Acular

Package leaflet: Information for the user

ACULAR 0.5% w/v eye drops, solution

(Ketorolac tromethamine)
Please read this leaflet carefully before using this medicine because it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor has told you to.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What ACULAR is and what it is used for
2. What you need to know before using ACULAR
3. How to use ACULAR
4. Possible side effects
5. How to store ACULAR
6. Contents of the pack and other information

1. What ACULAR 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).

2. What you need to know before using ACULAR

Do not use ACULAR

• If you are allergic to ketorolac tromethamine or to any of the excipients of this medicine (listed in section 6).
• If you are allergic to aspirin or to any other similar medicines, such as other non-steroidal anti-inflammatory drugs (NSAIDs).

Warnings and precautions
Consult your doctor or pharmacist before using ACULAR.
If you currently have or have previously had:

• viral or bacterial eye infections
• a tendency to bleeding (e.g., anemia) or stomach ulcers
• diabetes
• rheumatoid arthritis
• dry eye syndrome
• asthma after taking non-steroidal anti-inflammatory drugs
• recent eye surgery
• reduced corneal sensitivity (the clear surface covering the pupil and iris) or damage to the normally smooth corneal surface.

Children
ACULAR should not be prescribed for use in children.
ACULAR and other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you use ACULAR together with other eye medications, wait at least 5 minutes between administering ACULAR and another medicine.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
ACULAR must not be used if you are pregnant or breastfeeding, unless specifically recommended by your doctor.
Driving and operating machinery
In some patients, ACULAR may cause blurred vision. Do not drive or operate machinery while symptoms persist.
ACULAR 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 cause a change in their colour. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or corneal disorders (conditions affecting the transparent outer layer of the eye). If you experience an unusual sensation, burning, or pain in the eye after using this medicine, speak with your doctor.

3. How to use ACULAR

Always use ACULAR exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. The recommended dose is one drop into the affected eye three times a day for 3–4 weeks, starting 24 hours before cataract surgery.

Instructions for use
Apply the eye drops as follows:

1. Wash your hands. Tilt your head backward and look upward.
2. Gently pull down the lower eyelid to form a small pocket.
3. Invert the bottle and gently squeeze to release one drop into each eye to be treated.
4. Release the lower eyelid and keep the eye closed for 30 seconds. If a drop runs out of the eye, repeat the procedure. To avoid contamination or injury, do not let the dropper tip touch the eye or any other surface. After use, close the bottle tightly and replace the cap. Wipe away any excess liquid on the cheek with a clean tissue. It is very important that the application is performed correctly. If you have any questions or need clarification, ask your doctor or pharmacist.

If you use more ACULAR than you should
Applying more drops than recommended is unlikely to cause adverse effects. Apply the next prescribed dose at the usual time. If the product is accidentally swallowed, drink fluids to dilute it and contact your doctor.

If you forget to use ACULAR
If you forget to apply a dose, apply it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and take the next one at the regular time. Do not apply a double dose to make up for a forgotten dose.

If you stop using ACULAR
If you have any doubts about using ACULAR, consult your doctor or pharmacist.

4. 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, sensation of stinging and/or burning 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, eye inflammation (on the surface or inside), retinal bleeding, swelling of the central retina (light-sensitive layer of the eye), headache, accidental injury caused by contact of the dropper tip with the eye, increased eye pressure, blurred vision and/or decreased vision.
Uncommon (may affect up to 1 in 100 people):
Inflammation or damage to the clear front layer of the eye, dry eye and/or excessive 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 the cell(s), breathing difficulty or wheezing, worsening of asthma, facial swelling, ulceration – damage to the surface of the eye.
Side effects related to the cornea (the surface of the eye) may be more likely if ACULAR is used for more than two weeks, or if topical steroid eye drops are used concomitantly, or if you have an associated eye disease. Contact your doctor immediately if you experience pain, increased eye irritation, or changes in vision.

Reporting of side effects
If you experience any side effects, including those 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/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

3. How to store ACULAR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle label and carton after EXP. The expiry date refers to the last day of the month.
Discard the bottle 28 days after first opening, even if some solution remains.
Store below 25°C.
Do not use this medicine if you notice any breakage of the safety seal.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

4. Pack contents and other information

What ACULAR contains

• The active substance is Ketorolac trometamol 0.5% w/v.
• The excipients are: benzalkonium chloride, edetate disodium, octoxynol 40, sodium chloride, sodium hydroxide or hydrochloric acid (to adjust pH), and purified water.

Description of the appearance of ACULAR and pack contents
ACULAR is an eye drop solution, a clear, colourless to pale yellow liquid contained in a plastic bottle.
Each pack contains one 10 ml plastic bottle with a screw cap.
Each bottle contains either 5 ml or 10 ml of eye drops. Not all pack sizes may be marketed.

Marketing Authorisation Holder
AbbVie S.r.l.
S.R. 148 Pontina km 52 snc
04011 Campoverde di Aprilia (LT)
Italy

Manufacturer
Allergan Pharmaceuticals Ireland, Westport, Co. Mayo, Ireland

This medicinal product is authorised in the European Economic Area Member States under the following names:

This patient information leaflet was last approved on