Package Insert: Information for the User

ACULAR 5 mg/ml Eye Drops in Solution

(Ketorolaco trometamol)

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

- Keep this package insert as you may need to refer to it again.

- If you have any questions, consult your doctor, pharmacist, or nurse.

- This medication has been prescribed only for you and should not be given to others even if they have the same symptoms, as it may harm them.

-If you experience any adverse effects,consult your doctor, pharmacist, or nurse,evenifthey do not appear in this package insert. See section 4.

1. What is ACULAR and for what it is used

2. What you need to knowbeforestarting touseACULAR

3. How to use ACULAR

4. Possible adverse effects

5 Storage of ACULAR

6. Contents of the package and additional information

ACULAR is used to prevent and reduce eye inflammation after cataract surgery in adults.

ACULAR belongs to a group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs).

Do Not Use ACULAR

• If you are allergic to ketorolac tromethamine, or to any of the other components of this medication (listed in section 6).
• If you are allergic to aspirin or to other similar medications, such as other nonsteroidal anti-inflammatory drugs.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use ACULAR.

If you have or have had in the past:

• Ocular bacterial or viral infections
• Tendency to bleed (e.g., anemia) or stomach ulcers
• Diabetes
• Rheumatoid arthritis
• Dry eye syndrome
• Asthma after using nonsteroidal anti-inflammatory drugs
• Recent eye surgery.
• Loss of sensitivity in the cornea (the transparent layer that covers the pupil and iris) or damage to the smooth surface of the cornea.

Children

ACULAR should not be prescribed for use in children.

Use of ACULAR with other medications

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

If you use ACULAR with any other eye medication, leave at least 5 minutes between the administration of ACULAR and the other medication.

Pregnancy, breastfeeding, and fertility

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

ACULAR should not be used if you are pregnant or breastfeeding, unless your doctor recommends it.

Driving and operating machines

ACULAR may cause blurred vision in some patients. Do not drive or operate machines until symptoms have disappeared.

ACULAR contains benzalkonium chloride

This medication contains 0.1 mg of benzalkonium chloride in each milliliter, equivalent to 0.1 mg/ml.

Benzalkonium chloride can 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 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.

Follow exactly the administration instructions for ACULAR as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. The recommended dose is one drop in the affected eye three times a day for 3-4 weeks after cataract surgery, starting 24 hours before the operation.

Usage Instructions

Apply the eye drops as follows:

1. Wash your hands before opening the container. Tilt your head back and look up towards the ceiling.

2. Gently pull down the lower eyelid until a small space is created.

3. Turn the container upside down and press it to release one drop into each eye that needs treatment.

4. Release the lower eyelid and keep the eye closed for 30 seconds.

If a drop falls outside the eye, repeat the procedure.

To avoid contamination or injury, do not allow the tip of the container to touch the eye or any other surface.

Replace the cap and close the container immediately after use.

Wipe away any excess liquid from your cheek with a clean tissue.

It is very important to apply your eye drops correctly.

If you have any doubts, consult your doctor or pharmacist.

If you use more ACULAR than you should

The application of an excess of drops is unlikely to cause any undesirable side effects. Apply your next dose at the usual time. If by accident, someone ingests this medication, drink liquids to dilute and consult immediately your doctor or pharmacist or call the Toxicological Information Service, phone 91 562 04 20.

It is recommended to bring the package insert and the medication container to the healthcare professional.

If you forget to use ACULAR

If you forget to use ACULAR, apply it as soon as you remember, unless it is almost time for your next dose, in which case skip the missed dose. Apply your next dose and continue with your regular schedule. Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with ACULAR

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

Like all medications, this medication may have adverse effects, although not everyone will experience them.

Very Frequent(may affect more than 1 in 10 people).

Eye irritation, itching and/or burning in the eye, eye pain.

Frequent(may affect up to 1 in 10 people)

Allergic reaction, swelling/inflammation of the eye or eyelid, eye itching, red eye, eye infection, eye inflammation (surface or interior), retinal hemorrhage, central retinal inflammation (photosensitive layer of the eye), headache, accidental injury caused by contact between the dropper and the eye, increased eye pressure, blurred and/or decreased vision.

Infrequent(may affect up to 1 in 100 people)

Inflammation or damage to the clear layer in the front of the eye, dry eye and/or watery eyes.

Unknown Frequency(frequency cannot be estimated from available data)

Damage to the eye surface, such as thinning, erosion, perforation, degradation of the cells; difficulty breathing or wheezing, worsening of asthma, facial inflammation, ulcer on the eye surface.

Adverse reactions related to the cornea (eye surface) may be more likely if ACULAR is used for more than two weeks or if you are using corticosteroid eye drops at the same time or if you have a related eye condition. You should consult your doctor if you experience pain, increased eye irritation, and changes in vision.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines 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 use this medication after the expiration date that appears on the label of the container and on the box after EXP (which corresponds to the English abbreviation for expiration date). The expiration date is the last day of the month indicated.

Dispose of the medication 28 days after opening, even if there is still some solution left.

Do not store at a temperature above 25 ° C.

Do not use this medication if you observe that the protective seal on the neck of the container is broken.

Medications should not be thrown away through drains or in the trash. Deposit the containers and medications that you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications that you do not need. In this way, you will help protect the environment.

Composition of ACULAR

• The active ingredient is Ketorolaco trometamol 5 mg/ml.
• The other components are benzalkonium chloride, disodium edetate, octoxinol 40, sodium chloride, sodium hydroxide or hydrochloric acid (to adjust the pH) and purified water.

Appearance of the product and contents of the container

ACULAR is a clear, colorless to slightly yellowish solution eye drop in a plastic container.

Each container contains 1 plastic vial of 10 ml capacity provided with a screw cap.

Each container contains 5 or 10 milliliters of solution.

Not all formats may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

AbbVie Spain, S.L.U.

Avenida de Burgos 91

28050, Madrid

Spain

Responsible manufacturer:

Allergan Pharmaceuticals Ireland

Westport

Co. Mayo

Ireland

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

Last review date of this leaflet:04/2019

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