Package Insert: Information for the User

LACRYVISC 3mg/g Ophthalmic Gel

Carbomer

Read this entire package insert carefullybefore starting to use this medication,because it contains important information for you.

Follow exactly the medication administration instructions contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• For advice on any matter relating to this medicine or for information about any side effects, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section4.
• You must consult a doctorif your condition worsens or does not improve after 3 days.

Lacryvisc is a liquid eye gel, which contains the active ingredient called carbomer,whichis a highly viscous eye lubricant, capable of forming drops. After its local application on the eye, it forms a protective, highly adherent, and long-lasting lubricating film.

It is used for symptomatic relief of eye irritation and drynessin adults.

Consult a doctor if it worsens or does not improve after 3 days.

Do not use Lacryvisc

If you are allergic to carboxymethylcellulose or any of the other ingredientsof this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Lacryvisc.

Use this gel only in your eye(s).

The tip of the container should not come into contact with any surface, including the eye, as it may cause eye injury and the gel may become contaminated.

It is not recommended to wear contact lenses during treatment with this medication. See the section “Lacryvisc contains benzalkonium chloride”.

If you have iritis or corneal disease, you should consult your doctor who will determine whether or not it is possible to use Lacryvisc as treatment.

If eye pain, changes in vision, eye irritation, persistent redness, or if symptoms worsen or last more than 3 days, discontinue treatment and consult your doctor.

Children and adolescents up to 18 years of age

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

Use of Lacryvisc with other medications

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

Pregnancy, breastfeeding, and fertility

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

This medication may be used during pregnancy and breastfeeding.

Driving and operating machinery

You may notice that your vision becomes blurry for a short time after applying the medication. If this occurs, wait until the symptom disappears and your vision is clear before driving vehicles or operating machinery.

Lacryvisc contains benzalkonium chloride

This medication contains 0.001 mg of benzalkonium chloride in each dose equivalent to 0.05 mg/g.

Benzalkonium chloride may be absorbed by soft contact lenses, altering their color. Remove contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (transparent layer at the front of the eye). Consult your doctor if you feel a strange sensation, burning, or pain in the eye after using this medication.

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

The recommended dose is one drop in the eye(s) 2 to 4 times a day, or each time you feel eye discomfort associated with dry eye.

In certain cases and according to your doctor's instructions, Lacryvisc may be applied more frequently.

Children and adolescents up to 18 years of age

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

Senior patients

Lacryvisc can be used in senior patients (over 65 years old), and no dose adjustment is necessary.

Usage instructions

To administer Lacryvisc correctly, follow the steps described below:

Since it is a sterile medication, the following instructions are recommended:

-Each patient will use their own container.

-The gel application must be performed with the utmost cleanliness, avoiding contact of the tube tip with any surface (including eyelid, fingers, etc.).

-After each application, close the container tightly.

-Lacryvisc should not be used after 4 weeks from the first opening of the tube and should be discarded even if not fully consumed.

If you need to apply any other medication to your eyes in addition to Lacryvisc, wait at least 5 minutes between the application of both medications. Lacryvisc should be administered last.

If you use more Lacryvisc than you should

Given its exclusive ophthalmic administration, the possibility of overdose is not anticipated.

In case of overdose or accidental ingestion, consult your doctor immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Lacryvisc

Do not use a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The following reactions may appear in your eyes:

Very frequent (may affect more than 1 in 10 people): Blurred vision.

Frequent (may affect up to 1 in 10 people): Eyestrain, crust on the eyelid, eye irritation.

Rare (may affect up to 1 in 100 people): Swelling of the eye, eye pain, eye itching, eye redness, increased tear production.

Or reactions in other parts of your body:

Rare (may affect up to 1 in 100 people): Skin inflammation.

Additional adverse effects have been observed during post-marketing experience with unknown frequency (cannot be estimated from available data): allergy (hypersensitivity).

Reporting of 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 the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 86°F (30°C).

Keep the container perfectly closed. The contents of the tube are sterile until its first opening.

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

To prevent infections, discard the tube 4 weeks after it has been opened for the first time.

Note the date of opening the tube in the reserved box in the box.

Medicines should not be thrown away through the drains or in the trash. Dispose of the containers and medicines that you do not need at thePharmaceuticalTakeBackSiteofthe pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines that you do not need. In this way, you will help protect the environment.

Composition of Lacryvisc

• The active ingredient is carbomer. Each gram of gel contains 3mg of carbomer.
• The other components are benzalkonium chloride, sorbitol (E-420), sodium hydroxide and purified water.

Appearance of the product and contents of the packaging

Lacryvisc is a liquid, slightly opaque and slightly yellowish eye gel.

The gel is presentedin a box containing a10g tube with a plastic dispensing tip and a plastic stopper.

Marketing Authorization Holder

Alcon Healthcare S.A.

World Trade Center Almeda Park

Plaça de la Pau s/n, Edificio 6, planta 3

08940 - Cornellà de Llobregat (Barcelona)

Spain

Responsible for Manufacturing

S.A. Alcon-Couvreur N.V.

Rijksweg 14, B-2870 Puurs,

Belgium

or

Alcon Laboratories Belgium

Lichterveld 3

2870 Puurs-Sint-Amands

Belgium

Last review date of this leaflet:February 2018

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/