ACULAR

Active substance: KETOROLAC TROMETAMOL

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Package leaflet:
Information for the user

ACULAR®

Ketorolac trometamol 0.5% (w/v)
Eye Drops, Solution
Read all of this leaflet carefully before you start using this medicine.

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. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Acular is and what it is used for
2. Before you use Acular
3. How to use Acular
4. Possible side effects
5. How to store Acular
6. Further 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.

Before you use ACULAR

Do not use Acular

If you are allergic (hypersensitive) to ketorolac, or any of the other ingredients
of Acular.
If you are allergic to aspirin or any other similar drugs.

Take special care with Acular
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.
Using other medicines
Please tell your doctor or pharmacist if you are using or have recently used 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 any medicine.
Acular should not be used if you are pregnant or might become 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.
Important information about some of the ingredients of Acular
72086MD354B



If you wear contact lenses you should remove them prior to application and wait
at least 15 minutes before reinsertion.

Common side effects (occurring in between 1 and 10 patients in every 100) are:
death of cells on the surface of the eye, allergic reaction, eye and/or eyelid swelling/
puffiness, irritation of the eye, itchiness, redness, infection of the eye, inflammation
of the eye.
Uncommon side effects (occurring in between 1 and 10 patients in every 1,000)
are: ulcer(s) on the surface of the eye, inflammation under the surface of the eye,
blurred and/or diminished vision, headache, eye dryness and/or an excess of tears,
inflammation of the iris.




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

2.

3.

4.

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, 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 product, ask your doctor or pharmacist.
4.

If any of the side effects become serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
5.

Always use Acular exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure. The usual 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.

1.

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.

Possible side effects

How to store ACULAR

Keep out of the reach and sight of children.
Do not use Acular after the expiry date which is stated on the bottle label and the
bottom of the carton after EXP. The expiry date refers to the last day of that month.
Throw the bottle away 28 days after opening, even if there is solution remaining.
Store below 25°C.
Do not use Acular if you notice the tamper-proof seal is broken.
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.

Further Information

What Acular contains

The active substance is Ketorolac trometamol 0.5% w/v

The other ingredients are benzalkonium chloride, disodium edetate,
octoxinol 40, sodium chloride, sodium hydroxide or hydrochloric acid
(to adjust pH) and purified water
What Acular looks like and contents of the pack
ACULAR is a clear, colourless to slightly yellow solution in a plastic bottle.
Each pack contains 1 plastic bottle with a screw cap. Each bottle is about half full
and contains 3ml, 5 ml or 10ml of the eye drops as written on the front of the pack.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Allergan Limited,
Marlow International,
The Parkway,
Marlow,
Bucks, SL7 1YL
Tel: 01628 494026
Fax: 01628 494057
uk_medinfo@allergan.com
Manufacturer
Allergan Pharmaceuticals Ireland,
Westport,
Co. Mayo,
Ireland
This leaflet was last approved in 01/2013

Side effects related to the cornea (the surface of the eye) may be more likely
if Acular is used for longer than two weeks. You should see your doctor immediately
if you experience pain, increased irritation in the eye or changes in vision.

To listen to or request a copy of this leaflet in Braille, large print or audio
please call, free of charge: 0800 198 5000 (UK only).
Please be ready to give the following information: Ketorolac 0.5% reference
number PL 00426/0082.
This is a service provided by the Royal National Institute of Blind People.

The very common side effects (occurring in more than 1 in 10 patients) are:
stinging and/or burning in the eye, eye pain.

© 2011 Allergan, Inc., Irvine CA 92612
® Marks owned by Allergan, Inc.

Like all medicines, Acular can cause side effects, but not everyone gets them.

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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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