ELMIRON- pentosan polysulfate sodium capsule, gelatin coated 
Janssen Pharmaceuticals, Inc.

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This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 03/2021
MEDICATION GUIDE

ELMIRON ® (EL ma ron)

(pentosan polysulfate sodium)

capsules, for oral use

What is the most important information I should know about ELMIRON?

Serious side effects have been reported with the use of ELMIRON, including:

  • Changes in the retina of the eye (pigmentary maculopathy). Taking ELMIRON may be associated with pigment changes in the retina of the eye that may continue even after stopping treatment with ELMIRON. Tell your healthcare provider including your eye doctor right away if you have any vision changes including any of these symptoms:
  • difficulty reading
  • your vision takes longer to adjust to low or reduced light
  • blurred 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.
  • Increased bleeding. ELMIRON may increase bleeding. Tell your healthcare provider right away if you have any of these symptoms:
  • bruising easily
  • nosebleeds
  • bleeding gums
  • blood in your stool
Your risk of bleeding may be increased if you take ELMIRON along with other medicines such as:
  • warfarin sodium
  • heparin
  • high doses of aspirin
  • anti-inflammatory medicines such as ibuprofen
Tell your healthcare provider if you are taking any of these medicines.

Before you start taking ELMIRON, tell your healthcare provider if you are going to have surgery. Your healthcare provider may stop ELMIRON before you have surgery. Talk to your healthcare provider about when to stop taking ELMIRON and when to start taking it again.
What is ELMIRON?
  • ELMIRON is a prescription medicine used to treat bladder pain or discomfort associated with interstitial cystitis.
  • It is not known if ELMIRON is safe and effective in children under 16 years of age.
Do not take ELMIRON if you:
  • are allergic to pentosan polysulfate sodium or any of the ingredients in ELMIRON. See the end of this Medication Guide for a complete list of ingredients in ELMIRON.
Before your take ELMIRON, tell your healthcare provider about all of your medical conditions, including if you:
  • have a personal or family history of eye problems of the retina.
  • have a history of aneurysms.
  • have problems with easy bleeding (thrombocytopenia).
  • have hemophilia.
  • have gastrointestinal problems such as ulcerations, polyps, or diverticula.
  • have liver problems
  • are pregnant or plan to become pregnant. ELMIRON should be used during pregnancy only if clearly needed. Tell your healthcare provider if you become pregnant while taking ELMIRON. You and your healthcare provider should decide if you should continue to take ELMIRON.
  • are breastfeeding or plan to breastfeed. It is not known if ELMIRON passes into your breastmilk. You and your healthcare provider should decide if you will take ELMIRON or breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take ELMIRON?
  • Take ELMIRON exactly as your healthcare provider tells you to take it.
  • Take 1 capsule of ELMIRON by mouth 3 times a day with water at least 1 hour before meals or 2 hours after meals. Each capsule contains 100 mg of ELMIRON.
  • If you take too much ELMIRON, call your healthcare provider right away or go to the nearest emergency room.
What are the possible side effects of ELMIRON?

Serious side effects have been reported with the use of ELMIRON, including:

Changes in the retina of the eye

Increased bleeding

(See " What is the most important information I should know about ELMIRON?")

The most common side effects of ELMIRON are:
  • hair loss
  • diarrhea
  • nausea
  • stomach pain
  • upset stomach
  • headache
  • rash
  • abnormal liver function tests
  • dizziness
These are not all of the possible side effects of ELMIRON.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ELMIRON?
  • Store ELMIRON at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep ELMIRON and all medicines out of the reach of children.
General information about the safe and effective use of ELMIRON.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ELMIRON for a condition for which it was not prescribed. Do not give ELMIRON to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ELMIRON that is written for health professionals.
What are the ingredients in ELMIRON?

Active ingredient: pentosan polysulfate sodium

Inactive ingredients: microcrystalline cellulose, magnesium stearate, gelatin, pharmaceutical glaze (modified) in SD-45, synthetic black iron oxide, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, FD&C Blue No. 1 aluminum lake, D&C Yellow No. 10 aluminum lake, n-butyl alcohol, propylene glycol, SDA-3A alcohol, and titanium dioxide.
ELMIRON is a registered trademark of Teva Branded Pharmaceutical Products R&D Inc., used under license.

© 2002, 2021 Janssen Pharmaceutical Companies

Product of Germany

Manufactured for:

Janssen Pharmaceuticals, Inc.

Titusville, New Jersey 08560

For more information, go to www.ORTHOELMIRON.com or call 1-800-526-7736.
Revised: 11/2022
Document Id: ed2029cb-3288-c2f0-e053-2a95a90a8023
Set id: f0ba651e-3d8a-11df-8fbe-119855d89593
Version: 14
Effective Time: 20221110
Janssen Pharmaceuticals, Inc.