Ketorolac 0.5% eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ketorolac trometamol

Available from:

Dowelhurst Ltd

ATC code:

S01BC05

INN (International Name):

Ketorolac trometamol

Dosage:

5mg/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11080200

Patient Information leaflet

110 mm
110 mm
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
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.
-
If you have any further questions, ask your doctor,or pharmacist or
nurse.
-
Keep this leaflet. You may need to read it again.
WHAT IS IN THIS LEAFLET
The active ingredient is ketorolac trometamol.
•
If you are allergic to aspirin (acetylsalicylic
acid) or other non-steroidal
anti
inflammatory drugs (NSAIDs).
•
If you are ALLERGIC to ketorolac trometamol, or any of the other
ingredients of this
medicine (listed in section 6).
4.
Possible side effects
6.
Contents of the pack and other information
Ketorolac eye drops belongs to a group of medicines known as
non-steroidal anti-
inflammatory drugs (NSAIDs).
Talk to your doctor, pharmacist or nurse before using Ketorolac eye
drops
If you suffer from, or have in the past suffered from:
•
corneal damage
1.
What Ketorolac eye drops is and what it is used for
•
vision or sight disturbances 2.
WHAT YOU NEED TO KNOW BEFORE YOU USE KETOROLAC EYE DROPS
•
viral or bacterial infections of the eye 1.
WHAT KETOROLAC EYE DROPS IS AND WHAT IT IS USED FOR
Ketorolac eye drops is used to prevent and relieve eye inflammation
following surgery on
the eye in adults.
WARNINGS AND PRECAUTIONS
•
bleeding tendencies (for example, anaemia)
DO NOT USE KETOROLAC EYE DROPS
•
stomach ulcer
2.
What you need to know before you use Ketorolac eye drops
5.
How to store Ketorolac eye drops
3.
How to use Ketorolac eye drops
Ketorolac eye drops may cause temporary blurred vision. Do not drive
or use machinery
until the your vision has cleared.
You must not use the bottle if the tamper-proof seal on the bottle
neck is broken before you
first use it.
Y

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ketorolac trometamol 0.5% w/v eye drops, solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 5 mg of ketorolac trometamol (0.5 % w/v)
Excipients(s): contains benzalkonium chloride 0.1 mg/ml (0.01 %w/v)
For a the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Eye Drops, Solution.
Clear, colourless to pale yellow solution practically free from
particles.
4.1
THERAPEUTIC INDICATIONS
Ketorolac trometamol 0.5% w/v eye drops, solution are indicated for
the prophylaxis
and reduction of
inflammation and associated symptoms following ocular surgery.
Ketorolac trometamol 0.5% w/v eye drops, 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
pre-operatively and
continuing for up to three weeks post-operatively.
_Paediatric population _
_ _
There is no relevant use of Ketorolac trometamol 0.5% w/v eye drops,
solution 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.
If 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 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. Ketorolac trometamol 0.5% w/v eye drops,
solution are
contra-indicated in individuals who have previously exhibited
hypersensitivity to
these drugs.
4.
CLINICAL PARTICULARS
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
It is recommended that Ketorolac trometamol 0.5% w/v eye drops,
solution be used
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