ophthalmic gel looks like and contents of the outer packaging
This medicine comes in the form of a high viscosity white ophthalmic gel.
Tube of 5 or 10 g of ophthalmic gel; boxes of 1 or 3 tubes.
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
This medicine is authorized in the member states of the European Economic Area under the following names: In accordance with current regulations.
The last date this notice was revised is:
[to be completed later by the holder]
{month YYYY}.
Detailed information on this medicine is available on the ANSM (France) website.
Health Education Council:
LIPOSIC 2 mg/g ophthalmic gel is used for the symptomatic treatment of dry eye, which is dehydration of the eye surface caused by disorders of tear secretion or tear quality. Dry eye can also occur when the eyelids cannot be closed, partially or completely.
This condition is very common, with one in five patients who consult an ophthalmologist suffering from dry eye. The causes are numerous: 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” ?
During 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 symptoms appear in the patient (burning sensation, dry eyes, grittiness in the eyes, pressure, sensitivity to light).
LIPOSIC 2 mg/g, ophthalmic gel is a soothing gel that moistens the eye and helps lubricate 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 for longer.
Your ophthalmologist has prescribed a tear substitute to ease your eye discomfort. In addition to consistently using the preparation as directed, you should follow these guidelines:
· Air out your apartment or house several times a day.
· Make sure you drink enough.
· Go out for fresh air frequently.
· Do not point fans towards your eyes.
· Take breaks when working in front of a computer screen.
However, it is important that you see your eye doctor regularly for follow-up exams, as dry eye can lead to serious illness if not treated properly.
