Acular 0.5% EyedropsOut of date information, search another
PATIENT INFORMATION LEAFLET
Your medicine is available using the names Acular 0.5% Eye Drops or Ketorolac Trometamol 0.5% Eye Drops, but will be referred to as Acular throughout this leaflet.
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.
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 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
• 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.
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.
L of 2
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
Yellow Card Scheme
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ACULAR
• Keep the medicine in a safe place out of the sight and reach of children.
• Store the medicine at room temperature.
• The product should not be used after the expiry date (this is printed on both the label on the bottle and on the bottom of the carton that the bottle is packed in). The expiry date refers to the last day of the month.
• Throw the bottle away 15 days after opening, even if there is solution remaining.
• If your medicine appears to be discoloured or shows any other signs of deterioration, please return to your pharmacist who will advise you further.
• If your doctor tells you to stop taking the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Acular contains
Its active ingredient is: ketorolac trometamol 0.5% w/v. It also contains: sodium chloride, benzalkonium chloride, edetate disodium, octoxynol 40, sodium hydroxide and hydrochloric acid (to adjust pH) and purified water.
What Acular looks like and contents of the pack
Acular is a clear, colourless, sterile solution contained in a plastic dropper bottle.
Each bottle contains 5ml of the medicine.
Your medicine is manufactured by: Allergan Pharmaceuticals Ireland, Westport, Co. Mayo, Ireland.
Procured within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Leaflet revision and issue date (Ref): 09.12.14
To request a copy of this leaflet in Braille, large print or audio please call 01302 365000 and ask for the regulatory Department.
Please be ready to give the following information:
Product Name: Acular 0.5% Eye Drops/Ketorolac Trometamol 0.5% Eye Drops
Reference number: 04423/0415
ACULAR® is a registered trademark of Allergan Inc.