Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Prolensa (Bromfenac-opht). If you are concerned about side effects, discuss the risks and benefits of Prolensa (Bromfenac-opht) with your doctor. The following side effects have been reported by at least 1% of people taking Prolensa (Bromfenac-opht). Many of these side effects can be managed, and some may go away on their own over time.

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• eye inflammation
• eye pain
• feeling of something in your eye

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of macular edema (swelling and fluid build-up in the centre of the Retin A, blurry vision, blurry or wavy vision near or in the centre of the field of vision, faded colours)
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Prolensa (Bromfenac-opht).

Each mL of topical ophthalmic solution contains 0.805 mg of bromfenac sodium sesquihydrate, equivalent to 0.7 mg of bromfenac free acid. Nonmedicinal ingredients: boric acid, edetate disodium, povidone, sodium borate, sodium sulfite, tyloxapol, sodium hydroxide to adjust pH, benzalkonium chloride 0.005% (as preservative), and water for injection (or purified water).

Do not use Prolensa (Bromfenac-opht) if you:

• are allergic to bromfenac or any ingredients of the medication
• are allergic or sensitive to other NSAIDs (e.g., Naproxen, acetylsalicylic acid [Asa], Diclofenac)

There may be an interaction between bromfenac and any of the following:

• corticosteroid eye drops
• prostaglandin eye drops (e.g., Bimatoprost, Latanoprost, Travoprost)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Prolensa (Bromfenac-opht). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Prolensa (Bromfenac-opht).

Allergies: If you have had an Asthma attack, severe itching, or other allergic reactions after taking acetylsalicylic acid (ASA) or other nonsteroidal anti-inflammatory drugs (e.g., Ibuprofen, naproxen) you may also be allergic to bromfenac eye drops. Let your ophthalmologist and surgeon know if you may be allergic to ASA or other NSAIDs.

Contact lenses: The preservative in these eye drops may be absorbed by certain contact lenses. If you wear contact lenses, remove your contact lenses before using these eye drops. You can put your contact lenses back in after 15 minutes.

Bleeding: If you are having surgery and bleed easily or are taking medications that prolong bleeding (e.g., Warfarin), discuss with your doctor how Prolensa (Bromfenac-opht) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Prolensa (Bromfenac-opht), and whether any special monitoring is needed.

Blurred vision: Prolensa (Bromfenac-opht) may temporarily cause blurred vision. Do not drive or operate machinery until your vision has cleared.

Rarely, fluid may build up in the part of your eye called the macula, which is part of the retina. If you experience blurred or wavy vision after stopping the eye drops, contact your eye doctor as soon as possible.

Inflammation of the cornea: As with other anti-inflammatory eye drops, bromfenac can cause irritation and damage to the cornea (keratitis). In severe cases, this can lead to permanent vision problems or blindness. If you experience unusual pain, the sensation of something in your eye, unusual sensitivity to sunlight or other changes to your eye, contact your doctor immediately.

This may be more likely to occur if you have Diabetes, other eye conditions such as dry eye syndrome, Rheumatoid Arthritis, or repeat eye surgeries during short period of time.

Wound healing: Bromfenac eye drops may slow or delay the healing of wounds. The risk of delayed healing increases if you have complicated eye surgeries, disorders of the cornea, diabetes, rheumatoid arthritis, or several eye surgeries in a short time. Talk to your doctor if you have any concerns.

Pregnancy: Prolensa (Bromfenac-opht) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Prolensa (Bromfenac-opht), contact your doctor immediately.

Breast-feeding: It is not known if bromfenac passes into breast milk. If you are a breast-feeding mother and are taking Prolensa (Bromfenac-opht), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Prolensa (Bromfenac-opht) have not been established for children.