IMPORTANT SAFETY INFORMATION

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

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
- high doses of aspirin
- heparin
- anti-inflammatory medicines such as ibuprofen

Tell your healthcare provider if you are taking any of these medicines.

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 should I tell my healthcare provider before taking ELMIRON^®?

Tell your healthcare provider 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 any 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

What are the possible side effects of ELMIRON^®?

ELMIRON^® may cause serious side effects including:

changes in the retina of the eye
increased bleeding

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

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 the possible side effects of ELMIRON^®.

Call your doctor for medical advice about side effects. 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).

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 other medicines out of the reach of children.

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.

Please click here to see full Prescribing Information and read the Medication Guide.

cp-11575v5

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