IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ELMIRON^® (pentosan polysulfate sodium) Capsules?

You must take ELMIRON^® as prescribed by your doctor in the dosage prescribed but no more frequently than prescribed.

Pigment changes in the retina of the eye (also referred to as pigmentary maculopathy in medical journal articles) have been reported with long-term use of ELMIRON^®. While the cause of the pigmentary changes is unclear, continued long-term dosing with ELMIRON^® may be a risk factor. The consequences of these pigmentary changes in the retina are not fully understood.

Visual symptoms that have been reported include: difficulty reading, slow adjustment to low or reduced light environments, and blurred vision. If you already have retinal pigment changes from other causes, it may be difficult to distinguish future retinal pigment changes if they occur.

Call your doctor (including your eye doctor) if you notice any changes in your vision.

Throughout your treatment, regular eye examinations that include retinal examinations are suggested for early detection of retinal/macular changes. Your doctor will discuss with you when to get your first eye examination and follow-up exams, and whether the treatment should be continued since these changes may be irreversible and may progress even after stopping treatment.

ELMIRON^® is a weak anticoagulant (blood thinner) which may increase bleeding.

Call your doctor if you will be undergoing surgery or will begin taking anticoagulant therapy such as warfarin sodium, heparin, high doses of aspirin, or anti-inflammatory drugs such as ibuprofen.

Who should not take ELMIRON^®?

Patients undergoing surgery should speak with their doctor about when to discontinue ELMIRON^® prior to surgery.
ELMIRON^® should be used during pregnancy only if clearly needed.

What does your doctor need to know?

Tell your doctor if you have a personal or family history of eye problems of the retina.
Tell your doctors (including your eye doctor) if you experience visual changes such as reading difficulty, slower adjustment to low or reduced light, or blurred vision. (See “WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ELMIRON^®?”)
If you are taking anticoagulant therapy such as warfarin sodium, heparin, high doses of aspirin, or anti-inflammatory drugs such as ibuprofen.
If you are pregnant.
If you have any liver problems.

What should I avoid while taking ELMIRON^®?

Anticoagulant therapy such as warfarin sodium, heparin, high doses of aspirin, or anti-inflammatory drugs such as ibuprofen until you speak with your doctor.

What are the most common side effects of ELMIRON^®?

The most common side effects are hair loss, diarrhea, nausea, blood in the stool, headache, rash, upset stomach, abnormal liver function tests, dizziness, and bruising.

Call your doctor if any of these side effects persist or are bothersome or if there is blood in your stool or if you have any other side effect that bothers you or that does not go away.

Keep out of reach of children.

You are also encouraged to report side effects to the FDA: visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).

Please click here to see full Prescribing Information and read the Patient Leaflet.

cp-11575v3

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