How to take ELMIRON^®

Always take ELMIRON^® according to the instructions given to you by your doctor. The recommended dosage of ELMIRON^® is one capsule, 3 times a day, taken with water at least 1 hour before meals or 2 hours after meals

It is important that you don't stop taking ELMIRON^® or reduce your dosage just because you are feeling better or because ELMIRON^® is not working right away

Follow any other advice your doctor gives you for managing symptoms — for example, avoiding foods that may make your symptoms worse

While taking ELMIRON^®, avoid anticoagulant therapy such as warfarin sodium, heparin, high doses of aspirin or anti-inflammatory drugs, such as ibuprofen, until you speak with your doctor

If you are undergoing surgery, talk to your doctor about when to discontinue ELMIRON^® prior to surgery

You should talk to your doctor if you are pregnant or have any liver problems

What to expect

Symptom improvement with ELMIRON^® can be gradual and may take 3 to 6 months to notice relief. It's important to stay in contact with your doctor to discuss your progress over time.

If you have not experienced symptom improvement by 6 months of therapy, please talk to your doctor.

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

The Only Oral Medication FDA Approved to Treat the Bladder Pain or Discomfort of Interstitial Cystitis (IC)

About ELMIRON^®

How to take ELMIRON^®

What to expect