Acular 5 mg/ml eye drops solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

ACULAR 5 mg/ml eye drops, solution

(ketorolac tromethamine)

Read the entire leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if these effects are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What ACULAR is and what it is used for
2. What you need to know before using ACULAR
3. How to use ACULAR
4. Possible side effects
5. How to store ACULAR
6. Contents of the pack and other information

1. What ACULAR is and what it is used for

ACULAR is used to prevent and reduce ocular inflammation following cataract surgery in adults.

ACULAR belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).

2. What you need to know before using ACULAR

Do not use ACULAR

• If you are allergic to ketorolac tromethamine or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to aspirin or to other similar medicines, such as other non-steroidal anti-inflammatory drugs.

Warnings and precautions

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

If you have or have previously had:

• Bacterial or viral eye infections
• A tendency to bleed (e.g., anemia) or stomach ulcers
• Diabetes
• Rheumatoid arthritis
• Dry eye syndrome
• Asthma after taking non-steroidal anti-inflammatory drugs
• Recent eye surgery
• Reduced corneal sensitivity (the transparent layer covering the pupil and iris) or damage to the normally smooth corneal surface

Children and adolescents

ACULAR should not be prescribed for use in children.

Tell your doctor or pharmacist if you are using or have recently used, or might need to use, any other medicines.

If you use ACULAR together with any other eye medication, wait at least 5 minutes between applying ACULAR and the other medicine.

Pregnancy and breastfeeding

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

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

Driving and using machines

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

ACULAR contains benzalkonium chloride

This medicine contains 0.1 mg of benzalkonium chloride per milliliter, equivalent to 0.1 mg/ml.

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

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or eye pain after using this medicine.

3. How to use ACULAR

Follow exactly the administration instructions for ACULAR given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. The recommended dose is one drop into the affected eye three times a day for 3–4 weeks after cataract surgery, starting 24 hours before surgery.

Instructions for use

Apply the eye drops as follows:

1. Wash your hands. Tilt your head backwards and look up at the ceiling.

2. Gently pull down the lower eyelid until a small pocket is formed.

3. Turn the container upside down and squeeze it to release one drop into each eye requiring treatment.

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

If a drop misses the eye, repeat the procedure.

To avoid contamination or injury, do not let the tip of the container 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.

Correct application of your eye drops is very important.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

If you use more ACULAR than you should

Applying excess drops is unlikely to cause unwanted adverse effects. Apply your next dose at the usual time. If someone accidentally swallows this medicine, drink fluids to dilute it and contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20.

It is recommended to bring the package leaflet and medicine 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 that case, skip the missed dose. Apply your next dose at the usual time and continue with your regular dosing schedule. Do not use a double dose to make up for forgotten doses.

If you stop using ACULAR

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Very common (may affect more than 1 in 10 people):

• Eye irritation
• Itching and/or burning sensation in the eye
• Eye pain

Common (may affect up to 1 in 10 people):

• Allergic reaction
• Swelling/inflammation of the eye or eyelid
• Itchy eyes
• Red eye
• Eye infection
• Inflammation of the eye (surface or inside)
• Formation of small deposits on the transparent layer at the front of the eye
• Bleeding of the retina
• Inflammation of the central retina (light-sensitive layer of the eye)
• Headache
• Injury caused accidentally by contact between the dropper and the eye
• Increased pressure in the eye
• Blurred and/or reduced vision

Uncommon (may affect up to 1 in 100 people):

• Inflammation or damage to the transparent layer at the front of the eye
• Dry eye and/or watery eyes

Frequency not known (frequency cannot be estimated from available data):

• Damage to the surface of the eye, such as thinning
• Erosion
• Perforation
• Degradation of cell(s)
• Difficulty breathing or wheezing
• Worsening of asthma
• Facial inflammation
• Ulcer on the surface of the eye

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

Reporting of 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 leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ACULAR

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

Do not use this medicine after the expiry date stated on the container label and the carton after EXP (which corresponds to the English abbreviation for expiration). The expiry date refers to the last day of the month indicated.

Discard the medicine 28 days after opening, even if some solution remains.

Do not store above 25 °C.

Do not use this medicine if the tamper-evident seal is broken.

Medicines should not be disposed of via wastewater or household waste. Return empty containers and unused medicines to the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of ACULAR

• The active substance is ketorolac trometamol 5 mg/ml.
• The other components are benzalkonium chloride, disodium edetate, octoxynol 40, sodium chloride, sodium hydroxide or hydrochloric acid (to adjust pH), and purified water (see section 2).

Appearance of the product and contents of the pack

ACULAR is a clear, colourless to slightly yellowish ophthalmic solution in a plastic container.

Each pack contains 1 plastic bottle with a 10 ml capacity fitted with a screw cap.

Each pack contains 5 or 10 millilitres of solution.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

AbbVie Spain, S.L.U.

Avenida de Burgos 91

28050, Madrid

Spain

Manufacturer:

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

County Mayo

Ireland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: 04/2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

To request a copy of this leaflet in large print, please contact the local representative of the marketing authorization holder.