Prospecto:Information for the User

ACUOLENS 3 mg/ml + 5.5 mg/ml Eye Drops in Single-Use Vial

Hypromellose / Sodium Chloride

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

Follow exactly the medication administration instructions contained in this prospectus or those indicated by your doctor or pharmacist.

• Keep this prospectus, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 3 days.

1. What is ACUOLENS and what is it used for?

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

3. How to use ACUOLENS

4. Possible adverse effects

5. Storage of ACUOLENS

6. Contents of the package and additional information

ACUOLENS is an eye drop that, due to its components, hypromellose and sodium chloride, lubricates and protects the cornea, relieving any discomfort (dryness and irritation) caused by a decrease in tear production.

It is used for symptomatic relief of eye irritation and dryness.

Consult a doctor if it worsens or does not improve after 3 days.

Do not use ACUOLENS

• if you are allergic to hypromellose, sodium chloride or any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

Consult your doctor or pharmacist before starting to use ACUOLENS.

Only use this medicine in your eye(s).

If you experience headache, eye pain, changes in vision, eye irritation, persistent redness or if symptoms worsen or last more than 3 days, discontinue treatment and consult your doctor.

Children

No specific studies have been conducted in children. Consult your doctor before using this medicine in children.

Other medicines and ACUOLENS

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

Pregnancy, breastfeeding and fertility

Consult your doctor before using any medicine.

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

This medicine may be used during pregnancy and breastfeeding

Driving and operating machines

Like other eye drops, you may experience blurred vision immediately after application of this medicine. Do not drive or use machines until your vision is clear.

ACUOLENS contains phosphate buffer

This medicine contains 2 mg of phosphates in each 0.5 ml.

If you suffer from severe corneal damage (the transparent layer at the front of the eye), treatment with phosphates, in rare cases, may cause blurred vision due to calcium accumulation.

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

The recommended dose is:

Adults (including elderly patients)

Instill 1 or 2 drops in each affected eye, as often as necessary.

The number of daily applications and the duration of treatment may be modified according to medical criteria.

Usage recommendations:

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1. Open the aluminum foil packet and take out the single-dose strip.
2. Hold the strip with the smooth long end facing upwards and separate one of the single-dose units by pulling it towards you while keeping the others firmly in place. You will have to remove the points where it is attached to the other units (figure 1).
3. Keep the separated single-dose unit. Put the rest of the single-dose units back in the aluminum foil packet.
4. Make sure you have a mirror and wash your hands.
5. Hold the smooth long end of the single-dose unit between your fingers and open it by turning the other end (figure 2).
6. Tilt your head back. Gently separate your lower eyelid from your eye with a finger, until a pouch forms, in which the drop should fall (figure 3).
7. Hold the single-dose unit between your fingers with the open end facing downwards.
8. Bring the tip of the container close to your eye. A mirror may be helpful.
9. Do not touch your eye, eyelid, nearby areas, or other surfaces with the tip of the container. The drops may become contaminated.
10. Press the container gently to allow a drop to fall into the pouch formed between the eyelid and the eye.
11. If drops are applied to both eyes, repeat the previous steps for the other eye, using the same container.
12. Dispose of the container and any remaining solution immediately.
13. Dispose of any unused container one week after opening the aluminum foil packet, even if the containers are still unopened.

If a drop falls outside the eye, try again.

If you are using other eye medications, wait at least 5 minutes between administering this eye drop and the other eye medications. Eye ointments should be administered last.

If you use more ACUOLENS than you should,you can remove it by rinsing your eyes with warm water.

Due to the characteristics of this preparation, it is not expected to have intoxication phenomena with the ocular use of the product.

In case of overdose or accidental ingestion, consultyour doctor immediately or callthe Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forgot to use ACUOLENSdo not worry, apply the drops as soon as possible. Do not apply a double dose to compensate for the missed doses.

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.

Observed Adverse Effects.

Unknown Frequency(frequency cannot be estimated from available data):

• Eye Effects: Blurred vision, eye pain, abnormal sensation in the eye, eye irritation, eye redness, eye allergy, and itchy eyes
• Body Effects: Allergic reaction (hypersensitivity)

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 about the safety of this medication.

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

No special storage conditions are required.

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

You must discard the single dose as soon as you have used it.Once the aluminum foil packet is opened, discard unused single doses one week after opening.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and unused medications at thePharmacyTakeBackSiteofyour pharmacy. If in doubtask your pharmacist how to dispose of unused containers and medications. By doing so, you will help protect the environment.

Composition of ACUOLENS

• The active principles are hypromellose and sodium chloride. One milliliter of solution contains 3mg of hypromellose and 5.5 mg of sodium chloride.
• The other components are potassium chloride, magnesium chloride hexahydrate, calcium chloride dihydrate, zinc chloride, disodium dodecahydrogenophosphate, monobasic sodium phosphate monohydrate, sodium hydrogen carbonate, and purified water.

Appearance of the product and contents of the packaging

This medication is a liquid (transparent and colorless) that is presented in a plastic box of 30 units of 0.5 ml.

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)

Spain

Responsible for manufacturing

Alcon-Couvreur N.V.

Rijksweg 14

B-2870 Puurs

Belgium

or

Alcon Laboratories Belgium

Lichterveld 3

2870 Puurs-Sint-Amands

Belgium

Last review date of this leaflet: August 2022

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