FULL PRESCRIBING INFORMATION

Taking a new medication is a big step.

If ELMIRON^® has already been prescribed for you, or if you think you may get a prescription for ELMIRON^® in the future, you can view and print the full Product Information for ELMIRON^® right here.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Follow the link to download the full ELMIRON^® Product Information.

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ELMIRON^® is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis.
ELMIRON^® is available by prescription only.

IMPORTANT SAFETY INFORMATION

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, heparin, high doses of aspirin, or anti-inflammatory drugs such as ibuprofen.

ELMIRON^® should not be taken if you have a known hypersensitivity to the drug or similar drugs.

The most common side effects observed in clinical trials were blood in stool, diarrhea, nausea, hair loss, headache, rash, upset stomach, abdominal pain, liver function abnormalities, and dizziness. Hair loss, when it occurred, was almost always limited to a single area of the scalp, and grew back when ELMIRON^® was discontinued.

The mechanism of action of ELMIRON^® in interstitial cystitis is not fully understood.

Please see full Product Information for ELMIRON^®.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

© Ortho-McNeil-Janssen Pharmaceuticals, Inc. 2009. All rights reserved. Your use of the information on this site is subject to the terms of our Legal Notice. This site is published by Ortho Women's Health & Urology™, Division of Ortho-McNeil-Janssen

ELMIRON^® is a registered trademark of IVAX Research, Inc, under license to Ortho-McNeil-Janssen Pharmaceuticals, Inc.

This information is intended for use by our customers, patients and healthcare professionals in the United States only. Ortho Women's Health & Urology™ recognizes that the Internet is a global communications medium; however, laws, regulatory requirements and medical practices for pharmaceutical products vary from country to country. The Full Product Information included here may not be appropriate for use outside the United States.
Last modified November 12, 2009