iMedi.co.uk

Acular

Informations for option: Acular, show other option
Document: leaflet MAH BRAND_PL 00426-0082 change

Insert - ACULAR® - Great Britain - MOH Submission


r


_o _


*@ALLERCAIM

PACKAGE LEAFLET: Information for the user



i



ACULAR®

0.5% (w/v) Eye Drops, 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.

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

•    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.


Artwork created at 100%

Drop all keylines and notes before printing Part Number: 72086MD240F Drawing Number: 0106901


INSERT, TYPE B 3/4, PENCIL EELD,

228nm x 265mn EELDED TE 114nn x 23nn 0106901



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.



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 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.

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

Website: 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 this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the bottle label and the bottom of the carton after EXP 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.

Store below 25°C.

Do not use this medicine if you notice the tamper-proof seal is broken.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information What ACULAR contains

•    The active substance is Ketorolac trometamol 0.5% w/v.

•    The other ingredients are benzalkonium chloride, disodium edetate, octoxinol 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 3 ml, 5 ml or 10 ml of the eye drops as written on the front of the pack. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Allergan Limited,

Marlow International,

The Parkway,

Marlow,

Bucks, SL7 1YL

Tel: 01628 494026 Fax: 01628 494057

uk_medinfo@allergan.com.............

Manufacturer

Allergan Pharmaceuticals Ireland,

Westport,

Co. Mayo,

Ireland

This leaflet was last revised in 09/2014

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only).

Please be ready to give the following information: Ketorolac 0.5% reference number PL 00426/0082.

This is a service provided by the Royal National Institute of Blind People.


72086MD240F


ALLERG AIM

© 2014 Allergan, Inc., Irvine CA 92612 ® Marks owned by Allergan, Inc.