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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. 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?

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. Weight gain and swelling caused by fluid buildup in the body have also been reported in patients taking ELMIRON^®. Call your doctor if 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.

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 see full Prescribing Information and read the Patient Leaflet.

080475-170915

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