Leaflet: information for the user

Lipolasic 2 mg/g eye gel

Carbomer

Read this leaflet carefully before you start using this medicinebecause it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• Ifyou experience any side effects, consult your doctor or pharmacist,evenif they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve.

1. What Lipolasic is and for what it is used

2. What you need to know beforestarting touse Lipolasic

3. How to use Lipolasic

4. Possible side effects

5. Storage of Lipolasic

6. Contents of the pack andadditional information

Lipolasic is a highly viscous, white gel that contains a lubricant used as a substitute for natural tears. Normally, your eyes produce enough natural tears to move easily and comfortably. If your eyes do not produce enough tears, they may become dry, red, and painful. Lipolasic will help keep your eyes free of discomfort.

Lipolasic is a highly viscous gel that forms a protective layer over the eye and keeps its surface moist.

It is easy and comfortable to use, and is especially suitable for symptomatic treatment of severe dry eye.

You should consult a doctor if it worsens or does not improve.

Do not use Lipolasic

-if you are allergic to carboxymethyl cellulose or any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Lipolasic.

Children and adolescents up to 18 years

In clinical practice, the safety and efficacy of Lipolasic have been established in children and adolescents at the recommended adult dose, but there are no data from clinical trials.

Use of other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

When Lipolasic is used at the same time as other eye drops or ointments, leave an application time interval of approximately 15 minutes between the use of these other medications and Lipolasic, which should always be the last medication applied.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

You may be recommended this medication, but you may also be able to use an alternative.

Driving and operating machinery

Like all eye preparations, you may have blurred vision for a short period of time after applying the gel. Wait until your vision is clear before driving or operating machinery.

Contact lenses

To avoid streaks or gel blobs on contact lenses, remove them before applying Lipolasic. You can reinsert them 30 minutes later.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is to apply one drop to the corner of the eye closest to the nose, 3-5 times a day, and approximately 30 minutes before going to bed.

Follow these instructions carefully:

1. Wash your hands thoroughly.

2. Remove the cap.

3. Look up and gently pull the lower eyelid downwards.

4. Hold the Lipolasic tube just above your eye and press gently until the gel falls into the space between the eyeball and the lower eyelid.

5. Release the lower eyelid, and move your eye while it is open to ensure that the gel covers the entire eye.

6. Repeat the process in the other eye, if necessary.

Children and adolescents up to 18 years old

In clinical practice, the safety and efficacy of Lipolasic in children and adolescents at the recommended adult dose have been established, but there are no data from clinical trials.

If you use more Lipolasic than you should

If you have applied too much Lipolasic, rinse the gel from your eyes.

If you forget to use Lipolasic

Do not apply a double dose to compensate for the missed dose.

If you interrupt treatment with Lipolasic

The dry eye disorder may worsen if treated incorrectly or inadequately. If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Likeall medications,this medicationmay cause adverse effects, although not all people experience them. Your eyes may hurt a little when you apply the gel and your vision may become blurry. These effects will disappear in a few minutes.

Some reports of allergies (hypersensitivity) have been received after administration of Lipolasic, due to one of the excipients in the composition (it may affect 1 in 10,000 people).

Other adverse effects that have rarely been reported (it may affect 1 in 10,000 people) are sticky eyelids, conjunctivitis (red eyes), speckling (or dots) on the cornea (the surface of the eye), swollen eyes, burning, itching, and eye irritation.

If any of the adverse effects you experience are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25ºC (room temperature)

Lipolasic is sterile until the tube is opened for the first time. It is essential to keep the tube as clean as possible during use.

The tube has a flat cap, allowing it to be in a vertical position.

Dispose of the remaining contents 28 days after opening the tube. It may be helpful to write on the tube the date it was first opened.

Remember that this medication is for you. Do not give it to another person.

Medications should not be disposed of through drains or trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Lipolytic Composition

The active ingredient iscarbomer. Each tube contains 2.0 mg of carbomer per g of gel.

The other components arecetrimide, sorbitol, medium-chain triglycerides, sodium hydroxide (for pH adjustment) and water for injection.

Lipolytic eye gel contains the preservative cetrimide.

Product Appearance and Packaging Content

Lipolytic eye gel is a white, highly viscous gel.

Packaging sizes:

Tubes of 5g of gel. Boxes containing 1 or 3 tubes of 5g of eye gel.

Tubes of 10g of gel. Boxes containing 1 or 3 tubes of 10g of eye gel.

Only some packaging sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Bausch & Lomb S.A.

Avda. Valdelaparra, 4

28108 – Alcobendas, Madrid

Spain

Responsible Manufacturer

Dr. Gerhard Mann

Chem.-pharm. Fabrik GmbH

Brunsbuetteler Damm 165-173

13581 Berlin (Germany)

Laboratoire Chauvin

Zone Industrielle de Ripotier

50 Avenue Jean Monnet

07200 Aubenas (France)

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

United KingdomLiposic

BelgiumLiposic

GreeceLiposic

SpainLipolasic

FranceLiposic

IrelandLiposic

ItalyLipovisc

PortugalLiposic

Last review date of this leaflet:June 2018

For detailed and updated information on this medicinal product, please consult the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

Other information

Lipolasic is used for the symptomatic treatment of "dry eye", a dehydration of the eye surface resulting from alterations in tear secretion or quality, or when the eyelids cannot be closed partially or completely.

This eye disease is so common that one in five patients who visit an ophthalmologist suffer from it. Many factors can cause it, such as reduced tear production in old age, air conditioning, working on computers, hormonal changes during menopause, etc. Environmental and climatic factors can also play a role in the development of dry eye.

What do we understand by "dry eye"?

During the day, we blink an average of 14,000 times. With each palpebral movement, a thin film of tears is distributed over the surface of the eyeball, keeping it smooth, clean, and moist, and protecting the eye from contaminants. When the volume or composition of the tear film is altered, desiccation (drying) of the cornea and conjunctiva occurs, and the patient experiences symptoms such as burning, feeling of dry eye, feeling of foreign body or pressure, and light sensitivity.

Lipolasic is a soothing gel that moistens the eyes and provides a lubrication to the eyes and eyelids similar to that of tears. The carbomer in Lipolasic gel increases the thickness of the gel, keeping it in contact with the eye for a longer period of time.

Your ophthalmologist has prescribed a tear substitute for the relief of your eye discomfort. In addition to using it consistently, you should follow these recommendations:

• Ventilate your apartment or house several times a day.
• Make sure to drink enough.
• Take breaks when working in front of a computer screen.
• Do not direct the ventilation outlets towards your eyes.
• Take breaks when working in front of a computer screen.

However, it is also important to consult your ophthalmologist regularly for follow-up, as dry eye can lead to a serious disease if it is not treated correctly or adequately.