Pentosan Polysulfate Sodium - Oral

Pronunciation: PEN-toe-san paw-lee-SULL-fate SO-dee-um

Common Brand Name(s): Elmiron

Important: How To Use This Information

This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Uses

This medication is used to treat pain/discomfort from a certain bladder disorder (interstitial cystitis). It may work by forming a layer on the bladder wall and protecting it from harmful/irritating substances in the urine. It is also a weak "blood thinner" and therefore may increase the risk of bruising/bleeding (e.g., bleeding from the nose/gums).

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start taking pentosan polysulfate sodium and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth at least 1 hour before or 2 hours after meals, usually 3 times daily or as directed by your doctor.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased.

Inform your doctor if your condition worsens or does not improve after 3 months.

Side Effects

Diarrhea, hair loss, nausea, headache, stomach upset, or abdominal pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur:

  • unusual bruising/bleeding (e.g., blood in stool)
  • mental/mood changes
  • heartburn
  • discomfort when swallowing

Tell your doctor right away if any of these rare but very serious side effects occur:

  • tiredness
  • fast/pounding heartbeat
  • signs of infection (e.g., fever, persistent sore throat)
  • shortness of breath
  • vision changes
  • eye pain
  • dark urine
  • yellowing eyes/skin
  • persistent nausea/vomiting

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking pentosan polysulfate sodium, tell your doctor or pharmacist if you are allergic to it; or to heparin or low molecular weight heparin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • bleeding disorders (e.g., hemophilia, thrombocytopenia)
  • blood vessel disorders (e.g., aneurysm)
  • liver disease
  • spleen disorders
  • stomach/intestinal disorders (e.g., stomach ulcers, polyps, diverticula)

Before having surgery, tell your doctor or dentist that you are using this medication.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medication because very serious interactions may occur:

  • mifepristone

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of:

  • "blood thinners" (e.g., warfarin, heparin, tenecteplase, abciximab, clopidogrel, ticlopidine)
  • sulfinpyrazone

Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as aspirin, ibuprofen, naproxen, ketorolac) that may increase your risk for side effects if taken together with this medication. Low-dose aspirin should be continued if prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day). Ask your doctor or pharmacist for more details.

This medication may interfere with certain laboratory tests (including prothrombin time/INR, factor Xa levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: unusual bruising/bleeding, nausea/vomiting.

Notes

Do not share this medication with others.

With prolonged treatment, medical tests (such as eye exams) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Is it an emergency?

If you or someone in your care has chest pains, difficulty breathing, or severe bleeding, it could be a life-threatening emergency. Call 9-1-1 or the local emergency number immediately.
If you are concerned about a possible poisoning or exposure to a toxic substance, call Poison Control now at 1-800-567-8911.

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