PROLENSA (bromfenac ophthalmic solution) 0.07%



                                                  Important Safety Information





INDICATION AND USAGE

PROLENSA (bromfenac ophthalmic solution) 0.07% is a nonsteroidal anti-inflammatory drug (NSAID) indicated to treat inflammation and reduce eye pain in patients after cataract surgery.

IMPORTANT SAFETY INFORMATION ABOUT PROLENSA

  • PROLENSA contains sodium sulfite, a substance that may cause allergic reactions, some severe, in certain people. In addition, tell your doctor if you have had an allergic reaction to any other medications.

  • Slow or delayed healing may occur while using non-steroidal anti-inflammatory drugs (NSAIDs) such as PROLENSA.

  • Use of NSAIDs in the eye may result in certain serious eye conditions that can be sight threatening. Tell your doctor immediately about any side effect that you may have.

  • Replace bottle cap after using and do not touch dropper tip to any surface in order to avoid contamination of the bottle.

  • Remove contact lenses prior to using PROLENSA. The preservative in PROLENSA, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of PROLENSA.

  • If more than one eye medicine is being used, use the eye medicines at least 5 minutes apart.

  • The most common side effects (seen in 3%-8% of patients) were inflammation of the eye, foreign body sensation, eye pain, light sensitivity, and blurred vision.

Please click here for full Prescribing Information about PROLENSA.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call
1-800-FDA-1088.

PRA.0022.USA.17