Prospect: informationfor the user

Centilux 0.25 mg/ml eye drops in solution

Nafazolina

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

Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your doctor or pharmacist.

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• Ifyou experience adverse effects, consult your doctor or pharmacist,even if they are not listed in this prospect. See section 4.
• You should consult a doctor if it worsens or does not improveafter 3 days.

1.What isCentilux eye dropsand what is it used for

2.What you need to knowbeforestarting touseCentilux eye drops

3.How to useCentilux eye drops

4.Possible adverse effects

5Storage ofCentilux eye drops

6.Contents of the package andadditional information

It contains nafazolina as the active ingredient, with decongestant action (produces vasoconstriction or narrowing of visible blood vessels in the eye).

Centilux is indicated for:Temporary relief of mild congestion, redness, and irritation in the eyes of irritative and/or allergic origin, caused by external agents such as: tobacco smoke, dust, pollution, dry or humid environments, sunlight, chlorinated or seawater, reading, or work that requires prolonged visual fixation.

Do not useCentilux:

• if you are allergic tonaphazoline or other adrenergic medications (which, among other actions, may elevate blood pressure)or to any of the other components ofthis medication (listed in section 6).
• if you have narrow-angle glaucoma.

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:

- If you are being administered certain anesthetics (e.g., halothane, which makes the heart more sensitive to medications like naphazoline)

- If you have bronchial asthma

- If you have any heart or circulation disease

- If you have cerebral arteriosclerosis

- If you have high blood pressure

- If you have thyroid disease

- If you have diabetes

- If you are being treated with MAO inhibitors (monoamine oxidase inhibitors) (usually antidepressants) or within two weeks of stopping this treatment

- Do not use for more than 3 to 5 days

- Do not use contact lenses during the use of this medication.

Children

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

Older adults

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

Other medications and Centilux

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

No interactions with other medications are known.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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 operating machinery

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

Centilux contains benzalkonium chloride and phosphates

This medication contains 0.1 mg of benzalkonium chloride in each ml.

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

Remove contact lenses before using this medication and wait at least 15 minutes before reinserting them.

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

This medication contains 2.2 mg of phosphates in each ml.

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

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist.Ask your doctor or pharmacist if you are unsure.

The recommended dose is:

Ocular administration (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, if possible, in front of a mirror.

2. After opening the dropper bottle (container) for the first time, remove the plastic ring from the seal.

3.Always be careful not to touch anything with the tip of the dropper, as it may contaminate the contents of the bottle.

4. Hold the bottle upside down with one hand.

5. With the other hand, separate the lower eyelid of the affected eye and direct your gaze upwards, tilting your head backwards.

6. Place the tip of the dropper close to the eye, but do not touch it, and gently press the base of the container to allow the drops to fall into the space between the eye and the eyelid.

7. Close your eyes gently and keep them closed for a few seconds.

8. Repeat steps 4, 5, and 6 for the other eye, if necessary.

9. Close the bottle tightly after use.

If you use more than one eye medication, 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 symptoms do not resolve within this time period (72 hours), consult your doctor, who will examine the condition of your eyes.

If you use more Centilux than you should

Due to the characteristics of this medication, it is not expected to experience symptoms of intoxication with topical use at the recommended doses.

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 container, especially in children, symptoms of central nervous system (CNS) impairment may appear, such as significant sedation, CNS depression, decreased body temperature, and coma.

With very high doses of naphazoline, cardiovascular or circulatory effects may occur.

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

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

If you forgot to use Centilux

Do not use a double dose to compensate for the missed 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 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 may experience them.

It has been observed that it could cause: pupil dilation, increased pressure within the eye (intraocular), effects due to absorption into the body (increased blood pressure, cardiac disorders, and increased blood sugar), headaches, and nausea.

In rare occasions, itching after application has been observed.

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

Unknown frequency: conjunctivitis, eye pain.

In very rare occasions: opaque areas in the cornea.

In predisposed patients and with the use of a greater quantity or frequency than recommended, palpitations, tremors, weakness, and sweating could be produced.

Also, an allergic reaction to one of the components could occur.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://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.

Do not store above 25°C.

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

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

Do not use this medication if you observe that the solution changes color or becomes turbid.

You must discard the bottle four weeks after the first opening.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you do not need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you do not need. In this way, you will help protect the environment.

Composition of Centilux

- The active ingredient isnafazolina hydrochloride.One ml of eye drops contains 0.25 mg of nafazolina hydrochloride (0.025%).

- The other components are: benzalkonium chloride, sodium chloride, disodium phosphate dodecahydrate, monosodium phosphate monohydrate, methylthioninium chloride (methylene blue) and purified water.

Appearance of the product and contents of the packaging

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

It is presented in a dropper bottle (plastic bottle) with10 ml of eye drop solution.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Reva Health Europe, S.L.

Pl. Ausiàs March,1, 4-6

08195 Sant Cugat del Vallès-Spain

Responsible for manufacturing

Tubilux Pharma S.P.A

VIA COSTA RICA, 20/22

00071-POMEZIA (ROMA)

Last review date of this leaflet:August 2016

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