Ketorolac trometamol misom

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Ketorolac trometamol Misom, 5 mg/mL, eye drops, solution
Ketorolacum trometamolum
Please read this leaflet carefully before using the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

1. What Ketorolac trometamol Misom is and what it is used for
2. Important information before using Ketorolac trometamol Misom
3. How to use Ketorolac trometamol Misom
4. Possible side effects
5. How to store Ketorolac trometamol Misom
6. Contents of the pack and other information

1. What Ketorolac trometamol Misom is and what it is used for
Ketorolac trometamol Misom is used to prevent and reduce ocular inflammation after cataract surgery in adults. Ketorolac trometamol Misom belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).

2. Important information before using Ketorolac trometamol Misom

When not to use Ketorolac trometamol Misom

• If you are allergic to ketorolac tromethamine or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to acetylsalicylic acid or to any other non-steroidal anti-inflammatory drug.

Warnings and precautions
Before starting Ketorolac trometamol Misom, consult your doctor, pharmacist, or nurse if you currently have or have had in the past:

• Viral or bacterial eye infections
• A tendency to bleeding (e.g. anaemia) or gastric ulcers
• Diabetes
• Rheumatoid arthritis
• Dry eye syndrome
• Asthma triggered by non-steroidal anti-inflammatory drugs
• Recent eye surgery
• Corneal hypoesthesia (reduced sensitivity of the cornea, the transparent layer covering the pupil and iris) or if the normally smooth corneal surface is damaged.

Children
Ketorolac trometamol Misom should not be used in children.

Ketorolac trometamol Misom and other medicines
Inform your doctor about all medicines you are currently using, have recently used, or plan to use.
If you are using other eye drops at the same time as Ketorolac trometamol Misom, wait at least 5 minutes between administering Ketorolac trometamol Misom and the next medicine.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Ketorolac trometamol Misom should not be used in pregnant or breastfeeding women unless specifically advised by a doctor.

Driving and operating machinery
Ketorolac trometamol Misom may cause blurred vision in some patients. Do not drive or operate machinery until symptoms have resolved.

Ketorolac trometamol Misom contains benzalkonium chloride.
This medicine contains 0.1 mg of benzalkonium chloride per millilitre, equivalent to 0.1 mg/mL.
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their colour. Remove contact lenses before using this medicine and reinsert them after 15 minutes.
Benzalkonium chloride may also cause eye irritation, particularly in cases of dry eyes or corneal disorders (abnormalities of the transparent layer at the front of the eye). If you experience any unusual sensation in the eye, such as stinging or eye pain after using this medicine, contact your doctor.

3. How to use Ketorolac trometamol Misom

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose is 1 drop into the affected eye 3 times daily for 3-4 weeks after cataract surgery,
starting 24 hours before surgery.
Instructions for use
Eye drops should be used as follows:

1. Wash your hands. Tilt your head backward and look upward at the ceiling.
2. Gently pull the lower eyelid downward to form a small pocket.
3. Turn the container upside down and squeeze it to instill one drop into each eye requiring treatment.
4. Release the lower eyelid and close the eye for 30 seconds.

If the drop misses the eye, try again.
To avoid contamination or injury, do not let the dropper tip touch the eye or any other surface.
Replace and tighten the cap immediately after use.
Wipe away any excess liquid from the cheek with a clean tissue.
Proper administration of eye drops is very important.
If you have any questions, consult your doctor or pharmacist.
Taking more Ketorolac trometamol Misom than recommended
Using too many drops is unlikely to cause adverse effects. Take the next dose at the usual time. If someone accidentally swallows this medicine, they should drink fluids to dilute it and contact a doctor.
If you forget to use Ketorolac trometamol Misom
If you miss a dose, use it as soon as you remember, unless it is almost time for the next dose. In that case, skip the missed dose and take the next dose at the regular time. Continue your normal dosing schedule.
Do not use a double dose to make up for a missed dose.
Stopping Ketorolac trometamol Misom
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Very common (more than 1 in 10 people):
Eye irritation, stinging and/or burning in the eye, eye pain.

Common (more than 1 in 10 people):
Allergic reaction, swelling/edema of the eyes and/or eyelids, itching of the eyes, redness of the eyes, eye infection, eye inflammation (superficial or internal), retinal hemorrhage, swelling of the central part of the retina (the light-sensitive layer of the eye), headache, accidental injury caused by touching the eye with the dropper tip, increased intraocular pressure, blurred and/or worsened vision.

Uncommon (more than 1 in 100 people):
Inflammation or damage to the front transparent layer of the eye, dry eye and/or watery eyes.

Frequency not known (cannot be estimated from the available data):
Damage to the surface of the eye, such as thinning, erosion, perforation, cell degradation, breathing difficulties or wheezing, worsening of asthma, facial swelling, ulceration of the surface of the eye.

Adverse reactions affecting the cornea (surface of the eye) may be more likely when ketorolac trometamol is used for longer than two weeks, when used concomitantly with topical steroid eye drops, or in patients with similar eye diseases. You should contact your doctor immediately if you experience pain, severe eye irritation, or changes in vision.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder or representative of the marketing authorization holder.

By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Ketorolac trometamol Misom

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container and carton following the abbreviation EXP. The expiry date refers to the last day of the specified month.
Discard the bottle 28 days after opening, even if the contents have not been completely used.
This product does not require any special storage conditions.
Do not use this medicine if the tamper-evident seal is broken.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Ketorolac trometamol Misom contains

• The active substance is ketorolac tromethamine 0.5% w/v.
• The other ingredients are: benzalkonium chloride, disodium edetate, octoxynol 40, sodium chloride, sodium hydroxide or hydrochloric acid (concentrated) (for pH adjustment), and water for injections.

What Ketorolac trometamol Misom looks like and contents of the pack
Ketorolac trometamol Misom is a clear, colourless to pale yellow solution, practically free from
particles, supplied in 5 mL or 10 mL containers with dropper made of white low-density polyethylene (LDPE), with a white, opaque, open nozzle made of LDPE and grey caps made of high-density polyethylene (HDPE).
For the 5 mL container: the approximate number of drops in the container is 160.
For the 10 mL container: the approximate number of drops in the container is 320.
Pack sizes: 1 x 5 mL, 3 x 5 mL and 1 x 10 mL.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Brown & Burk IR Limited
22 Northumberland Road,
Ballsbridge, Dublin 4, Ireland

Manufacturer
Eurofins Analytical Services Hungary Kft.
Anonymus u.6,
Budapest, 1045,
Hungary

This medicinal product is authorised in the European Economic Area under the following names:
Czech Republic: Ketorolac trometamol Misom
Denmark: Ketorolac trometamol Misom
Poland: Ketorolac trometamol Misom
Romania: Ketorolac trometamol Misom 5 mg/mL ophthalmic drops, solution