Prolensa - Consumer Medicine Information
|Manufacture:||Bausch and Lomb|
|Condition:||Postoperative Ocular Inflammation|
|Class:||Ophthalmic anti-inflammatory agents|
|Form:||Liquid solution, Eye drops (ophthalmic)|
|Ingredients:||bromfenac sodium sesquihydrate, benzalkonium chloride, boric acid, edetate disodium, povidone, sodium borate, sodium sulfite, tyloxapol, sodium hydroxide, sodium sulfite and water|
bromfenac ophthalmic solution 0.07%w/v (as bromfenac sodium sesquihydrate)
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 antiiflammatory medicines such as acetylsalicylic acid, difusinal, fenoprofen, flurbiprofen, ketoprofen, indomethacin, mefanaimc 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 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.
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.
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 14 days after first use.
How to Use
- Wash your hands well with soap and water before you start.
- Tilt your head back or lie down.
- Pull down your eyelid to create a “pocket” between the eyelid and the eye. The drop will go in here.
- Hold the bottle upside down, not touching the eye, and allow the drop to fall in the “pocket”.
- Let go of the eyelid, close the eye for about 30 seconds. Try not blink or squeeze your eyelids.
- Put the cap (top) back on the bottle.
- If a drop misses your eye, try again.
|In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
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.
Serious Side Effects, How Often They Happen and what to do about them
|Symptom / effect||Talk with your doctor, nurse or pharmacist||Stop taking drug and seek immediate medical help|
|Only if severe||In all cases|
|Common||inflammation of the eye||✓|
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 15°C - 25°C.
Discard any unused eye drops 14 days after first use.
Keep this medication out of the reach and sight of children.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701D
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
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.