CENTILUX 0.25 mg/ml EYE DROPS SOLUTION

Introduction

Leaflet: informationfor the user

Centilux 0.25 mg/ml eye drops in solution

Nafazoline

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

Follow exactly the administration instructions of the medication contained in this leaflet or as 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.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days.

Contents of the leaflet

1. What Centilux eye drops are and what they are used for
2. What you need to know before starting to use Centilux eye drops
3. How to use Centilux eye drops
4. Possible side effects

5 Conservation of Centilux eye drops

1. Contents of the package and additional information

1. What Centilux eye drops are and what they are used for

They contain nafazoline as the active ingredient, with decongestant action (produces vasoconstriction or narrowing of the visible blood vessels in the eye).

Centilux is indicated for: Temporary relief of congestion, redness, and mild irritation in the eyes of irritative and/or allergic origin, caused by external agents such as: tobacco smoke, dust, pollution, dry or charged environments, sunlight, chlorinated or sea water, reading or tasks that require prolonged fixation of vision.

2. What you need to know before starting to use Centilux eye drops

Do not useCentilux:

• if you are allergic to nafazoline or other adrenergic medications (which, among other actions, can raise blood pressure) or to any of the other components of this medication (included in section 6).
• if you have narrow-angle glaucoma in the eyes.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Centilux.

You must be cautious if you are in any of the following cases:

• In case you are being administered certain anesthetics (e.g., halothane, which makes the heart more sensitive to medications of the nafazoline type)
• If you have bronchial asthma
• If you have any heart or circulation disease
• If you have arteriosclerosis in the brain
• If you have high blood pressure
• If you have thyroid disease
• If you have diabetes
• If you are being treated with MAOI (monoamine oxidase inhibitor) medications (usually antidepressants) or during the two weeks after stopping such treatment
• Do not use for more than 3 to 5 days
• Do not wear contact lenses during the use of this medication.

Children

Do not use Centilux in children; safety and efficacy have not been established in children.

Elderly patients

Caution should be exercised in patients over 65 years of age, particularly those with severe heart or circulation diseases.

Other medicationsand Centilux

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

No interactions with other medications are known.

Pregnancy and lactation

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.

Centilux should only be administered during pregnancy if it is considered absolutely necessary and the potential benefit outweighs the potential risk to the fetus.

Do not use Centilux if you are breastfeeding a baby.

Driving and using machines

This medication may cause temporary vision disturbances. Do not drive or operate machines for a few minutes until the blurry vision disappears.

Centilux contains benzalkonium chloride and phosphates

This medication contains 0.1 mg of benzalkonium chloride per ml.

Benzalkonium chloride can be absorbed by soft contact lenses and may alter their color.

Remove contact lenses before using this medication and wait at least 15 minutes before putting them back on.

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

This medication contains 2.2 mg of phosphates per ml.

If you have severe damage to the transparent layer on the front of the eye (cornea), treatment with phosphates, in very rare cases, can cause cloudy patches on the cornea due to calcium.

3. How to use Centilux eye drops

Follow exactly the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Ophthalmic route (in the eyes)

• Adults:

The dose is one or two drops of Centilux administered 2 to 4 times a day in the affected eye(s).

How to use:

1. Wash your hands and sit in front of a mirror, if possible.
2. After opening the dropper bottle (vial) for the first time, remove the plastic ring from the seal.
3. Always be careful not to touch anything with the dropper tip, as it could contaminate the contents of the vial.

Content of the vial.

1. Hold the vial upside down with one hand.
2. With the other hand, pull down the lower eyelid of the affected eye and look up, tilting your head back.

Direction of gaze.

1. Place the dropper tip close to the eye, without touching it, and gently press the base of the vial so that the drops fall into the space between the eye and the eyelid.

Application of the drops.

1. Gently close your eyes and keep them closed for a few seconds.
2. Repeat steps 4, 5, and 6 for the other eye, if necessary.
3. Close the vial well after use.

If you use more than one medication via the ophthalmic route, the applications should be spaced at least 5 minutes apart.

The duration of treatment should not exceed 3-5 days (rebound congestion may occur).

If the symptoms do not resolve within this time period (72 hours), you should consult a doctor who will examine the condition of your eyes.

If you use more Centilux than you should

Due to the characteristics of this medication, intoxication phenomena are not expected with topical use at the recommended doses.

Taking a considerably larger amount of Centilux than the recommended dose, for example, if you accidentally swallow Centilux, can cause serious side effects that affect the heart and blood circulation. Symptoms may include: reduced heart rate (bradycardia), acute headache, nausea, vomiting, respiratory problems, increased heart rate (tachycardia), and chest pain.

An overdose can be eliminated by rinsing the eyes with warm water. Do not apply more drops until it is time for the next dose.

In case of accidental ingestion of the contents of a vial, especially in children, signs of central nervous system (CNS) effects may appear, such as significant sedation, CNS depression, decreased body temperature, and coma.

With very high doses of nafazoline, side effects may occur in the heart or circulation.

Other symptoms that may appear if the medication is accidentally ingested, especially by children, are: nausea, vomiting, lethargy, difficulty breathing, etc.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service, Telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Centilux

Do not use a double dose to make up for the forgotten dose.

Apply a single dose as soon as you remember. If it is almost time for the next dose, wait for the next dose and continue with your regular regimen.

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

4. Possible side effects

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

It has been observed that the following may occur: dilation of the pupil, increased pressure inside the eye (intraocular), effects due to absorption into the body (increases in blood pressure, cardiac disorders, and increased blood sugar), headache, and nausea.

Rarely, itching has been observed after application.

Possible appearance, with low frequency, of continuous redness and eye irritation.

With unknown frequency: conjunctivitis, eye pain.

In very rare cases: opaque areas in the cornea.

In predisposed patients and with the use of a greater amount or frequency than recommended, palpitations, tremors, weakness, and sweating may occur.

An allergic reaction to one of the components may also occur.

Reporting of 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Centilux eye drops

Keep this medication out of sight and reach of children.

Do not store at a temperature above 25°C.

Keep the container in the outer packaging to protect it from light.

Do not use this medication after the expiration date shown on the container and carton after EXP. The expiration date is the last day of the month indicated.

Do not use this medication if you notice that the solution changes color or becomes cloudy.

The vial must be discarded four weeks after the first opening.

Medications should not be thrown down the drain or into the trash. Deposit the containers and medications you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Contents of the package and additional information

Composition of Centilux

• The active ingredient is nafazoline hydrochloride. One ml of eye drops contains 0.25 mg of nafazoline hydrochloride (0.025%).
• The other components are: benzalkonium chloride, sodium chloride, disodium phosphate dodecahydrate, sodium phosphate monohydrate, methylthioninium chloride (methylene blue), and purified water.

Appearance of the product and contents of the package

The medication is an eye drop solution; it is a blue liquid.

It is presented in a dropper bottle (plastic vial) with 10 ml of eye drop solution.

Marketing authorization holder and manufacturer

Marketing authorization holder

Reva Health Europe, S.L.

Pl. Ausiàs March, 1, 4-6

08195 Sant Cugat del Vallès-Spain

Manufacturer

Tubilux Pharma S.P.A.

VIA COSTA RICA, 20/22

00071-POMEZIA (ROMA)

Date of the last revision of this leaflet:June 2025

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/