TILAVIST 20 MG/ML EYE DROPS SOLUTION

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tilavist 20 mg/ml eye drops, solution

nedocromil sodium

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

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

Contents of the leaflet

1. What Tilavist is and what it is used for
2. What you need to know before using Tilavist
3. How to use Tilavist
4. Possible side effects
5. How to store Tilavist
6. Contents of the pack and other information

1. What Tilavist is and what it is used for

Tilavist is an eye drop solution containing the active substance nedocromil sodium, which inhibits the degranulation of sensitized mast cells, thereby preventing the release of histamine and other inflammatory mediators. This medicine is indicated in adults and children over 6 years of age for the symptomatic treatment of ocular conditions of allergic origin, 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 sodium nedocromil or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Tilavist.

Before using this medicine, inform your doctor:

• if you wear soft contact lenses (see section “Tilavist contains benzalkonium chloride”).

Children

The use of this medicine is not recommended in children under 6 years of age.

Other medicines and Tilavist

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

Concomitant administration of Tilavist with another solution containing metal ions (silver nitrate, zinc sulfate, or calcium or magnesium salts) may lead to the formation of insoluble salts causing precipitates. To avoid this, the two preparations should be administered at least 5 minutes apart.

Pregnancy and breastfeeding

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

This medicine should only be administered during pregnancy if your doctor considers it appropriate.

The use of this medicine is not recommended during breastfeeding.

Driving and using machines

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

Tilavist contains benzalkonium chloride

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

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

Benzalkonium chloride may cause eye irritation, particularly if you have dry eye or other corneal disorders (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or eye pain after using this medicine.

3. How to use Tilavist

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, 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 or eyes twice daily. 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 or eyes four times daily.

Be careful when squeezing the bottle so that only one drop enters the affected eye.

Use in children

This medicine is not recommended for children under 6 years of age.

This medicine is for ocular use only (ophthalmic use).

Instructions for use

To properly administer Tilavist, follow these steps:

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

1. Unscrew the cap.
2. Tilt your head backward. Using your finger, gently pull down the lower eyelid of the eye to be treated.

1. Place the tip of the bottle close to the eye. To help prevent infection, avoid letting the tip of the container touch the eye or any other surface.
2. Gently squeeze the bottle so that only one drop enters the eye. Remove your finger from the lower eyelid.

1. Press with your finger on the inner corner of the treated eye, near the nose. Apply pressure for 1 minute, keeping your eye closed. This helps prevent Tilavist from passing into the rest of the body.

1. Repeat the procedure in the other eye, if instructed by your doctor.
2. Replace the cap on the bottle.

If a drop falls outside the eye, try again.

If you are using other ophthalmic medicines, wait at least 5 minutes between administering this medicine and other ophthalmic medicines. 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 enters the affected eye. If too many drops are applied to the eye, you may experience mild eye irritation.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 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 schedule.

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

If you stop using Tilavist

Your doctor will advise you on the duration of treatment. You should use the medicine regularly to ensure optimal symptom control. Do not stop treatment without first consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.

The following adverse effects have been observed with the use of this medicine:

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

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

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

• Symptoms of local irritation

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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 leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Tilavist Storage

Keep this medicine 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 medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Discard the bottle 28 days after first opening, even if there is some product remaining inside.

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

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tilavist

• The active substance 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, edetate disodium, sodium chloride and purified water.

Appearance of the product and contents of the container

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teofarma S.R.L.

Via Fratelli Cervi, 8

I-27010 Valle Salimbene (Pavia)

Italy

Manufacturer

Bruschettini S.R.L.

Via Isonzo, 6

I-16147 Genoa

Italy

Date of the most recent revision of this leaflet: 12/2021

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