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Active substance(s): KETOROLAC TROMETAMOL

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Package leaflet: Information for the user

Ketorolac Trometamol 0.5% w/v Eye Drops, solution

Ketorolac trometamol (Referred to as Ketorolac eye drops in this 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 or nurse.
- 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 or nurse.
This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Ketorolac eye drops is and what it is used for
2. What you need to know before you use Ketorolac eye drops
3. How to use Ketorolac eye drops
4. Possible side effects
5. How to store Ketorolac eye drops
6. Contents of the pack and other information

If you use more Ketorolac eye drops 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 anyone drinks this medicine they should drink fluids to dilute the
medicine in the stomach and contact their doctor for advice.

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


Do not use Ketorolac eye drops
• If  you are allergic (hypersensitive) to ketorolac, or any of the other ingredients of
this medicine (listed in section 6).
• If  you are allergic (hypersensitive) to aspirin (acetylsalicylic acid) or other non-steroidal
anti-inflammatory drugs (NSAIDs).
• in  children or adolescents under the age of 18 years
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Ketorolac eye drops if any of the following
apply to you:
You have, or have had in the past,
• eye infections
• corneal damage
• a tendency to bleed easily
• A stomach ulcer
• diabetes
• rheumatoid arthritis
• dry eyes
• asthma after using non-steroidal anti-inflammatory drugs (NSAIDs)
• recent eye surgery
You should also consult your healthcare professional first if you are using:

that thin the blood and reduce blood clotting (anticoagulants such as warfarin)
• medicines
• other non-steroidal anti-inflammatory drugs (NSAIDs)
Ketorolac eye drops contain the preservative benzalkonium chloride which
may cause irritation and discolours soft contact lenses.
If you are wearing soft contact lenses, these must be removed before
inserting the eye drops and they should not be replaced for at least
15 minutes afterwards.

Other medicines and Ketorolac eye drops
Tell your doctor or pharmacist or nurse if you are using, have recently used or might use any
other medicines including medicines obtained without a prescription.
If you use Ketorolac eye drops with another eye medicine, leave at least 5 minutes between
putting in Ketorolac eye drops and the other medicine.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Ketorolac eye drops may cause temporary blurred vision. Do not drive or use machinery until
your vision has cleared.

eye drops contain benzalkonium chloride as a preservative. If you wear contact
• Ketorolac
lenses you should remove them prior to application and wait at least 15 minutes before
 preservative in Ketorolac eye drops benzalkonium chloride, may cause eye irritation
• The
and can permanently damage this type of lens. Ketorolac eye drops is known to discolour
soft contact lenses.
• Avoid contact with soft contact lenses.
Always use this medicine exactly as your doctor or pharmacist has told you. 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.

If you stop using Ketorolac eye drops
Ketorolac Eye Drops 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 or
Like all medicines, Ketorolac eye drops can cause side effects, although not everybody gets
The most frequent side effect upon applying these drops is a temporary stinging or burning
sensation in the eye.
Very common side effects (affecting at least 1 in 10 users):
- irritation or burning sensation in the eye.
Common side effects (affecting 1 in 10 to 100 users):
- allergic reactions,
- the appearance of small grey bumps on the surface of the eye, with or without irritation
(inflammation) called superficial punctate keratitis

- eye pain or stinging
- eye and/or eyelid swelling/puffiness
- itching and/or redness of the eye
Rare side effects (affect 1 in 1000 to 10000 patients):
- headache
- ulceration of the surface of the eye (corneal ulceration)
- areas of irritation (inflammation) on the surface of the eye
(called corneal infiltrates)
- blurred and//or reduced vision
- dry eyes
- watering eyes
You should see your doctor immediately if you experience pain or decreased vision in
your eye.
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.

Ketorolac eye drops should not be prescribed for use in children.


If you forget to use Ketorolac eye drops
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 use a double dose to make up for a forgotten dose.


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.
Using the drops for the first time: These eye drops come in a bottle with a coned shaped nozzle
and screw cap. The inside of the screw cap contains a spike. The screw cap is fitted to the
bottle in such a way that there is no contact between the spike and the top of the nozzle of the

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 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.
This product does not require any special storage conditions.
Do not use Ketorolac eye drops if you notice the tamper-proof seal is broken.
Do not throw away any medicines via waste water or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help to protect the environment.
What Ketorolac eye drops contains
• The active substance is Ketorolac trometamol.
 other ingredients are benzalkonium chloride, edetate disodium,
• The
octoxynol 40, sodium chloride, sodium hydroxide or hydrochloric acid
(to adjust pH) and water for injection.
What Ketorolac eye drops looks like and contents of the pack
Ketorolac Eye drops is a clear, colourless to pale yellow solution practically free from particles
supplied in either a 3ml, 5ml or 10ml in white low density polyethylene (LDPE) container with
translucent LDPE block nozzle and white high density polyethylene HDPE screw caps.
Pack sizes: 1 x 3ml, 1 x 5ml, 3 x 5ml and 1 x 10ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Brown & Burk UK Ltd
5, Marryat Close,
Hounslow West,
TW4 5DQ,
Distributed by:
Aspire Pharma Ltd
Bellamy House, Winton Road
Hampshire, GU32 3HA
United Kingdom
This leaflet was last revised in 03/2013.
1010236 P1.8

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bottle. In order to open the bottle it is necessary to tighten the screw cap further, so that the
edge of the screw cap and the nozzle edge are totally aligned. At this point the screw cap spike
will pierce the top of the nozzle of the bottle, which will open the bottle. Once the bottle has
been opened in this way, unscrew the screw cap fully to remove it from the bottle and apply the
eye drops.
Apply your eye drops in the following way:
1. Wash your hands.
2. Tilt your head back and look at the ceiling
3. Gently pull the lower eyelid down until there is a small pocket
4. Turn the bottle upside down and squeeze it to release one drop into each eye that needs
5. 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.

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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.