Elmiron contains the active ingredient pentosan polysulfate sodium, which is a heparin-like compound. This drug is available in hard gelatin capsule form, with each capsule containing 100 mg of pentosan polysulfate sodium. It is administered orally. Key inactive ingredients include microcrystalline cellulose and magnesium stearate, along with several colorants and other additives.

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Take this medication on an empty stomach, at least 1 hour before and 2 hours after food. Do not take with food. Keep taking it unless your care team tells you to stop. Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 16 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date. To get rid of medications that are no longer needed or have expired: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding -Change in vision -Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Diarrhea -Dizziness -Hair loss -Headache -Nausea -Stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Bleeding disorders -Bleeding in the brain -Eye disease, vision problems -History of low blood counts caused by a medication -Liver disease -Stomach or intestine problems -Take medications that treat or prevent blood clots -An unusual or allergic reaction to pentosan, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

-Aspirin, especially in higher doses -Certain medications that prevent and treat blood clots, such as warfarin, heparin, enoxaparin, dalteparin, apixaban, dabigatran, rivaroxaban -Clopidogrel -Dipyridamole -NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen -Ticlopidine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. You may need blood work done while you are taking this medication. Your condition will be monitored carefully while you are receiving this medication. It is important not to miss any appointments. This medication can cause serious eye damage. Tell your care team right away if you have changes in your eyesight. Within 6 months of starting this medication, you should have a retinal eye exam. If you take this medication long term, you will need regular eye exams. This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding. Avoid sports and activities that might cause injury while you are using this medication. Severe falls or injuries can cause unseen bleeding. Be careful when using sharp tools or knives. Consider using an electric razor. Take special care brushing or flossing your teeth. Report any injuries, bruising, or red spots on the skin to your care team. If you are going to need surgery or a procedure, tell your care team that you are using this medication.