Elmiron is used to treat bladder pain and discomfort caused by cystitis (bladder inflammation or irritation).

Elmiron is for use in adults and children at least 16 years old.

Elmiron may also be used for purposes not listed in this medication guide.

Taking Elmiron can make it easier for you to bleed. Call your doctor at once if you have any unusual bleeding (nosebleed, blood in your urine or stools, rectal bleeding, coughing up blood, bleeding gums).

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take Elmiron with a full glass of water. Take on an empty stomach, at least 1 hour before or 2 hours after a meal.

Swallow the delayed-release capsule whole and do not crush, chew, break, or open it.

Your doctor will need to check your progress every 3 months to help determine how long to treat you with Elmiron. You may also need blood tests and vision examinations to check for certain side effects.

If you need surgery, tell your surgeon you currently use this medicine. You may need to stop for a short time.

Store at room temperature away from moisture and heat.

You should not use Elmiron if you are allergic to it.

Tell your doctor if you have ever had:

• a bleeding or blood clotting disorder;

• eye problems (especially a problem with your retina) in you or a family member;

• an aneurysm or stroke;

• a stomach ulcer, intestinal polyps or diverticulitis; or

• liver disease.

Tell your doctor if you are pregnant or breastfeeding.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Ask a doctor or pharmacist before using any medicine that contains aspirin, ibuprofen, or similar ingredients. This includes medicine for pain, fever, swelling, or cold/flu symptoms.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Elmiron may cause serious side effects. Call your doctor at once if you have:

• nosebleeds, bleeding gums;

• blood in your urine or stools;

• rectal bleeding;

• coughing up blood;

• a light-headed feeling, like you might pass out; or

• vision problems (blurred vision, trouble reading, trouble seeing in low light).

Common side effects of Elmiron may include:

• bruising, blood in your stools;

• hair loss;

• nausea, diarrhea, upset stomach;

• headache;

• swelling, weight gain;

• dizziness;

• rash; or

• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• a blood thinner--warfarin, Coumadin, Jantoven;

• medication used to prevent blood clots--apixaban, heparin, rivaroxaban, Eliquis, Xarelto, and others; or

• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may affect Elmiron, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.