Prospect: information for the user

Tilavist 20 mg/ml eye drops in solution

nedocromil sodium

Read this prospect carefully before starting to use this medication, as it contains important information for you.

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

1.What is Tilavist and for what it is used

2.What you need to know before starting to use Tilavist

3.How to use Tilavist

4.Possible adverse effects

5.Storage of Tilavist

6.Contents of the package and additional information

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 inflammation mediators. This medication is indicated for adults and children over 6 years old for the symptomatic treatment of allergic eye conditions, such as seasonal allergic conjunctivitis, perennial allergic conjunctivitis, and vernal keratoconjunctivitis (inflammation of the cornea and conjunctiva).

Do not use Tilavist

- if you are allergic (hypersensitive) to nedocromil sodium or to any of the other ingredients 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 use soft contact lenses (see the section “Tilavist contains benzalkonium chloride”).

Children

This medicine is not recommended for children under 6 years old.

Other medicines and Tilavist

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

The simultaneous 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, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

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

This medicine is not recommended during breastfeeding.

Driving and operating machines

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

Tilavist contains benzalkonium chloride

This medicine contains 0.1 mg of benzalkonium chloride in each ml of solution.

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

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 your eye after using this medicine.

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

Seasonal and perennial allergic conjunctivitis

Adults and children over 6 years old

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

Vernal keratoconjunctivitis

Adults and children over 6 years old

The recommended dose is one drop in the affected eye or eyes four times a day.

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

Use in children

This medication is not recommended for children under 6 years old.

This medication is only for use in the eyes (ophthalmic route).

Instructions for use

To administer Tilavist properly, you must follow the following steps:

1.Remove your contact lenses before applying Tilavist. Do not put them back on until 15 minutes have passed since the application of Tilavist.

2.Wash your hands and stand in front of a mirror.

3.Remove the cap.

4.Incline your head back. Using your finger, gently separate the lower eyelid from the eye to be treated.

5.Place the tip of the bottle near the eye.To help prevent infections, avoid letting the tip of thebottle touch the eye, or any other surface.

6.Press the bottle carefully so that only one drop is introduced into the eye. Remove your finger from the lower eyelid.

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

8.Repeat the procedure in the other eye, if your doctor has indicated.

9.Replace the cap on the bottle.

If a drop falls outside the eye, try again.

When using other eye medications, wait at least 5 minutes between the administration of this medication and the other eye medications. Eye ointments should be administered last.

When using more Tilavist than you should

Be careful when pressing the bottle, so that only one drop is introduced into the affected eye. If too many drops are applied to the eye, you may feel a slight irritation in it.

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

When you forget to use Tilavist

If you forget to apply a dose, apply it as soon as you remember. But if it is close to the time to apply the next dose, you should omit the missed dose and continue with your regular routine.

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

When interrupting treatment with Tilavist

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

If you have any other doubts 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 adverse effects have been observed with the use of this medication:

Frequent Adverse Effects (may affect up to1 in 10 patients)

• Mild local irritation (burning or feeling of a foreign body)
• Characteristic taste

Rare Adverse Effects (may affect up to 1 in 1,000 patients)

• Symptoms of local irritation.

If you consider that 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:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

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

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.

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

Do not use tilavist if you observe that the bottle seal is broken before first use.

Medications should not be thrown down the drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tilavist

• The active principle 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 contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teofarma S.R.l.

Via Fratellli Cervi, 8

I-27010 Valle Salimbene (Pavia)

Italy

Responsible for manufacturing

Bruschettini S.R.L.

Vía Isonzo, 6

I-16147 Génova

Italy

Last review date of this leaflet:12/2021

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