Prolensa (ophthalmic)

Prolensa is a non-steroidal anti-inflammatory drug (NSAID).

Prolensa (for the eyes) is used to relieve swelling and pain that occur after cataract surgery.

Prolensa may also be used for reasons not mentioned in this medication guide.

You should not use Prolensa if you are allergic to it.

Tell your doctor if you have ever had:

• asthma or sulfite allergy;
• diabetes;
• rheumatoid arthritis;
• dry eye syndrome;
• an allergy to aspirin or other NSAIDs;
• a bleeding or blood-clotting disorder; or
• more than one eye surgery in a short period of time.

If you are pregnant, you should not use Prolensa unless your doctor tells you to. Using an NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

Tell your doctor if you are breastfeeding.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Prolensa may cause serious side effects. Stop using Prolensa and call your doctor right away if you have:

• any change in your vision;
• slow healing after your eye surgery;
• eye redness or bleeding;
• eye pain or swelling; or
• severe eye discomfort, increased tears, crusting or drainage.

Common side effects of Prolensa may include:

• increased sensitivity of your eyes to light;
• mild eye irritation, or a feeling like something is in your eye;
• headache; or
• seeing flashes of light or "floaters" in your vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label. Do not use this medication for more than the number of days your doctor has recommended. Using an NSAID eye drop too long can increase your risk of serious side effects that may damage your vision.

Do not use Prolensa while wearing contact lenses. This medicine may contain a preservative that can discolor soft contact lenses. Wait at least 10 minutes after using Prolensa before putting in your contact lenses.

The Prolensa brand of bromfenac ophthalmic is usually given as 1 drop in each affected eye once daily for 14 days.

The Bromsite brand of bromfenac ophthalmic is usually given as 1 drop in each affected eye twice daily for 14 days.

Use only the number of drops your doctor has prescribed.

Wash your hands before using eye medication.

To apply the eye drops: Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye and squeeze a drop into this pocket. Close your eyes for 1 or 2 minutes.

Do not touch the tip of the eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your pharmacist for new medicine.

Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.

Use the medicine as soon as you can, but if it is almost time for your next dose, skip the missed dose. Do not use two doses at the same time.

Call your doctor for instructions if you miss your first dose, which should be given 1 day before surgery.

An overdose of Prolensa (ophthalmic) is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Prolensa (ophthalmic) may cause blurred vision and may impair your reactions. Avoid driving or doing anything dangerous until you know how this medicine will affect you.

Do not use other eye medications unless your doctor tells you to.

Medicine used in the eyes is not likely to be affected by other drugs you use. However, many drugs can interact with each other. Inform all your healthcare providers about all the medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.