Uses of Prolensa:

• It is used to treat swelling and pain after cataract surgery.

What do I need to tell my doctor BEFORE I take Prolensa?

• If you have an allergy to bromfenac or any other part of Prolensa (bromfenac).
• If you are allergic to Prolensa (bromfenac); any part of Prolensa (bromfenac); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are more than 24 weeks pregnant.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Prolensa (bromfenac) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Prolensa?

• Tell all of your health care providers that you take Prolensa (bromfenac). This includes your doctors, nurses, pharmacists, and dentists.
• If you are allergic to sulfites, talk with your doctor. Some products have sulfites.
• Do not use Prolensa (bromfenac) for longer than you were told by your doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Prolensa (bromfenac) while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Prolensa) best taken?

Use Prolensa (bromfenac) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• For the eye only.
• Take out contact lenses before using Prolensa (bromfenac). Talk with your doctor to see if contact lenses may be put back in after you use Prolensa (bromfenac). Do not put contacts back in if your eyes are irritated or infected.
• Wash your hands before and after use.
• Do not touch the container tip to the eye, lid, or other skin.
• Tilt your head back and drop drug into the eye.
• If more than 1 drug is being used in the same eye, use each drug at least 5 minutes apart.
• If Prolensa (bromfenac) is being used after surgery on both eyes, do not use the same bottle for both eyes. Your doctor may order 2 eye drop bottles; one for each eye. Make sure you do not mix the 2 bottles up.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in eyesight, eye pain, or very bad eye irritation.
• Bleeding in the eye.

What are some other side effects of Prolensa?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Eye irritation.
• Burning.
• Stinging.
• Redness.
• Feeling that something is in the eye.
• Blurred eyesight.
• Bright lights may bother you. Wear sunglasses.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Prolensa?

• Store at room temperature.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Prolensa (bromfenac), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.