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)

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

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.

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 antiinflammatory 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.

3. HOW TO USE 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.

1.    2.    3.    4.

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, 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 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.

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.

6. FURTHER INFORMATION

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.

|POMl PL No: 08747/0743

Leaflet revision date: 03 August 2012

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

743 LEAFLET Acular 20120803

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.