Bromfenac Sodium Ophthalmic drops, solution

What is this medicine?

BROMFENAC (BROM fen ak) is a non-steroidal anti-inflammatory drug (NSAID). The eye drops are used to treat pain and swelling after eye surgery.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

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, aspirin, other NSAIDS, sulfites, other medicines, foods, dyes or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine 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 medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine 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.

What may interact with this medicine?

• 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 doctor or health care professional.

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 medicine?

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

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

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• bleeding in the white part of your eye

• breathing problems

• sores in the eye or eye irritation that gets worse

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

• burning or stinging after instilling the drops

• dry, red, or itchy eyes

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.

Where should I keep my medicine?

Keep out of the reach of children.

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