ACULAR Eye Drops Solution 0.5 %w/v
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
11-05-2024
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Active ingredient:
KETOROLAC TROMETAMOL
Available from:
LTT Pharma Limited
Dosage:
0.5 %w/v
Pharmaceutical form:
Eye Drops Solution
Authorization date:
2010-11-12
Summary of Product characteristics
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 0.5% w/v
Excipients: Benzalkonium chloride 0.01% w/v
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Eye drops, solution
Product imported from the UK
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.
_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.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or any of the excipients
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.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 09/12/2011_
_CRN 2099810_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
It is recommended that ACULAR
®
be used with caution in patients with known bleeding tendencies or who
arereceiving other medications which may prolong ble
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