Acular

Main information

  • Trade name:
  • Acular 0.5% w/v Eye drops, solution
  • Dosage:
  • 0.5% w/v
  • Pharmaceutical form:
  • Eye drops, solution
  • Units in package:
  • Bottle, dropper, 3mL, 3 mL
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Recordati SpA

Documents

Localization

  • Available in:
  • Acular 0.5% w/v Eye drops, solution
    New Zealand
  • Language:
  • English

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 2905
  • Authorization date:
  • 20-06-1996
  • Last update:
  • 27-09-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

ACULAR

(Ketorolac Trometamol) Eye Drops-CMI Version 3.0

Page 1 of 3

ACULAR

®

EYE DROPS

5 mg/mL Eye Drops (ketorolac trometamol)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about ACULAR

drops, including how to use the eye

drops. It does not contain all the

available information. It does not

take the place of talking to your

doctor or pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using ACULAR

eye drops against the benefits they

expect it will have for you.

If you have any concerns about

using this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the

medicine. You may need to read it

again.

What ACULAR

®

eye drops are

used for

These eyedrops contain the drug

ketorolac trometamol and are used

to treat itchy eyes occurring in the

condition called seasonal allergic

conjunctivitis. They are also used

for the relief of swelling and

redness after cataract surgery.

Ketorolac trometamol works by

decreasing prostaglandin E

levels

in the eye. Prostaglandins are

normally produced by the body and

are thought to be associated with

pain, itching and inflammation.

ACULAR

eye drops are only

available with a doctor’s

prescription from pharmacies.

Your doctor may have

prescribed ACULAR

drops for another reason.

Ask your doctor if you have

any questions about why

ACULAR

eye drops have

been prescribed for you.

Before you use ACULAR

®

eye

drops

When you must not use it

Do not use ACULAR

eye drops if:

You have an allergy to ketorolac

trometamol or to any of the

ingredients listed at the end of

this leaflet.

You have ever had an allergic

reaction to aspirin or certain

types of medicines used for

arthritis or pain relief (non

steroidal anti-inflammatory

drugs).

The seal around the cap is

broken.

The bottle/packaging shows

signs of tampering.

The product does not look quite

right.

The expiry date on the bottle

has passed.

If you use this medicine after the

expiry date has passed, it may not

work effectively.

Do not put the eye drops into your

eye(s) while you are wearing soft

contact lenses. The preservative in

ACULAR

eye drops.

(benzalkonium chloride) may be

deposited in soft contact lenses.

You can put your soft contact

lenses back into your eyes 15

minutes after you have used

ACULAR

eye drops.

It is not known if ACULAR

drops are safe and useful for

children under 12 years.

These drops are for topical use

only.

Before you start to use it

Tell your doctor if:

You have had an allergy to any

medicines or any other

substances, such as foods,

preservatives or dyes

You are taking any other

prescription or nonprescription

medicine, particularly those

which have an effect on

bleeding

You have a peptic ulcer or a

history of peptic ulcers

You have asthma or a history

of asthma

You have defects of the

cornea, sugar

diabetes,diseases of the eye

(e.g. dry eye syndrome),

rheumatoid arthritis, or if you

have had recent eye surgery

You are pregnant, or intend to

become pregnant. ACULAR

eye drops are not

recommended in pregnancy

You are breastfeeding or intend

to breastfeed

ACULAR

eye drops are not

recommended if you are

breastfeeding

You have a condition that

causes you to bleed easily.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy without a prescription

from your pharmacy, supermarket

or health food shop.

It is not expected that ACULAR

will interact with other medicines,

however you should always ask

your optical practitioner, doctor or

pharmacist if you have any

concerns about using ACULAR

eye drops as well as other

medications.

How to use ACULAR

®

eye drops

How much to use

Your doctor will tell you how many

drops you need to use each day.

Use ACULAR

eye drops only as

prescribed by your doctor.

The usual dose for itchy eyes

(seasonal allergic conjunctivitis) is

one drop into each eye four times

daily for 2-4 weeks.

The usual dose for use before and

after eye surgery for cataract

removal is one or two drops into

each eye four times daily, starting

24 hours before the surgery and

continuing for 2-4 weeks.

Follow all directions given to you by

your doctor carefully. The directions

may differ from the information

ACULAR

(Ketorolac Trometamol) Eye Drops-CMI Version 3.0

Page 2 of 3

contained in this leaflet.

If you are using more than one eye

drop product, wait 5 minutes before

using the second product.

If you are being changed from one

eye drop to another, follow your

doctor’s instructions carefully as to

when to stop the old drops and

when to start the new drops.

How to use it

You may find it easier to put drops

in your eye while you are sitting or

lying down.

If you are wearing soft contact

lenses, remove them before

putting the drops in your eye.

To open a new bottle of ACULAR

eye drops first tear off the

protective seal from the bottle. The

contents are sterile if the seal is

intact. The seal will break and you

can pull it off and then throw it

away.

1. Wash your hands well with soap

and water

2. Remove the lid/cap

3. Hold the bottle upside down in

one hand between your thumb

and forefinger or index finger

4. Using your other hand, gently

pull down your lower eyelid to

form a pouch or pocket

5. Tilt your head back and look up.

6. Put the tip of the bottle close to

your lower eyelid. Do not let it

touch your eye

7. Release one drop into the pouch

or pocket formed between your

eye and eyelid by gently

squeezing the bottle

8. Close your eye. Do not blink or

rub your eye

9. While your eye is closed, place

your index finger against the

inside corner of your eye and

press against your nose for

about two minutes. This will

help to stop the medicine from

draining through the tear duct to

the nose and throat, from where

it can be absorbed into other

parts of your body. Ask your

doctor for more specific

instructions on this technique.

10. Replace the lid/cap, sealing it

tightly

11. Wash your hands again

with soap and water to remove any

residue.

Wait 15 minutes before replacing

your contact lenses.

Be careful not to touch the dropper

tip against your eye, eyelid or

anything else to avoid

contaminating the eye drops.

How long to use it

Continue using ACULAR

drops for as long as your doctor

prescribes.

The usual length of use is 2-4

weeks.

If you forget to use it

If it is almost time for your next

dose, skip the dose you missed

and use your next dose when you

are meant to. Otherwise, use the

drops as soon as you remember,

and then go back to using them as

you would normally.

If you are not sure whether to skip

the dose, talk to your doctor or

pharmacist.

Do not use double the amount to

make up for the dose that you

missed.

If you use too much

(overdose)

If you accidentally put several

drops in your eye(s), immediately

rinse your eye(s) with warm water.

If you think that you or anyone else

may have swallowed any or all of

the contents of a bottle of

ACULAR

eye drops drink fluids to

dilute and immediately telephone

your doctor or Poisons

Information Centre

(Australia: telephone 13 11 26;

New Zealand: telephone 0800

POISON or 0800 764 766) for

advice, or go to casualty at your

nearest hospital. Do this even if

there are no signs of discomfort or

poisoning.

While you are using ACULAR

®

eye drops

Things you must do

If you develop an eye infection,

receive an eye injury, or have eye

surgery tell your doctor.

Your doctor may tell you to use a

new container of ACULAR

drops because of possible

contamination of the old one or

may advise you to stop your

treatment with ACULAR

drops.

If you become pregnant while using

ACULAR

eye drops tell your

doctor immediately.

If you wear soft contact lenses,

remove them before using

ACULAR

eye drops. Leave your

lenses out for at least 15 minutes

after putting in the eye drops.

Tell your doctor if your condition

gets worse or does not get better

while using ACULAR

eye drops.

If you are about to start any new

medicine tell your doctor and

pharmacist that you are using

ACULAR

eye drops.

Things you must not do

Do not give ACULAR

eye drops to

anyone else, even if they have the

same condition as you.

Do not stop using ACULAR

drops without first talking to your

doctor.

Things to be careful of

Your vision may blur for a short

time after you put in your ACULAR

eye drops. If this happens you

should wait until you can see well

again before you drive or use

machinery.

ACULAR

eye drops are not

expected to cause any problems

with your ability to drive a car or

operate machinery. However, as a

general precaution be careful

driving or operating machinery until

you know how ACULAR

eye drops

affect you.

Side effects

Tell your optical practitioner, doctor

or pharmacist as soon as possible

if you do not feel well while you are

ACULAR

(Ketorolac Trometamol) Eye Drops-CMI Version 3.0

Page 3 of 3

using ACULAR

eye drops.

Check with your doctor as soon as

possible if you have any problems

while taking ACULAR

eye drops,

even if you do not think the

problems are connected with the

medicine or are not listed in this

leaflet.

All medicines can have side effects.

Sometimes they are serious, most

of the time they are not. You may

need medical treatment if you get

some of the side effects.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them. Ask your

doctor or pharmacist to answer any

questions you may have.

Some side effects of ACULAR

eye drops are:

burning and stinging of the eye

on instillation

blurring of vision

infection of the eye or

surrounding areas

inflammation of the front layer

of the eyeball or the coloured

part of the eye

conjunctivitis (scratching,

foreign body sensation, itching,

redness)

local allergic reactions, such as

red eye, stinging of the eye

irritation of the surface of the

eye or feeling of having

something in the eye

drooping of the upper eyelid

swollen eyelid

uncomfortable sensitivity to

light

eye dryness

a lesion on the front layer of the

eyeball

increased pressure in the eye

white spots on the surface of

the eye

headaches.

visual disturbance

hypersensitivity

After using ACULAR

®

eye drops

Storage

Keep your eye drops in a cool

place where the temperature stays

below 25

C, and out of the light.

Do not store it or any other

medicine in the bathroom or near a

sink. Do not leave it in the car or on

window sills. Do not carry the eye

drops in pockets of your clothes.

Heat and dampness can destroy

some medicines.

Keep it where children cannot

reach it. A locked cupboard at

least one-and-a-half metres above

the ground is a good place to store

medicines.

Do not leave the top/lid off the

bottle for any length of time to avoid

contaminating the eye drops.

Disposal

Write the date on the bottle when

you open the eye drop and throw

out any remaining solution after

four weeks from the date of

opening.

Eye drops contain a preservative

which helps prevent germs growing

in the solution for the first four

weeks after opening the bottle.

After this time there is a greater risk

that the drops may become

contaminated and cause an eye

infection. A new bottle should be

opened.

If your doctor tells you to stop using

the eye drops or they have passed

their expiry date, ask your

pharmacist what to do with any

remaining solution.

Product description

What ACULAR

®

eye drops look

like:

Clear, colourless to pale yellow,

sterile solution, supplied in a white

opaque plastic bottle with a dropper

tip.

Ingredients

Active ingredient:

Ketorolac trometamol 5.0mg/mL

Preservative:

Benzalkonium chloride

Inactive ingredients:

sodium chloride, edetate disodium

octoxinol 40

purified water

sodium hydroxide and/or

hydrochloric acid may be added to

adjust pH

Manufacturer/Supplier

Allergan Australia Pty Ltd

810 Pacific Highway,

Gordon NSW 2072

ABN 85 000 612 831

Toll free: 1800 252 224 (Australia)

Allergan New Zealand Limited

Corner of Manu Tapu Drive and

Joseph Hammond Place

Auckland International Airport

Mangere

AUCKLAND

Freephone: 0800 659 912 (NZ)

ACULAR

eye drops can be

identified by registration number:

AUST R 63539

ACULAR

is owned by Syntex Pharma

AG and licenced to Allergan, Inc.

Date of preparation:

December 2011

©2011 Allergan, Inc.

There are no safety alerts related to this product.

14-12-2018


Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Europe - EMA - European Medicines Agency