Prospect:information for the user

Oculotect 50 mg/ml eye drops solution

Povidone K25

Read this prospect carefully before starting to use this medicine, as 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.
• If you 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 improve after 3 days.

Contents ofthe prospect:

1.What Oculotect is and for what it is used

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

3.How to use Oculotect

4.Possible adverse effects

5.Storage of Oculotect

6.Contents of the package and additional information

Oculotect contains the active ingredient povidone K25. Oculotect is an eye drop for humidifying and lubricating the eyes. It is used to relieve symptoms of dry eye.

You should consult a doctor if it worsens or does not improve after 3 days.

Do not use Oculotect

If you are allergic to povidone K25 or any of the other components of this medication (listed in section 6). If you think you may be allergic, do not use this medication without first discussing it with your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Oculotect eye drops.

If you experience headache, eye pain, changes in vision, eye irritation, persistent redness, or if symptoms worsen or persist, discontinue treatment with Oculotect eye drops and consult your doctor.

Using Oculotect with other medications

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

If you need to apply another medication to your eyes in addition to Oculotect, wait at least 5 minutes between applications of each product. Oculotect should always be applied last.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication. Oculotect can be used during pregnancy and breastfeeding.

Driving and operating machinery

Oculotect may cause blurred vision. If this occurs, wait until the symptom disappears before driving or operating machinery.

Oculotect contains benzalkonium chloride

This medication contains 0.0018 mg of benzalkonium chloride in each drop equivalent to 0.05 mg/ml.

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

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 experience an unusual sensation, burning, or pain in the eye after using this medication.

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

The usual dose is one drop in the eye four times a day or as often as necessary.

If a drop falls outside the eye, try again.

If you use more Oculotect than you should,do not expect any adverse effects.

If you are using other eye medications,wait at least 5 minutes between the administration of this eye drop and the other eye medications. Oculotect should be administered last.

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

Instructions for use

1.Wash your hands.

2.Open the bottle. Do not touch the tip of the dropper after opening the bottle as it may contaminate the solution.

3.Incline your head backward (Fig.1).

4.Pull the lower eyelid down with your finger and hold the bottle with the other hand. The tip of the container should not come into contact with the eye as it may cause eye injury. Press the bottle so that a drop falls into the eye (Fig.2).

5.Close your eyes and press with a finger the inner angle of the eye for 1-2 minutes approximately. This prevents the drop from flowing down the tear duct into the throat, so that most of the drop remains in the eye (Fig.3). If necessary, repeat steps 3 to 5 with the other eye.

6.Close the bottle after use.

Fig.1Fig.2Fig.3

If you have any other questions about the use of this product, 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 reported:

Frequent (may affect up to 1 in 10 people)

-Mild and transient sensation of burning or itching in the eye (eyes)

Very Rare (may affect up to 1 in 10,000 people)

-Irritation

-Allergic reaction

Unknown Frequency(cannot be estimated from available data)

-Blurred vision, eye pain, eye itching, eye redness.

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 the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 25°C.

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

The bottle is not sterile, but its contents are sterile until the bottle is opened.

After the first opening of the bottle, the eye drops can only be stored for 4 weeks.

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

Medicines should not be disposed of through drains or in the trash. Dispose of 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 containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Oculotect

The active principle is povidone K25 . Each ml contains 50 mg of povidone K25.

The other components are benzalkonium chloride as a preservative, boric acid, calcium chloride, potassium chloride, magnesium chloride, sodium chloride, sodium lactate, sodium hydroxide to adjust pH, and water for injectable preparations.

Appearance of the product and content of the container

Oculotect is a transparent, slightly yellowish aqueous solution. The solution is presented in a container that contains a 10 ml vial.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Alcon Healthcare, S.A.

World Trade Center Almeda Park

Plaça de la Pau s/n, Edificio 6, planta 3

08940 - Cornellà de Llobregat (Barcelona)

Responsible for manufacturing

EXCELVISION

Rue de la Lombardière, BP 131

Annonay Cedex, F-07100-France

or

Alcon Couvreur N.V.

Rijksweg 14

B-2870 Puurs

Belgium

or

Alcon Laboratories Belgium

Lichterveld 3

2870 Puurs-Sint-Amands

Belgium

This medicine is authorized in the member states of the European Economic Area with the following names:

Denmark Oculac (MDU)

Finland Oculac (MDU)

Portugal Oculotect (fluid)

Spain Oculotect 50 mg/ml eye drops in solution

Sweden Oculac

Last review date of this leaflet: November 2020.

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