BromSite contains the active ingredient bromfenac sodium sesquihydrate in an ophthalmic solution form. It is classified as a non-steroidal anti-inflammatory drug (NSAID) and is administered topically in the eye. The formulation includes bromfenac sodium sesquihydrate at a concentration of 0.075%, with benzalkonium chloride and other inactive ingredients to maintain stability and pH.

How should I use this medication?

This medication is only for use in the eye. Do not take by mouth. Follow the directions on the prescription label. Remove contact lenses before use. Wash hands before and after use. Tilt your head back slightly and pull your lower eyelid down with your index finger to form a pouch. Try not to touch the tip of the dropper to your eye, fingertips, or any other surface. Squeeze the prescribed number of drops into the pouch. Close the eye gently to spread the drops. Your vision may blur for a few minutes. Use your doses at regular intervals. Do not use your medication more often than directed.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 15 and 25 degrees C (59 and 77 degrees F). Throw away any unused medication after the expiration date on the label.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding in the front of the eye, including the white, iris, or pupil
• Change in vision such as blurry vision, seeing halos around lights, vision loss
• New or worsening eye pain, redness, irritation, or discharge

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Blurry vision
• Irritation at application site
• Increased tears after use

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Asthma
• Bleeding problems
• Diabetes
• Dry eye syndrome, other eye problems, or recent eye surgery
• Wear soft contact lenses
• An unusual or allergic reaction to bromfenac, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

What may interact with this medication?

• Agents that may increase bleeding time such as warfarin or other blood thinners
• Corticosteroid eye drops or ointments

Do not use any other eye products without asking your care team.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your care team if your eye symptoms do not get better within 2 to 3 days. Do not use for longer than directed by your care team.

Unless your care team gives you other instructions, you should not wear contact lenses while you are using this medication. If it is okay to wear your lenses, then wait 10 minutes after using this medication before inserting your lenses.