Prolensa: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

PROLENSA is a nonsteroidal anti-inflammatory drug (NSAID) used for treatment of pain and inflammation (swelling and redness) following cataract eye surgery.

What it does:

PROLENSA eye drops work by reducing the production of certain substances (for example, prostaglandins) that cause inflammation and pain.

When it should not be used:

PROLENSA should not be used if you are allergic (hypersensitive) to bromfenac, or any of its nonmedicinal ingredients (See What the nonmedicinal ingredients are), or to other nonsteroidal anti-inflammatory medicines such as acetylsalicylic acid, difusinal, fenoprofen, flurbiprofen, ketoprofen, indomethacin, mefenamic acid, piroxicam, sulindac, tiaprofenic acid or tolmetin.

PROLENSA contains sodium sulfite, which may cause allergic-type reactions. PROLENSA should not be used if you are allergic or sensitive to sulfite.

What the medicinal ingredient is:

Bromfenac sodium sesquihydrate

What the nonmedicinal ingredients are:

Benzalkonium chloride, boric acid, edetate disodium, povidone, sodium borate, sodium sulfite, tyloxapol, sodium hydroxide, sodium sulfite and water.

What dosage forms it comes in:

PROLENSA is supplied as a sterile bromfenac ophthalmic solution 0.07% w/v (as bromfenac sodium sesquihydrate) in white plastic, dropper-tipped, squeeze bottles of 0.6 mL for samples; 1.6 mL and 3 mL for commercial sizes.

WARNINGS AND PRECAUTIONS

BEFORE you use PROLENSA talk to your doctor or pharmacist if:

• you have an allergy or sensitivity to sodium sulfite
• you have any allergies to any medications

• you take any blood thinning medications, or if you have

  • any bleeding problems, or if you bruise easily
  • you are allergic to acetylsalicylic acid or to any other nonsteroidal anti-inflammatory drugs (NSAIDS)
  • you wear contact lenses

  • you are pregnant or intend to become pregnant

  • you are breastfeeding or intend to breast-feed
  • you have been recently had major ocular surgeries or repeated ocular surgeries within a short period of time,
  • you have corneal problems, ocular surface diseases (e.g., dry eye syndrome)
  • you suffer from diabetes mellitus or rheumatoid arthritis

  • your vision is blurred after taking PROLENSA, do not drive or operate machinery until your vision clears.

WHILE taking PROLENSA talk to your doctor if:

• you are not getting relief, your symptoms worsen, or new eye problems develop.

Do not use PROLENSA more than two weeks unless advised by your doctor. There is risk of corneal problems if ophthalmic nonsteroidal anti-inflammatory drugs such as PROLENSA are used beyond 14 days after the surgery.

In rare cases, you may experience a flare-up of inflammation after you stop taking PROLENSA, due to your cataract surgery. Your doctor may need to monitor your eyes for signs of macular oedema (a build up of fluid in the eye) after you stop taking PROLENSA.

INTERACTIONS WITH THIS MEDICATION

No specific drug interaction studies have been done for PROLENSA.

Tell your doctor or pharmacist if you are taking any blood-thinning medication.

PROPER USE OF THIS MEDICATION

Usual adult dose:

The day before cataract surgery, one drop of PROLENSA ophthalmic solution should be applied to the affected eye. On the day of cataract surgery, and for up to 14 days after cataract surgery, one drop of PROLENSA once daily should be applied to the affected eye. Follow your physician instructions.

If you are using other eye medicines as directed by your doctor, these medicines should be applied at least 5 minutes apart.

Proper Use:

PROLENSA should not be applied while wearing contact lenses. Remove contact lenses prior to applying PROLENSA. The preservative in PROLENSA, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 15 minutes after applying PROLENSA.

To minimise the chance of contamination of the content, replace the bottle cap immediately after use and avoid touching the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle. A single bottle of PROLENSA is used to treat only one eye.

Discard any unused eye drops 28 days after opening.

How to Use:

1. 1. Wash your hands well with soap and water before you start.
2. 2. Tilt your head back or lie down.
3. 3. Pull down your eyelid to create a “pocket” between the eyelid and the eye. The drop will go in here.
4. 4. Hold the bottle upside down, not touching the eye, and allow the drop to fall in the “pocket”.
5. 5. Let go of the eyelid, close the eye for about 30 seconds. Try not blink or squeeze your eyelids.
6. 6. Put the cap (top) back on the bottle.
7. 7. If a drop misses your eye, try again.

Overdose:

Missed Dose:

If a dose is missed, it should be applied as soon as possible.

Do not take 2 doses to make up for the missed dose.

If it is almost time for the next dose, the missed dose should be skipped, and you should go back to your regular dosing schedule.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The most common side effects experienced by patients taking PROLENSA were inflammation of the eye and eye pain.

This is not a complete list of side effects. For any unexpected effects while taking PROLENSA, contact your doctor or pharmacist.

HOW TO STORE IT

Store at room temperature between 15ºC - 25ºC.

Discard 28 days after opening.

Keep this medication out of the reach and sight of children.

Reporting Side Effects

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found on the Health Canada website

or by contacting the sponsor, Bausch & Lomb Incorporated, at:

1-888-459-5000 or at http:www.bausch.ca.

Last revised: December 8, 2020