ACULAR 0.5% w/v Eye drops, solution

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Ketorolac trometamol
Available from:
PCO Manufacturing Ltd.
ATC code:
S01BC; S01BC05
INN (International Name):
Ketorolac trometamol
Dosage:
0.5 percent weight/volume
Pharmaceutical form:
Eye drops, solution
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Antiinflammatory agents, non-steroids; ketorolac
Authorization status:
Authorised
Authorization number:
PPA0465/287/001
Authorization date:
2012-07-20

Package leaflet: Information for the user

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 or nurse.

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 or nurse. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What ACULAR is and what it is used for

What you need to know before you use ACULAR

How to use ACULAR

Possible side effects

How to store ACULAR

Contents of the pack and other information

1.

What Acular is and what it is used for

Acular is used to prevent and reduce eye inflammation

following cataract surgery in adults. Acular belongs to a

group of medicines known as non-steroidal anti-

inflammatory drugs (NSAIDS).

2.

What you need to know before you use Acular

Do not use ACULAR

If you are allergic to ketorolac trometamol or any of

the other ingredients of this medicine (listed in section

If you are allergic to aspirin or any other similar drugs,

such as other non-steroidal anti-inflammatory drugs.

Warnings and precautions

Talk to your doctor or pharmacist or nurse 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

if you have had recent eye surgery

if you have lost sensitivity in the cornea (the clear

surface covering the pupil and iris) or if the normally

smooth surface of the cornea is damaged.

Children

ACULAR should not be prescribed for use in children.

Other medicines and ACULAR

Tell your doctor or pharmacist if you are using or have

recently used or might use any other medicines. 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

If you are pregnant or breast-feeding, think you may be

pregnant or are planning to have a baby, ask your doctor

or pharmacist for advice before taking this medicine.

ACULAR should not be used if you are pregnant or

breast-feeding, unless your doctor recommends it.

Driving and using machines

ACULAR may cause blurred vision in some patients. Do

not drive or use machinery until the symptoms have

cleared.

ACULAR contains Benzalkonium chloride

Benzalkonium chloride may be absorbed by soft contact

lenses and may change the colour of the contact lenses.

You should remove contact lenses before using this

medicine and put them back 15 minutes afterwards.

Benzalkonium chloride may also cause eye irritation,

especially if you have dry eyes or disorders of the cornea

(the clear layer at the front of the eye). If you feel

abnormal eye sensation, stinging or pain in the eye after

using this medicine, talk to your doctor.

3.

How to use ACULAR

Always use ACULAR exactly as your doctor or

pharmacist has told you. Check with your doctor or

pharmacist if you are not sure. The recommended dose is

1 drop in the affected eye 3 times a day for 3-4 weeks

following cataract surgery, starting 24 hours before

surgery.

Instructions for use

Apply your eye drops in the following way:

Wash your hands. Tilt your head back and look at the

ceiling.

Gently pull the lower eyelid down until there is a small

pocket.

Turn the bottle upside down and squeeze it to release

one drop into each eye that needs treatment.

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

If you have any further questions on the use of this

product, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects,

although not everybody gets them.

Very common: may affect more than 1 in 10 people

Irritation of the eye, stinging and/or burning in the eye,

eye pain.

Common: may affect up to 1 in 10 people

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: may affect up to 1 in 100 people

Inflammation or damage to the front clear layer of the eye,

eye dryness and/or watery eyes.

Not known: frequency cannot be estimated from the

available data

Damage on the surface of the eye such as thinning,

erosion, perforation, degradation of cell(s), difficulty in

breathing or wheezing, aggravation of asthma, swollen

face, ulcer-damage to the surface of the eye.

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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist

or nurse. This includes any possible side effects not listed

in this leaflet. You can also report side effects directly via

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

E-mail: medsafety@hpra.ie

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 15 days after opening, even if

there is solution remaining.

Store below 25°C.

Do not use ACULAR 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 to 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 sodium chloride,

benzalkonium chloride 50% solution, sodium edetate,

octoxinol, 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 eye drop

solution in a plastic bottle.

Each carton contains 1 plastic bottle with a screw cap.

Each bottle contains 5ml of the eye drop solution.

Product procured from within the EU, repackaged and

distributed by the Parallel Product Authorisation

holder:

PCO Manufacturing Ltd., Unit 10, Ashbourne Business

Park, Rath, Ashbourne, Co. Meath, Ireland.

Manufacturer

Allergan Pharmaceuticals Ireland, Westport, Co. Mayo,

Ireland

This medicinal product is authorised in the Member

States of the EEA under the following names:

Austria

ACULAR 0,5% Augentropfen

Belgium,

ACULARE oogdruppels

Denmark, Ireland,

Italy, United

Kingdom

ACULAR

Finland

ACULAR 5 mg/ml eye drops

France

ACULAR 0,5%

Germany

ACULAR 5 mg/ml Augentropfen

Greece

ACULAR 0.5%

Luxembourg

ACULARE collyre

Netherlands

ACULAR oogdruppels 0,5%

Portugal

ACULAR 0,5% p/v colírio solução

Spain

ACULAR 0,5% p/v colirio en solución

This leaflet was last revised in 10/2019.

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

ACULAR 0.5% w/v Eye drops, solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Ketorolac trometamol 5 mg/ml.

Excipients: Benzalkonium chloride

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Eye drops, solution

Product imported from France

Clear, colourless to pale yellow aqueous solution.

4 CLINICAL PARTICULARS

As per PA0148/057/001

5 PHARMACOLOGICAL PROPERTIES

As per PA0148/057/001

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium chloride

Benzalkonium chloride 50% solution

Sodium Edetate

Octoxinol

Sodium hydroxide 1N or hydrochloric acid 1N

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

The shelf-life expiry date of this product shall be the date shown on the container and outer package of the product on

the market in the country of origin.

Use within 15 days of first opening.

6.4 Special precautions for storage

Store below 25°C.

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6.5 Nature and contents of container

5ml of solution in a dropper bottle (PE) with a screw cap

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from

such medicinal product and other handling of the product

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.

7 PARALLEL PRODUCT AUTHORISATION HOLDER

PCO Manufacturing

Unit 10, Ashbourne Business Park

Rath

Ashbourne

Co. Meath

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA0465/287/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 20th July 2012

10 DATE OF REVISION OF THE TEXT

May 2015

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