Acular

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.
• 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:

• 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

Do not use Acular

• If you are allergic (hypersensitive) to:
  
  
  • ketorolac trometamol,
  • benzalkonium chloride,
  • aspirin or other similar drugs,
  • other ingredients listed in section 6

• In children under the age of 18
• If you are pregnant or breast-feeding

Take special care with ACULAR

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
• A tendency to bleed
• Stomach ulcers
• Diabetes
• Rheumatoid arthritis
• Dry eye syndrome
• Or if you have had other 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.

Tell you doctor before using ACULAR, if you are:

• currently taking medicine that increases the time needed for your blood to clot
• currently using any steroid on the eye and are prone to eye ulcers, since this may cause damage to the surface of the eye or slow down healing

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

Do not use ACULAR if you are pregnant or breast-feeding.

Ask your doctor or pharmacist for advice before using any medicine.

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

Contact lenses

• Do not use the drops while your contact lenses are in your eyes. Wait at least 15 minutes after using the eye drops before putting your lenses back in your eyes
• A preservative in ACULAR (benzalkonium chloride) may cause eye irritation and is also known to discolour soft contact lenses

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

Putting too many drops in your eye(s) is unlikely to lead to unwanted side-effects. If you have placed too many drops in your eye(s), wash your eye(s) with clean water. Apply your next dose at the normal time. If, by accident, anyone drinks this medicine, contact your doctor straight away.

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 use 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.

You should see your doctor immediately if you experience the following side effects:

• pain in your eye(s)
• increased irritation in your eye(s)
• changes in your vision

Very common side effects (occurring in more than 1 in 10 patients) are:

• irritation and/or burning in the eye

Common side effects (occurring in between 1 and 10 patients in every 100 patients) are:

• Small grey bumps on the surface of the eye, with or without inflammation
• eye pain or stinging
• allergic reaction
• eye and/or eyelid swelling/puffiness
• itchiness and/or redness of the eye

Rare side effects (occurring in between 1 and 10 patients in every 10,000 patients) are:

• ulcer(s) on the surface of the eye
• areas of inflammation under the surface of the eye
• blurred or reduced vision
• headache
• eye dryness
• an excess of tears

What ACULAR contains

• The active substance is Ketorolac trometamol 0.5% w/v
• The other ingredients are benzalkonium chloride, edetate disodium, 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 in a plastic bottle.

Each pack contains 1 plastic bottle with a screw cap. Each bottle is about half full and contains 3ml, 5 ml or 10ml of the eye drops as written on the front of the pack. Not all pack sizes may be marketed.

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