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ACULAR 0.5% W/V OPHTHALMIC SOLUTION

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Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at:www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this
medicine.
5. How to store Acular
Keep out of the sight and reach of children
Do not use the product if the tamper proof seal on the bottle is broken.
Do not use the product after the expiry date. (This is printed on both the label on the
bottle and on the bottom of the carton). 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.
If your doctor tells you to stop using this medication, take any unused solution back
to your pharmacist for safe disposal. Only keep it if your doctor tells you to.
If the solution becomes discoloured or shows any signs of deterioration, seek the
advice of your pharmacist.
6. Contents of the pack and other information
What Acular contains
Each ml of eye drops solution contains 0.5% of ketorolac trometamol as the
active ingredient.
It also contains: benzalkonium chloride, disodium edetate, octoxynol 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 and is contained in a bottle
with a dropper applicator.
Each bottle contains 5ml of the medicine.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Acular® 0.5% w/v Ophthalmic 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.
The name of your medicine is Acular 0.5% w/v Ophthalmic Solution but will be
referred to as Acular throughout this leaflet.
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

Manufactured by: Allergan SA., Av. De la Industria 24, Tres Cantos, 1300-278,
Madrid, Spain.
Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
®

Acular 0.5% w/v Ophthalmic Solution PL No: 18799/1713
Leaflet date: 06.11.2014
Acular is a registered trademark of Allergan, Inc.

POM

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.
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.
Acular contains benzalkonium chloride
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.
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.
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.

PACKAGE LEAFLET: INFORMATION FOR THE USER
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at:www.mhra.gov.uk/yellowcard. By reporting
side effects, you can help provide more information on the safety of this medicine
5. How to store Ketorolac
Keep out of the sight and reach of children
Do not use the product if the tamper proof seal on the bottle is broken.
Do not use the product after the expiry date. (This is printed on both the label on the
bottle and on the bottom of the carton). 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.
If your doctor tells you to stop using this medication, take any unused solution back
to your pharmacist for safe disposal. Only keep it if your doctor tells you to.
If the solution becomes discoloured or shows any signs of deterioration, seek the
advice of your pharmacist.
6. Contents of the pack and other information
What Ketorolac contains
Each ml of eye drops solution contains 0.5% of ketorolac trometamol as the
active ingredient.
It also contains: benzalkonium chloride, disodium edetate, octoxynol 40, sodium
chloride, sodium hydroxide or hydrochloric acid (to adjust pH) and purified water.
What Ketorolac looks like and contents of the pack
Ketorolac is a clear, colourless to slightly yellow solution and is contained in a bottle
with a dropper applicator.
Each bottle contains 5ml of the medicine.
Manufactured by: Allergan SA., Av. De la Industria 24, Tres Cantos, 1300-278,
Madrid, Spain.
Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Ketorolac 0.5% w/v Ophthalmic Solution PL No: 18799/1713
Leaflet date: 06.11.2014

POM

Ketorolac Trometamol 0.5% w/v Ophthalmic
Solution
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.
The name of your medicine is Ketorolac Trometamol 0.5% w/v Ophthalmic Solution
but will be referred to as Ketorolac throughout this leaflet.
What is in this leaflet:
1. What Ketorolac is and what it is used for
2. What you need to know before you use Ketorolac
3. How to use Ketorolac
4. Possible side effects
5. How to store Ketorolac
6. Contents of the pack and other information
1. What Ketorolac is and what it is used for
Ketorolac is used to prevent and relieve eye inflammation following surgery on the
eye in adults.
Ketorolac belongs to a group of medicines known as non-steroidal anti-inflammatory
drugs (NSAIDs). The active ingredient in Ketorolac is ketorolac trometamol.
2. What you need to know before you use Ketorolac
Do not use Ketorolac
If you are allergic (hypersensitive) 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 Ketorolac.
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 Ketorolac
Please 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 Ketorolac with another eye medicine, leave at least 5 minutes between
putting in Ketorolac and the other medicine.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before using this medicine.
Ketorolac should not be used if you are pregnant or might become pregnant
or are breast-feeding, unless your doctor recommends it.
Children
Ketorolac should not be prescribed for use in children.
Driving and using machines
Ketorolac may cause temporary blurred vision. Do not drive or use machinery until
the symptoms have cleared.
Important information about some of the ingredients of Ketorolac
If you wear contact lenses you should remove them prior to application and wait
at least 15 minutes before reinsertion.
The preservative in Ketorolac benzalkonium chloride, may cause eye irritation
and can permanently damage this type of lens. Ketorolac is known to discolour
soft contact lenses.
Avoid contact with soft contact lenses.
3. How to use Ketorolac
Always use this medicine exactly as your doctor has told you. You should 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 Ketorolac 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 Ketorolac
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 Ketorolac
Ketorolac 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
Ketorolac 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.
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.

Expand Transcript

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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