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KETOROLAC TROMETAMOL 0.5% W/V EYE DROPS SOLUTION

Active substance(s): KETOROLAC TROMETAMOL / KETOROLAC TROMETAMOL

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MICRO LABS LIMITED
Bangalore, INDIA

Colours used

2) Strength

: Ketorolac Trometamol Eye Drops, Solution Aspire Pharma - UK
: 0.5% w/v

3) Component

: Leaflet

4) No. of Colours

: 02

5) Dimension

: 110 x 560 mm (Final Folding: 110 x 30 x 1.25 mm)

6) Artwork Code

: NA

7) Pharma Code

: NA

8) Font Type and Size

: Arial Narrow, 9 pt

1) Product

Pantone 185 C
Black

Colours not for Printing

Keylines

9) Technical Specification: NA
Code No. :

WOA
WA

Reason for Change
Approved
by

Contract Giver/
PL holder

Regulatory
Affairs

NA

Revision: 00

NA

Date : 10-01-2017
Packaging
Development

Head Production/
Packing (Site)

Head QC
(Site)

Head QA
(Site)

Sign/
Date

110 mm

110 mm

Pharmacode

6. To open the bottle, remove the cap by turning it in the counterclockwise direction
(Fig.6).

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)
Fig. 6

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.

Using your eye drops
7. Wash your hands, tilt your head back and look at the ceiling (Fig.7).

Fig. 7

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

8. Gently pull the lower eyelid down to form a small pocket between the eyelid and the
eye (Fig. 8).

Fig. 8

1. WHAT KETOROLAC EYE DROPS IS AND WHAT IT IS USED FOR
Ketorolac eye drops belong to a group of medicines known as non-steroidal antiinflammatory drugs (NSAIDs).

9. Turn the bottle upside down and squeeze it gently to release one drop into each eye
that needs treatment. Do not touch your eye or eyelid with the dropper tip (Fig. 9). If a
drop misses your eye, try again.

The active ingredient is ketorolac trometamol.
Ketorolac eye drops is used to prevent and relieve eye inflammation following surgery on
the eye in adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE KETOROLAC EYE DROPS

Fig. 9

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 nonsteroidal anti-inflammatory drugs (NSAIDs).
• in children or adolescents under the age of 18 years

10. Let go of the lower lid, and close your eye for 30 seconds (Fig. 10).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Ketorolac eye drops if any of the
following apply to you:

Fig. 10

11. Reclose the bottle after use (Fig. 11).

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

Fig. 11

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 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.

You should also consult your healthcare professional first if you are using:
• medicines that thin the blood and reduce blood clotting (anticoagulants such as
warfarin)
• other non-steroidal anti-inflammatory drugs (NSAIDs)


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.

Ketorolac eye drops contain the preservative benzalkonium
chloride which may cause irritation and discolour 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.

Do not use a double dose to make up for a forgotten dose.
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 nurse.

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

4. POSSIBLE SIDE EFFECTS

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 the your vision has cleared.
• Ketorolac eye drops contain benzalkonium chloride as a preservative. If you wear
contact lenses you should remove them prior to application and wait at least 15
minutes before reinsertion.
• The preservative in Ketorolac eye drops benzalkonium chloride, may cause eye
irritation and can permanently damage this type of lens. Ketorolac eye drops is
known to discolour soft contact lenses.
• Avoid contact with soft contact lenses.
3. HOW TO USE KETOROLAC EYE DROPS
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.
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 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.
To avoid contamination, Do not touch or allow the dropper tip touch the eye, areas
around the eye or any surface. It may become contaminated with bacteria that can cause
eye infections leading to serious damage of the eye, even loss of vision.

Like all medicines, Ketorolac eye drops can cause side effects, although not everybody
gets them.
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.
5. HOW TO STORE KETOROLAC EYE DROPS
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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION

Opening the bottle before first use
1. Before using the medication for the first time, check that the tear-off tamper evident
ring is intact and also that the safety ring connection with the cap has not been
broken (Fig.1). You must not use the bottle if the tamper-evident rings on the bottle
neck are broken or removed.
Safety Ring
Tear off tamper
evident ring

2. Before opening the bottle for the first time, tear off the tamper evident ring to break the
seal (Fig.2).

3. To open the bottle, remove the cap by turning it in the counterclockwise direction
(Fig.3).

4.

560 mm

560 mm

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.

After opening the cap remove the safety ring gently (Fig. 4).

What Ketorolac eye drops contains
- The active substance is Ketorolac trometamol.
- The other ingredients are benzalkonium chloride, edetate disodium, 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, 5 ml or 10 ml 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
Middlesex
TW4 5DQ
UK
Distributed by:
Aspire Pharma Ltd
Bellamy House, Winton Road
Petersfield, Hampshire, GU32 3HA,
United Kingdom
This leaflet was last revised in 12/2016.

Fig. 4

5.

Place the cap and tighten the cap on the nozzle completely by turning clockwise. The
spike in the cap will pierce the tip of the bottle. (Fig.5).

Fig. 5

Size: 110 x 560 mm
Front Size

Artwork Code

Size: 110 x 560 mm
Back Size

Pharmacode

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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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