Acular 0.5% w/v Eye Drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ketorolac trometamol

Available from:

Allergan Pharmaceuticals Ireland

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:

Marketed

Authorization date:

1995-06-14

Patient Information leaflet

1
B. PACKAGE LEAFLET
2 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 prescr

Summary of Product characteristics

Health Products Regulatory Authority
11 June 2019
CRN008JSD
Page 1 of 6
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 0.1 mg/ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
Clear, colourless to pale yellow aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the prophylaxis and reduction of inflammation following cataract
surgery.
Acular is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
_Post-operative inflammation:_
One drop instilled into the eye three times daily starting 24 hours
before surgery and continuing for three to four weeks.
_Paediatric population_
There is no relevant use of ACULAR in the paediatric population in the
indication: For the prophylaxis and reduction of
inflammation following cataract surgery.
_Elderly Population_
No overall differences in safety or effectiveness have been observed
between elderly and younger patients.
_Method of administration_
Ocular use.
Instil one drop of the solution into the inferior conjunctival sac of
the eye to be treated, while pulling the lower eyelid gently
downwards and looking upwards.
If ACULAR is used concomitantly with other topical eye medications
there must be an interval of at least 5 minutes between the
two medications.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1.
The potential exists for cross-sensitivity to acetylsalicylic acid and
other non-steroidal anti-inflammatory drugs. ACULAR is
contra-indicated in individuals who have previously exhibited
sensitivities to these drugs.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Health Products Regulatory Authority
11 June 2019
CRN008JSD
Page 2 of 6
It is recommended that ACULAR is used with caution in patients with
known bleeding tendencies or who are receiving oth