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ACULAR 0.5% EYEDROPS

Active substance(s): KETOROLAC TROMETAMOL

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Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before using this medicine. Acular should not be used if you
are pregnant or are breast-feeding, unless your doctor recommends it.

ACULAR®

0.5% EYE DROPS /
KETOROLAC TROMETAMOL 0.5% EYE DROPS
(ketorolac trometamol)

Children

Acular should not be prescribed for use in children.

PATIENT INFORMATION LEAFLET

Driving and using machines

Acular may cause temporary blurred vision. Do not drive or use machinery until the symptoms have
cleared.

Your medicine is available using the names Acular 0.5% Eye Drops or Ketorolac Trometamol 0.5% Eye
Drops, but will be referred to as Acular throughout this leaflet.

Acular contains benzalkonium chloride

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

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.






3.

HOW TO USE ACULAR

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if
you are not sure. The recommended dose is 1 drop into the affected eye(s), 3 times a day,
starting 24 hours before surgery and continuing for up to 3 weeks after eye surgery.

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

If you wear contact lenses you should remove them prior to application and wait at least 15
minutes before reinsertion.
The preservative in Acular benzalkonium chloride, may cause eye irritation and can permanently
damage this type of lens. Acular is known to discolour soft contact lenses.
Avoid contact with soft contact lenses.

1.

WHAT ACULAR IS AND WHAT IT IS USED FOR

2.

Acular is used to prevent and relieve eye inflammation following surgery on the eye in adults.
Acular belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). The
active ingredient in Acular is ketorolac trometamol.

Instructions for use

2.

1.
2.
3.



WHAT YOU NEED TO KNOW BEFORE YOU USE ACULAR

Do not use Acular




If you are allergic to ketorolac, or any of the other ingredients of this medicine
(listed in section 6).
If you are allergic to aspirin or any other similar drugs.

4.

3.

4.

You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first
use it. Apply your eye drops in the following way:
Wash your hands. Tilt your head back and look at the ceiling.
Gently pull the lower eyelid down until there is a small pocket.
Turn the bottle upside down and squeeze it to release one drop into each eye that needs
treatment.
Let go of the lower lid, and close your eye for 30 seconds.

If a drop misses your eye, try again.

Warnings and precautions

If any of the following apply talk to your doctor before using Acular.
If you suffer from, or have in the past suffered from,

viral or bacterial infections of the eye

bleeding tendencies (for example, anaemia) or stomach ulcers

diabetes

rheumatoid arthritis

dry eye syndrome

asthma after using non-steroidal anti-inflammatories

or if you have had recent eye surgery.

To avoid contamination or injury, do not let the tip of the dropper touch your eye or anything else.
Replace and tighten the cap straight after use.
Wipe off any excess liquid from your cheek with a clean tissue.
The proper application of your eye drops is very important. If you have any questions ask your doctor
or pharmacist.

If you use more Acular than you should

The application of too many drops is unlikely to lead to unwanted side effects. Apply your next dose at
the normal time. If, by accident, anyone drinks this medicine, drink fluids to dilute and contact your
doctor.

Other medicines and Acular

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicine,
including medicines obtained without a prescription.
If you use Acular with another eye medicine, leave at least 5 minutes between putting in Acular and
the other medicine.

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If you forget to use Acular

6.

If you forget a dose apply it as soon as you remember, unless it is almost time for your next dose, in
which case you should miss out the forgotten dose. Then take your next dose as usual and continue
with your normal routine.

Its active ingredient is: ketorolac trometamol 0.5% w/v. It also contains: sodium chloride,
benzalkonium chloride, edetate disodium, octoxynol 40, sodium hydroxide and hydrochloric acid
(to adjust pH) and purified water.

Do not take a double dose to make up for a forgotten dose.

What Acular looks like and contents of the pack

If you stop using Acular

Acular is a clear, colourless, sterile solution contained in a plastic dropper bottle.
Each bottle contains 5ml of the medicine.

Acular should be used as advised by your doctor. If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Acular contains

Manufacturer

POSSIBLE SIDE EFFECTS

Your medicine is manufactured by: Allergan Pharmaceuticals Ireland, Westport, Co. Mayo, Ireland.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Procured within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.

Side 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 topical steroid drops at the same time or if you have a
related eye condition. You should see your doctor immediately if you experience pain, increased
irritation in the eye or changes in vision.

Product Licence holder: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
PLPI: 04423/0415

The very common side effects (occurring in more than 1 in 10 patients) are: irritation of the

POM

eye, stinging and/or burning in the eye, eye pain.

Leaflet revision and issue date (Ref): 09.12.14

Common side effects (occurring in between 1 and 10 patients in every 100) are: allergic reaction,

To request a copy of this leaflet in Braille, large print or audio please call 01302 365000 and ask for
the regulatory Department.

eye and/or eyelid swelling/puffiness, itchy eyes, red eye, infection of the eye, inflammation of the eye
(surface or inside), bleeding of the retina, swelling of central retina (light-sensitive layer of the eye),
headache, accidental injury caused by the tip of the dropper touching the eye, increased pressure in
the eye, blurred and/or diminished vision.

Please be ready to give the following information:
Product Name:
Acular 0.5% Eye Drops/Ketorolac Trometamol 0.5% Eye Drops
Reference number:
04423/0415

Uncommon side effects (occurring in between 1 and 10 patients in every 1,000) are:

ACULAR® is a registered trademark of Allergan Inc.

inflammation or damage to the front clear layer of the eye, eye dryness and/or watery eyes.

Not known side effects (cannot be estimated from the available data) are: damage on the

surface of the eye such as thinning, erosion, degradation of cell(s), difficulty in breathing or wheezing,
aggravation of asthma.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5.








HOW TO STORE ACULAR

Keep the medicine in a safe place out of the sight and reach of children.
Store the medicine at room temperature.
The product should not be used after the expiry date (this is printed on both the label on the bottle
and on the bottom of the carton that the bottle is packed in). The expiry date refers to the last day
of the month.
Throw the bottle away 15 days after opening, even if there is solution remaining.
If your medicine appears to be discoloured or shows any other signs of deterioration, please return
to your pharmacist who will advise you further.
If your doctor tells you to stop taking the medicine, please take it back to the pharmacist for safe
disposal. Only keep the medicine if your doctor tells you to.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help to protect the environment.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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