ACULAR 0.5% w/v Eye drops, solution

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Ketorolac trometamol

Διαθέσιμο από:

PCO Manufacturing Ltd.

Φαρμακολογική κατηγορία (ATC):

S01BC; S01BC05

INN (Διεθνής Όνομα):

Ketorolac trometamol

Δοσολογία:

0.5 percent weight/volume

Φαρμακοτεχνική μορφή:

Eye drops, solution

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

Antiinflammatory agents, non-steroids; ketorolac

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2012-07-20

Φύλλο οδηγιών χρήσης

_ _
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
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 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
6).

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

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
07 June 2022
CRN00CZ0D
Page 1 of 2
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.
Excipient(s) with known effect: 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 PA1824/015/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1824/015/001
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.
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
Health Products Regulatory Authority
07 June 2022
CRN00CZ0D
Page 2 of 2
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 Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
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
June 2022