Side Effects

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

Remember that this medication has been prescribed because your doctor 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 you have any serious side effects, including: unusual bruising/bleeding (such as blood in stool), vision changes (such as blurred vision), eye pain, mental/mood changes, heartburn, discomfort when swallowing, tiredness, fast/pounding heartbeat, shortness of breath.

A very serious allergic reaction to this drug is rare. However, get medical help right away 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.

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 may increase the risk of bruising/bleeding (such as bleeding from the nose/gums).

How to use Elmiron

Read the Medication Guide provided by 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 as directed by your doctor, usually 3 times daily.

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 or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

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

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 (such as hemophilia, thrombocytopenia), blood vessel disorders (such as aneurysm), eye disorders, liver disease, spleen disorders, stomach/intestinal disorders (such as stomach ulcers, polyps, diverticula).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug include: “blood thinners” (such as warfarin, heparin, tenecteplase, abciximab, clopidogrel, ticlopidine), mifepristone, 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 81-162 milligrams a day). Ask your doctor or pharmacist for more details.

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

Do not share this medication with others.

Lab and/or medical tests (such as eye exams, liver function) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

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.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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.