ACULAR*EYE DROPS 5ML 0.5%

ACULAR 0.5% w/v eye drops, solution
Ketorolac tromethamine

What it is and what it is used for
ACULAR is used for the prophylaxis and reduction of ocular inflammation following cataract surgery in adults.
ACULAR belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).

What you need to know before taking the medicine
Do not use ACULAR:
- if you are allergic to ketorolac tromethamine or any of the other ingredients of this medicine (listed in section 6);
- if you are allergic to aspirin or any similar medicine, such as other non-steroidal anti-inflammatory medicines.

Warnings and precautions
Talk to your doctor or pharmacist before using ACULAR.
If you suffer or have suffered in the past from:
- viral or bacterial eye infections;
- bleeding tendencies (e.g., anemia) or stomach ulcers;
- diabetes;
- rheumatoid arthritis;
- dry eye syndrome;
- asthma after using non-steroidal anti-inflammatory drugs;
- if you have recently undergone eye surgery;
- if you have lost sensation in your cornea (the clear surface covering the pupil and iris) or if the normally smooth surface of your cornea is damaged.

Children and adolescents
ACULAR should not be prescribed for use in children.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people):
• eye irritation;
• stinging and/or burning sensation in the eye;
• eye pain.

Common (may affect up to 1 in 10 people):
• allergic reaction;
• swelling/edema of the eye and/or eyelid;
• itchy eyes;
• red eyes;
• eye infection;
• ocular inflammation (superficial or internal);
• formation of small deposits on the clear surface at the front of the eye;
• retinal hemorrhage;
• swelling of the central retina (light-sensitive layer of the eye);
• headache;
• accidental injury caused by contact with the eye of the dropper tip;
• increased eye pressure;
• blurred and/or decreased vision.

Uncommon (may affect up to 1 in 100 people)
• inflammation or damage to the transparent anterior layer of the eye;
• dry eyes and/or tearing.

Not known (frequency cannot be estimated from the available data):
• damage to the surface of the eye such as thinning;
• erosion;
• perforation;
• deterioration of cells;
• shortness of breath or wheezing;
• worsening of asthma;
• facial swelling;
• ulcer-damage to the surface of the eye.

Corneal (eye surface) side effects are more likely to occur if ACULAR is used for more than two weeks, if topical steroid eye drops are used concomitantly, or if you have a related eye disease. Consult your doctor immediately if you experience pain, increased eye irritation, or changes in vision.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.