Pentosan Polysulfate Sodium, Oral

________________________________________________________________________

KEY POINTS

• This medicine is taken by mouth to treat bladder pain caused by interstitial cystitis. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause you to bleed more easily or bleed longer, or cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: anticoagulant (medicine that reduces the chance of blood clots forming); analgesic

Generic and brand names: pentosan polysulfate sodium, oral; Elmiron

What is this medicine used for?

This medicine is taken by mouth to treat bladder pain caused by interstitial cystitis (inflamed bladder).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine, especially heparin
• A bleeding or blood clotting disorder
• An aneurysm or stroke
• Colon polyps or diverticulitis
• Liver or spleen problems
• Ulcers

Also tell your healthcare provider if you are taking a medicine that reduces the chance of blood clots forming such as warfarin (Coumadin) or heparin.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes.

Check with your healthcare provider before using this medicine in children under age 16.

Take this medicine on an empty stomach (1 hour before or 2 hours after a meal) with a full glass of water. Your healthcare provider will review your condition after 3 months.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: nosebleed; blood in the urine; black, bloody or tarry bowel movements, severe stomach pain or diarrhea.

What should I watch out for?

This medicine may cause you to bleed more easily or bleed longer. Contact your healthcare provider if you have any unusual bruising or bleeding.

You may need to have blood tests regularly to see how this medicine affects you. Keep all appointments.

This medicine may cause you to lose hair on one spot of your scalp. The hair will grow back after the treatment is over.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Severe stomach pain or diarrhea, unusual bruising or bleeding, bloody or black bowel movements, blood in your urine, coughing or vomiting blood, unusual tiredness or weakness, severe dizziness or fainting.

Other: Nausea, diarrhea, headache, hair loss, mild dizziness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Aspirin and other salicylates
• Medicines to treat or prevent blood clots such as clopidogrel (Plavix), dalteparin (Fragmin), dipyridamole (Persantine), enoxaparin (Lovenox), heparin, prasugrel (Effient), ticagrelor (Brilinta), and warfarin (Coumadin)
• Natural remedies such as garlic, ginger, ginkgo, green tea, and horse chestnut
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.