Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Ketorolac trometamol 0.5% w/v eye drops, solution
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Ketorolac trometamol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Ketorolac eye drops belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). The active ingredient is ketorolac trometamol. Ketorolac eye drops is used to prevent and relieve eye inflammation following surgery on the eye in adults.
2.
What you need to know before you take it
e Ketorolac eye drops
Do not use Ketorolac eye drops
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 (acetylsalicylic acid) or other non-steroidal anti-inflammatory drugs (NSAIDs).
Warnings and precautions 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 vision or sight disturbances viral or bacterial infections of the eye
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BROWN & BURK UK LTD MODULE 1 ADMINISTRATIVE AND PRESCRIBING INFORMATION MODULE 1.3 PRODUCT INFORMATION KETOROLAC TROMETAMOL 0.5%w/v EYE DROPS, SOLUTION
bleeding tendencies (for example, anaemia) stomach ulcer diabetes rheumatoid arthritis dry eye syndrome asthma after using non-steroidal anti-inflammatory drugs (NSAIDs) or if you have had recent eye surgery.
You should also consult your healthcare professional first if you are using:
other non-steroidal anti-inflammatory drugs (NSAIDs)
Ketorolac eye drops contain the preservative benzalkonium chloride which may cause irritation and discolour soft contact lenses. If you are wearing soft contact lenses, these must be removed before inserting the eye drops and they should not be replaced for at least 15 minutes afterwards.
Children Ketorolac eye drops should not be prescribed for use in children. Other medicines and Ketorolac eye drops Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines including medicines obtained without a prescription. If you use Ketorolac eye drops with another eye medicine, leave at least 5 minutes between putting in Ketorolac eye drops and the other medicine. Pregnancy, breast-feeding and fertility
Ketorolac is not recommended for use during pregnancy and should not be used during breastfeeding. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines
Ketorolac eye drops may cause temporary blurred vision. Do not drive or use machinery until your vision has cleared. Ketorolac eye drops contains benzalkonium chloride This medicine contains 0.1 mg benzalkonium chloride in each milliliter which is equivalent to 0.1 mg/ml. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.
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BROWN & BURK UK LTD MODULE 1 ADMINISTRATIVE AND PRESCRIBING INFORMATION MODULE 1.3 PRODUCT INFORMATION KETOROLAC TROMETAMOL 0.5%w/v EYE DROPS, SOLUTION Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor. 3.
How to take it
Ketorolac eye drops
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is 1 drop into the affected eye(s), 3 times a day, starting 24 hours before surgery and continuing for up to 3 weeks after eye surgery. INSTRUCTIONS FOR USE You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it. Using the drops for the first time: These eye drops come in a bottle with a coned shaped nozzle and screw cap. The inside of the screw cap contains a spike. The screw cap is fitted to the bottle in such a way that there is no contact between the spike and the top of the nozzle of the bottle. In order to open the bottle it is necessary to tighten the screw cap further, so that the edge of the screw cap and the nozzle edge are totally aligned. At this point the screw cap spike will pierce the top of the nozzle of the bottle, which will open the bottle. Once the bottle has been opened in this way, unscrew the screw cap fully to remove it from the bottle and apply the eye drops. To avoid contamination, Do not touch or allow the dropper tip touch the eye, areas around the eye or any surface. It may become contaminated with bacteria that can cause eye infections leading to serious damage of the eye, even loss of vision. Opening the bottle before first use 1. Before using the medication for the first time, check that the tear-off tamper evident ring is intact and also that the safety ring connection with the cap has not been broken (Fig.1). You must not use the bottle if the tamper-evident rings on the bottle neck are broken or removed.
2. Before opening the bottle for the first time, tear off the tamper evident ring to break the seal (Fig.2).
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BROWN & BURK UK LTD MODULE 1 ADMINISTRATIVE AND PRESCRIBING INFORMATION MODULE 1.3 PRODUCT INFORMATION KETOROLAC TROMETAMOL 0.5%w/v EYE DROPS, SOLUTION 3. To open the bottle, remove the cap by turning it in the counterclockwise direction (Fig.3).
4. After opening the cap remove the safety ring gently (Fig. 4).
5. Place the cap and tighten the cap on the nozzle completely by turning clockwise. The spike in the cap will pierce the tip of the bottle. (Fig.5).
6. To open the bottle, remove the cap by turning it in the counterclockwise direction (Fig.6).
Using your eye drops 7. Wash your hands, tilt your head back and look at the ceiling (Fig.7).
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BROWN & BURK UK LTD MODULE 1 ADMINISTRATIVE AND PRESCRIBING INFORMATION MODULE 1.3 PRODUCT INFORMATION KETOROLAC TROMETAMOL 0.5%w/v EYE DROPS, SOLUTION 8. Gently pull the lower eyelid down to form a small pocket between the eyelid and the eye. (Fig. 8).
9. Turn the bottle upside down and squeeze it gently to release one drop into each eye that needs treatment. Do not touch your eye or eyelid with the dropper tip (Fig. 9). If a drop misses your eye, try again.
10. Let go of the lower lid, and close your eye for 30 seconds (Fig.10).
11. Reclose the bottle after use (Fig.11).
Wipe off any excess liquid from your cheek with a clean tissue. The proper application of your eye drops is very important. If you have any questions ask your doctor or pharmacist. If you use more Ketorolac eye drops than you should
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BROWN & BURK UK LTD MODULE 1 ADMINISTRATIVE AND PRESCRIBING INFORMATION MODULE 1.3 PRODUCT INFORMATION KETOROLAC TROMETAMOL 0.5%w/v EYE DROPS, SOLUTION The application of too many drops is unlikely to lead to unwanted side-effects. Apply your next dose at the normal time. If anyone drinks this medicine they should drink fluids to dilute the medicine in the stomach and contact their doctor for advice. If you forget to use Ketorolac eye drops If you forget a dose apply it as soon as you remember, unless it is almost time for your next dose, in which case you should miss out the forgotten dose. Then take your next dose as usual and continue with your normal routine. Do not use a double dose to make up for a forgotten dose. If you stop using Ketorolac eye drops Ketorolac Eye Drops should be used as advised by your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.
4.
Possible Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects
related to the cornea (the surface of the eye) may be more likely if Ketorolac Eye Drops is used for longer than two weeks or if you are using topical steroid drops at the same time or if you have a related eye condition. You should see your doctor immediately if you experience pain, increased irritation in the eye or changes in vision.
The very common side effects (may affect more than 1 in 10 people): –
Irritation of the eye stinging and/or burning in the eye eye pain.
Common side effects (may affect up to 1 in 10 people): –
allergic reactions, eye and/or eyelid swelling/puffiness itchy eyes red eye infection of the eye inflammation of the eye (surface or inside) bleeding of the retina swelling of central retina (light-sensitive layer of the eye) headache accidental injury caused by the tip of the dropper touching the eye increased pressure in the eye blurred and/or diminished vision.
Uncommon side effects (may affect up to 1 in 100 people): –
inflammation or damage to the front clear layer of the eye eye dryness and/or watery eyes
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BROWN & BURK UK LTD MODULE 1 ADMINISTRATIVE AND PRESCRIBING INFORMATION MODULE 1.3 PRODUCT INFORMATION KETOROLAC TROMETAMOL 0.5%w/v EYE DROPS, SOLUTION Not known side effects (frequency cannot be estimated from the available data): –
damage on the surface of the eye such as thinning erosion degradation of cell(s) difficulty in breathing or wheezing aggravation of asthma. ulcer-damage to the surface of the eye Eye swelling redness of eye (Ocular hyperaemia)
Reporting of side effects 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. You can also report side effects directly via Yellow Card Scheme at Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store it
Ketorolac eye drops
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the bottle label and carton after EXP. The expiry date refers to the last day of that month.
Throw the bottle away 28 days after opening, even if there is solution remaining. This product does not require any special storage conditions. Do not use Ketorolac eye drops if you notice the tamper-proof seal is broken. Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment. 6.
Contents of the pack and other information
What Ketorolac eye drops contains –
The active substance is Ketorolac Trometamol. The other ingredients are benzalkonium chloride, edetate disodium, octoxynol 40, sodium chloride, sodium hydroxide or hydrochloric acid (to adjust pH) and water for injection.
What Ketorolac eye drops looks like and contents of the pack Ketorolac Eye drops is a clear, colourless to pale yellow solution practically free from particles supplied in either a 3ml, 5 ml or 10 ml in White low density polyethylene (LDPE) container with translucent LDPE block nozzle and white high density polyethylene (HDPE) screw caps. Pack sizes: 1 x 3ml, 1 x 5ml, 3 x 5ml and 1 x 10ml. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer
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BROWN & BURK UK LTD MODULE 1 ADMINISTRATIVE AND PRESCRIBING INFORMATION MODULE 1.3 PRODUCT INFORMATION KETOROLAC TROMETAMOL 0.5%w/v EYE DROPS, SOLUTION Brown & Burk UK Ltd 5, Marryat Close Hounslow West Middlesex TW4 5DQ UK This leaflet was last revised in 04/2020
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Frequently asked questions about Ketorolac trometamol 0.5% w/v eye drops, solution
How do I take Ketorolac trometamol 0.5% w/v eye drops, solution?
Ketorolac trometamol 0.5% w/v eye drops, solution comes as eye drops. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Ketorolac trometamol 0.5% w/v eye drops, solution?
The active substance in Ketorolac trometamol 0.5% w/v eye drops, solution is ketorolac trometamol.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Ketorolac trometamol 0.5% w/v eye drops, solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Ketorolac trometamol 0.5% w/v eye drops, solution without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: ketorolac trometamol
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
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.
4.4. Special warnings and precautions for use
It is recommended that Ketorolac trometamol 0.5% w/v eye drops, solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
In common with other anti-inflammatory drugs, Ketorolac trometamol 0.5% w/v eye drops, solution may mask the usual signs of infection.
All non-steroidal anti-inflammatory drugs (NSAIDs) may slow down or delay wound healing. Concomitant use of NSAIDs and topical steroids can increase the potential for healing problems.
Concomitant use of Ketorolac trometamol 0.5% w/v eye drops, solution and topical corticosteroids should be exercised with caution in patients susceptible to corneal epithelial breakdown.
Use of topical NSAIDS may result in keratitis. In some patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.
Topical NSAIDs should be used with caution in patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g. dry eye syndrome), rheumatoid arthritis, or repeat ocular surgery within a short period of time, as they may be at increased risk for corneal adverse events which may become sight threatening.
Post marketing experience with topical NSAIDs also suggest that use more than 24 hours prior to surgery or use beyond 14 days post surgery may increase patient risk for the occurrence and severity of corneal adverse events.
The preservative in Ketorolac trometamol 0.5% w/v eye drops, solution, benzalkonium chloride, may cause eye irritation. Contact lenses must be removed prior to application, with at least a 15-minute wait before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses. Contact with soft contact lenses must be avoided.
This medicine contains 0.1 mg benzalkonium chloride in each milliliter which is equivalent to 0.1 mg/ml.
Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised.
There have been post-marketing reports of bronchospasm or exacerbation of asthma in patients, who have either a known hypersensitivity to aspirin/non steroidal anti-inflammatory drugs or a past medical history of asthma associated with the use of Ketorolac trometamol 0.5% w/v eye drops, solution, which may be contributory. Caution is recommended in the use of Ketorolac trometamol 0.5% w/v eye drops, solution in these individuals (see section 4.8)
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures to avoid injury and contamination of eye drops.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Ketorolac trometamol 0.5% w/v eye drops, solution have been safely administered with systemic and ophthalmic medications such as antibiotics, sedatives, beta blockers, carbonic anhydrase inhibitors, miotics, mydriatics, local anaesthetics and cycloplegics.
Ketorolac trometamol 0.5% w/v eye drops, solution may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical corticosteroids may increase the potential for healing problems (see section 4.4).
If Ketorolac trometamol 0.5% w/v eye drops, solution are used concomitantly with other topical eye medications there must be an interval of at least 5 minutes between the two medications.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no adequate data from the use of eye drops containing ketorolac trometamol in pregnant women. Studies in animals have shown reproductive toxicity. Inhibition of prostaglandin synthesis may negatively affect pregnancy and/or embryonal/foetal development and/ or postnatal development. Although a very low systemic exposure is expected after the use of ketorolac eye drops, Ketorolac trometamol 0.5% w/v eye drops is not recommended during pregnancy.
Breast-feeding
Ketorolac trometamol 0.5% w/v eye drops, solution should not be used during breast-feeding. Ketorolac trometamol is excreted in human milk after systemic administration.
Fertility
There are no adequate data from the use of ketorolac trometamol on fertility in humans.
4.7. Effects on ability to drive and use machines
Transient blurring of vision may occur on instillation of eye drops. Do not drive or use hazardous machinery unless vision is clear.
4.8. Undesirable effects
The most frequent adverse events reported with the use of Ketorolac trometamol 0.5% w/v eye drops, solution are transient stinging and burning on instillation.
The frequency of adverse reactions documented during clinical trials of ketorolac trometamol and through post-marketing experience is given below and is defined as follows:
Very common (≥1/10)
Common (≥1/100 to ≤ 1/10)
Uncommon (≥1/1,000 to ≤ 1/100)
Rare (≥1/10,000 to ≤ 1/1,000)
Very rare (≤ 1/10,000)
Not known (cannot be estimated from the available data).
Immune system disorders
Common: Hypersensitivity including localised allergic reactions
Nervous system disorders
Common: Headache
Eye Disorders
Very Common:
Eye irritation (including burning sensation)
Eye pain (including stinging)
Common:
Superficial (punctate) keratitis
Eye and/or eyelid oedema
Ocular pruritus
Conjunctival hyperaemia
Eye infection
Eye inflammation
Iritis
Keratic precipitates
Retinal haemorrhage
Cystoid macular oedema
Eye trauma
Increased intraocular pressure
Blurred and/or diminished vision
Uncommon:
Corneal ulcer
Corneal infiltrates
Eye dryness
Epiphora
Not known:
Corneal damage, e.g. thinning, erosion, epithelial breakdown and perforation*
Ulcerative keratitis
Eye swelling
Ocular hyperaemia
Respiratory, thoracic and mediastinal disorders
Not known:
Bronchospasm or exacerbation of asthma**
*Occasional post marketing reports of corneal damage including corneal thinning, corneal erosion, epithelial breakdown and corneal perforation have been received. These occurred mainly in patients using concomitant topical corticosteroids and/or with predisposing co-morbidity (see section 4.4).
**There have been post-marketing reports of bronchospasm or exacerbation of asthma, in patients, who have either a known hypersensitivity to aspirin/non-steroidal anti-inflammatory drugs or a past medical history of asthma, associated with the use of Ketorolac trometamol 0.5% w/v eye drops, solution which may be contributory.
None of the typical adverse reactions reported with the systemic non-steroidal anti-inflammatory agents (including ketorolac trometamol) have been observed at the doses used in topical ophthalmic therapy.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
There is no experience of overdose by the ophthalmic route. Overdose is unlikely to occur via the recommended method of administration.
If accidentally ingested, drink fluids to dilute.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Ketorolac trometamol. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- KETOROLAC TROMETAMOL MISOM 5 mg/ml prescription partial — not the same combinationKETOROLACUM TROMETHAMIN · eye / ear / nose
- KETOROLAC TROMETAMOL ROMPHARM 5 mg/ml prescription partial — not the same combinationKETOROLACUM TROMETHAMIN · eye / ear / nose
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- Ketorolac trometamol MisomKetorolacum trometamolum · eye / ear / nose
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Ketorolac trometamol 0.5% w/v eye drops, solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.