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Active substance(s): KETOROLAC TROMETAMOL

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Insert - ACULAR® - Great Britain - MOH Submission

Information for the user


0.5% (w/v) Eye Drops, Solution
Ketorolac trometamol
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.
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

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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.

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 or pharmacist. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via:
Yellow Card Scheme

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. Wash your hands. Tilt your head back and look at the ceiling.
2. Gently pull the lower eyelid down until there is a small pocket.
3. Turn the bottle upside down and squeeze it to release one drop into each eye that
needs treatment.
4. 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.

By reporting side effects you can help provide more information on the safety of this
5. How to store ACULAR
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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
Store below 25°C.
Do not use this medicine if you notice the tamper-proof seal is broken.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help protect the environment.
6. Contents of the pack and other 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 3 ml, 5 ml or 10 ml 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,
Bucks, SL7 1YL
Tel: 01628 494026
Fax: 01628 494057
Allergan Pharmaceuticals Ireland,
Co. Mayo,
This leaflet was last revised in 09/2014

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.


© 2014 Allergan, Inc., Irvine CA 92612
® Marks owned by Allergan, Inc.

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