Acular
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
26-05-2023
Summary of Product characteristics
(SPC)
26-05-2023
Active ingredient:
Ketorolac trometamol 5 mg/mL; ;
Available from:
AbbVie Limited
INN (International Name):
Ketorolac trometamol 5 mg/mL
Dosage:
0.5% w/v
Pharmaceutical form:
Eye drops, solution
Composition:
Active: Ketorolac trometamol 5 mg/mL Excipient: Benzalkonium chloride Disodium edetate dihydrate Hydrochloric acid Macrogols Purified water Sodium chloride Sodium hydroxide
Units in package:
Bottle, dropper, 3mL, 3 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Recordati SpA
Product summary:
Package - Contents - Shelf Life: Bottle, dropper, - 3 mL - 24 months from date of manufacture stored at or below 25°C - Bottle, dropper, - 5 mL - 24 months from date of manufacture stored at or below 25°C - Bottle, dropper, - 10 mL - 24 months from date of manufacture stored at or below 25°C
Authorization date:
1996-06-20
Patient Information leaflet
ACULAR
®
CMI v6-PI-v5
Page 1 of 3
ACULAR
® EYE DROPS
(KETOROLAC TROMETAMOL) 5 MG/ML EYE DROPS
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ACULAR
®
eye
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
2
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.
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
Read the complete document
Summary of Product characteristics
NEW ZEALAND DATA SHEET
ACULAR
®
(ketorolac trometamol 5 mg/mL) Data Sheet V5.0 CCDS 4 25 April 2023
Page
1
of
7
1
PRODUCT NAME
ACULAR
®
(Ketorolac trometamol) 5 mg/mL Eye Drops
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACULAR
contains ketorolac trometamol (5 mg/mL) as the active ingredient.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Ketorolac trometamol is a white to off-white crystalline substance,
which is a racemic
mixture. It may exist in three crystalline forms, all of which are
equally soluble in water.
Ketorolac trometamol 5mg/mL ophthalmic solution is a clear, colourless
to pale yellow,
sterile, isotonic aqueous solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ACULAR
®
eye drops are indicated for the short term (2 - 4 weeks) prophylaxis
and reduction
in inflammation in patients undergoing cataract extraction.
ACULAR
®
eye drops are also indicated for the short term (2 - 4 weeks) relief
of symptoms of
seasonal allergic conjunctivitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
SEASONAL ALLERGIC CONJUNCTIVITIS
The recommended dose of ACULAR
®
eye drops for allergic conjunctivitis is one drop (0.25
mg) instilled in the eye four times daily. Treatment may be continued
for up to four weeks.
POST-OPERATIVE INFLAMMATION
The recommended dose of ACULAR
®
eye drops for the prophylaxis and treatment of post
operative inflammation in patients who have undergone cataract
extraction is 1 - 2 drops
(0.25 to 0.5 mg) four times daily, starting 24 hours before surgery
and continuing for 2 - 4
weeks.
4.3
CONTRAINDICATIONS
ACULAR
®
eye drops are contraindicated in patients hypersensitive to any of the
components
of the medication.
The potential exists for cross sensitivity to acetylsalicylic acid,
phenylacetic acid derivatives,
and other nonsteroidal anti-inflammatory medicines. ACULAR
®
is contraindicated in
patients who have previously exhibited sensitivities to these drugs.
ACULAR
®
eye drops are contraindicated in children.
NEW ZEALAND DATA SHEET
ACULAR
Read the complete document
