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ACULAR EYE DROPS 0.5%W/V

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743 LEAFLET Acular 2012803

PACKAGE LEAFLET: INFORMATION FOR USER

ACULAR EYE DROPS 0.5%w/v
KETOROLAC TROMETAMOL EYE DROPS 0.5%w/v
(ketorolac trometamol)

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

Your medicine is known by any of the above name but will be
referred to as Acular throughout the following leaflet.

Acular should not be prescribed for use in children.
Driving and using machines

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.

Acular may cause temporary blurred vision. Do not drive or use
machinery until the symptoms have cleared.



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:

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.

3. HOW TO USE ACULAR

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

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.

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 antiinflammatory drugs (NSAIDs). The active ingredient in Acular is
ketorolac trometamol.

Instructions for use

2. BEFORE YOU USE ACULAR

1. Wash your hands. Tilt your head back and look at the ceiling



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:

2. Gently pull the lower eyelid down until there is a small pocket
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,

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, 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.



viral or bacterial infections of the eye



bleeding tendencies (for example, anaemia) or stomach ulcers



diabetes



rheumatoid arthritis

If you use more Acular than you should



dry eye syndrome



asthma after using non-steroidal anti-inflammatories

The application of too many drops is unlikely to lead to unwanted
side-effects.



or if you have had recent eye surgery.

The proper application of your eye drops is very important. If you
have any questions ask your doctor or pharmacist.

Apply your next dose at the normal time. If, by accident, anyone
drinks this medicine, drink fluids to dilute and contact your doctor.

Using other medicines

If you forget to use Acular

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 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.

If you use Acular with another eye medicine, leave at least 5
minutes between putting in Acular and the other medicine.

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

6. FURTHER INFORMATION

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.
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. 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: stinging and/or burning in the eye, eye pain.
Common side effects (occurring in between 1 and 10 patients in
every 100) are: death of cells on the surface of the eye, allergic
reaction, eye and/or eyelid swelling/ puffiness, irritation of the eye,
itchiness, redness, infection of the eye, inflammation of the eye.
Uncommon side effects (occurring in between 1 and 10 patients
in every 1,000) are: ulcer(s) on the surface of the eye, inflammation
under the surface of the eye, blurred and/or diminished vision,
headache, eye dryness and/or an excess of tears, inflammation of
the iris.

What Acular contains


The solution contains the active ingredient kolorolac Iromelamol
0.5%.



The solution also contains disodium edetate, octoxynol40,
sodium chloride, hydrochloric acid or sodium hydroxide (to
adjust pH), benzalkonium chloride and purified water.

What Acular looks like and contents of the pack
Acular Eye Drops are a clear, sterile solution in a while plastic bottle
with a while plastic applicator cap.
The botlles contain 5ml of solution.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Wembley, HA0
1DX.
Manufacturer
This product is manufactured by Allergan Pharmaceuticals (Ireland)
ltd. Westport. Co. Mayo, Ireland.
POM

PL No: 08747/0743

Leaflet revision date: 03 August 2012
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


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Discard any unused solution 28 days after first opening the
bottle.



Do not break the bottle seal until you are going to use the
drops. They are sterile until the seal is broken. They must be
used within 28 days of first breaking the seal. Do not use the
drops after the date shown on the pack.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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.

Acular is a registered trade mark of by Allergan, Inc.
743 LEAFLET Acular 20120803

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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