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Elmiron is used for:

Relieving bladder pain or discomfort due to bladder inflammation.

Elmiron is an interstitial cystitis agent. The exact way it works is unknown, but it is thought to protect the bladder wall while it heals.

Do NOT use Elmiron if:

• you are allergic to any ingredient in Elmiron

Contact your doctor or health care provider right away if any of these apply to you.

Before using Elmiron :

Some medical conditions may interact with Elmiron . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have or have a history of a bleeding disorder due to low platelet levels, bleeding in the brain, hemophilia, stomach ulcers, intestinal polyps, or diverticulitis, or if you are taking blood thinners (eg, warfarin, aspirin, heparin)
• if you have liver problems or blood-clotting problems, or you are scheduled for surgery or another medical procedure

Some MEDICINES MAY INTERACT with Elmiron . However, no specific interactions with Elmiron are known at this time.

Ask your health care provider if Elmiron may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Elmiron :

Use Elmiron as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Elmiron . Talk to your pharmacist if you have questions about this information.
• Take Elmiron by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
• Take Elmiron with a full glass of water (8 oz/240 mL).
• Continue to use Elmiron even if you feel well. Do not miss any doses.
• If you miss a dose of Elmiron , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Elmiron .

Important safety information:

• Elmiron may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Elmiron with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Elmiron may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
• Tell your doctor or dentist that you take Elmiron before you receive any medical or dental care, emergency care, or surgery.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Elmiron while you are pregnant. It is not known if Elmiron is found in breast milk. If you are or will be breast-feeding while you use Elmiron , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Elmiron :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; hair loss; headache; nausea; stomach upset; swelling of fingers, hands, toes, or feet.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in stool; unusual bruising or bleeding.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Elmiron at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Elmiron out of the reach of children and away from pets.

General information:

• If you have any questions about Elmiron , please talk with your doctor, pharmacist, or other health care provider.
• Elmiron is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Elmiron . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.