ACULAR

Active substance: KETOROLAC TROMETAMOL

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Insert - ACULAR® - UK - MoH Submission

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
• 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.

Artwork created at 100%
Drop all keylines and notes before printing
Part Number: 72086MD098E
Drawing Number: 0106901

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.
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. How to store ACULAR
3. How to use ACULAR

Keep out of the reach and sight of children.

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.

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.

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4.

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

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.

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

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.

Manufacturer
Allergan Pharmaceuticals Ireland,
Westport,
Co. Mayo,
Ireland

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

This leaflet was last revised in 08/2013

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.

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.

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.

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.

© 2013 Allergan, Inc., Irvine CA 92612
® Marks owned by Allergan, Inc.

4. Possible side effects
Like all medicines, Acular can cause side effects, but not everyone 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.

72086MD098E

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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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