TILAVIST 20 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

Tilavist 20 mg/ml eye drops solution

nedocromil sodium

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Tilavist and what is it used for
2. What you need to know before using Tilavist
3. How to use Tilavist
4. Possible side effects
5. Storage of Tilavist
6. Package contents and additional information

1. What is Tilavist and what is it used for

Tilavist is an eye drop that contains the active ingredient nedocromil sodium, which inhibits the degranulation of sensitized mast cells, preventing the release of histamine and other inflammatory mediators. This medication is indicated in adults and children over 6 years of age for the symptomatic treatment of ocular conditions of an allergic nature, such as seasonal allergic conjunctivitis, perennial allergic conjunctivitis, and vernal keratoconjunctivitis (inflammation of the cornea and conjunctiva).

2. What you need to know before using Tilavist

Do not use Tilavist

• if you are allergic (hypersensitive) to nedocromil sodium or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Tilavist.

Before using this medication, inform your doctor:

• if you use soft contact lenses (see the section "Tilavist contains benzalkonium chloride").

Children

This medication is not recommended for use in children under 6 years of age.

Other medications and Tilavist

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

The concomitant administration of Tilavist with another solution containing metal ions (silver nitrate, zinc sulfate, or calcium or magnesium salts) may cause the formation of insoluble salts that would induce precipitates. To avoid this, the two preparations should be administered with a minimum interval of 5 minutes.

Pregnancy and breastfeeding

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

This medication will only be administered during pregnancy if your doctor considers it necessary.

The use of this medication is not recommended during breastfeeding.

Driving and using machines

You may experience blurred vision immediately after applying Tilavist. Do not drive or use machines until this effect has disappeared.

Tilavist contains benzalkonium chloride

This medication contains 0.1 mg of benzalkonium chloride per ml of solution.

Benzalkonium chloride can be absorbed by soft contact lenses, altering their color. Remove your contact lenses before using this medication and wait 15 minutes before putting them back in.

Benzalkonium chloride can cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer on the front of the eye). Consult your doctor if you feel any unusual sensation, itching, or pain in the eye after using this medication.

3. How to use Tilavist

Follow your doctor's instructions for administering this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Seasonal and perennial allergic conjunctivitis

Adults and children over 6 years of age

The recommended dose is one drop in the affected eye(s) twice a day. If your doctor considers it necessary, the dose may be increased to one drop in each eye up to four times a day.

Vernal keratoconjunctivitis

Adults and children over 6 years of age

The recommended dose is one drop in the affected eye(s) four times a day.

Be careful when squeezing the bottle, so that only one drop is introduced into the affected eye.

Use in children

This medication is not recommended for administration to children under 6 years of age.

This medication is for ophthalmic use only (eye drops).

Instructions for use

To administer Tilavist properly, follow these steps:

1. If you wear contact lenses, remove them before applying Tilavist. Do not put them back in until 15 minutes after applying Tilavist.
2. Wash your hands and stand in front of a mirror.

1. Remove the cap.
2. Tilt your head back. Using your finger, gently separate the lower eyelid of the eye to be treated.

1. Place the tip of the bottle close to the eye. To help prevent infections, avoid touching the tip of the bottle to the eye or any other surface.
2. Gently squeeze the bottle so that only one drop is introduced into the eye. Remove your finger from the lower eyelid.

1. Press the corner of the affected eye, near the nose, with your finger. Apply pressure for 1 minute, keeping your eye closed. This helps prevent Tilavist from entering the rest of the body.

1. Repeat the operation in the other eye, if your doctor has indicated it.
2. Replace the cap on the bottle.

If a drop falls outside the eye, try again.

If you are using other eye medications, wait at least 5 minutes between administering this medication and other eye medications. Ophthalmic ointments should be administered last.

If you use more Tilavist than you should

Be careful when squeezing the bottle, so that only one drop is introduced into the affected eye. If you apply too many drops to the eye, you may feel mild irritation.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20.

If you forget to use Tilavist

If you forget to apply a dose, apply it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular routine.

Do not apply a double dose to make up for missed doses.

If you interrupt treatment with Tilavist

Your doctor will indicate the duration of treatment. You should use the medication regularly to ensure optimal control of symptoms. Do not interrupt treatment without consulting your doctor first.

If you have any further questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The following side effects have been observed with the use of this medication:

Common side effects (may affect up to 1 in 10 patients)

• Mild local irritation (burning or foreign body sensation)
• Characteristic taste

Rare side effects (may affect up to 1 in 1,000 patients)

• Local irritation symptoms.

If you consider any of the side effects you are experiencing to be serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tilavist

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

Store below 25°C. Keep the bottle in the outer packaging to protect it from light.

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

Discard the bottle 28 days after opening it for the first time, even if there is still product inside.

Do not use Tilavist if you notice that the bottle seal is broken before the first use.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Tilavist

• The active ingredient is nedocromil sodium. 1 ml of solution contains 20 mg of nedocromil sodium. One drop of solution contains approximately 1 mg of nedocromil sodium.
• The other components are benzalkonium chloride, sodium edetate, sodium chloride, and purified water.

Appearance of the product and package contents

Tilavist is presented in a sterile bottle with a dropper and a seal. Each bottle of Tilavist contains 5 ml of eye drop solution.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teofarma S.R.L.

Via Fratellli Cervi, 8

I-27010 Valle Salimbene (Pavia)

Italy

Manufacturer

Bruschettini S.R.L.

Vía Isonzo, 6

I-16147 Genoa

Italy

Date of the last revision of this package leaflet:12/2021

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).