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ACULAR TOPICAL OPHTHALMIC SOLUTION

Active substance(s): KETOROLAC TROMETAMOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®
ACULAR 0.5% EYE DROPS
ACULAR® TOPICAL OPHTHALMIC SOLUTION
(ketorolac trometamol)
This product is available using any of the above names but will be referred to as Acular throughout the
following leaflet.
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.
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. WHAT ACULAR IS AND WHAT IT IS USED FOR
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.
2. 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.
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.
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.
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.
Children
Acular should not be prescribed for use in children.
Driving and using machines
Acular may cause temporary blurred vision. Do not drive or use machinery until the symptoms have
cleared.
Acular contains benzalkonium chloride
• 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.
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.

Instructions for use
• 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:
1.
2.
3.
4.

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.
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.
If you forget to use Acular
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.
Do not take a double dose to make up for a forgotten dose.
If you stop using Acular
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. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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.
The very common side effects (occurring in more than 1 in 10 patients) are: irritation of the eye,
stinging and/or burning in the eye, eye pain.
Common side effects (occurring in between 1 and 10 patients in every 100) are: allergic reaction,
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.
Uncommon side effects (occurring in between 1 and 10 patients in every 1,000) are: 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, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
at: 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 out of the sight and reach of children.
• Do not store above 25°C.
• Throw the bottle away 15 days after opening, even if there is solution remaining
• Do not use the product if the tamper proof seal on the bottle is broken
• The product should not be used after the expiry date which is stated on the bottle label and the
bottom of the carton after the EXP. The expiry date refers to the last day of that month.
• If your doctor tells you to stop taking the eye drops, please take them back to the pharmacist for
safe disposal. Only keep the eye drops if your doctor tells you to.
• If the eye drops become discoloured or show signs of any deterioration, you should seek the advice
of your pharmacist.
• 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Acular contains
The name of the product is Acular 0.5% Eye Drops.
The active ingredient is: ketorolac trometamol 0.5ml w/v. It also contains: benzalkonium chloride,
disodium edetate, octoxynol 40, sodium chloride, sodium hydroxide or hydrochloric acid (to adjust pH)
and purified water.
What Acular looks like and contents of the pack
Clear, colourless solution. Each bottle contains 5ml of the medicine.
Acular belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
®
®
PL No: 15814/0237 Acular 0.5% Eye Drops / Acular Topical Ophthalmic Solution

POM

It is manufactured by: Allergan Pharmaceuticals Ireland, Westport, Co Mayo, Ireland and procured
from within the EU and repackaged by the Product Licence holder: OPD Laboratories Ltd, Unit 6
Colonial Way, Watford, Herts WD24 4PR.
Acular is a registered Trade Mark of Allergan, Inc.
Leaflet revision and issue date (Ref.): 04.12.2014.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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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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