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The following safety information outlines important warnings related to the use of Elmiron (pentosan). Please read them thoroughly and discuss any concerns with your healthcare provider.

• Eye Health Concerns (Pigmentary Maculopathy): Elmiron (pentosan) may lead to changes in the retina, known as pigmentary maculopathy, potentially affecting vision. These changes can be permanent even after discontinuation of the drug. If you notice difficulty reading, blurred vision, or slow adaptation to low light, contact your doctor immediately. Regular eye examinations are advised during treatment to detect any early changes.

• Increased Bleeding Risk: Elmiron (pentosan) can increase the risk of bleeding, especially if you are also taking blood thinners, high doses of aspirin, or NSAIDs. Contact your healthcare provider promptly if you experience blood in your stool, frequent nosebleeds, or easy bruising.

• Liver Function Concerns: This medication may cause abnormal liver test results. Although this does not always indicate liver issues, inform your healthcare provider if you have a history of liver conditions, as this may elevate your risk of side effects.

Contraindications:

• Do not use Elmiron (pentosan) if you have an allergy or sensitivity to it or heparin products. If these conditions apply to you, consult your healthcare provider before starting this medication.

When taking this medication, you may experience some common side effects that are generally mild, such as hair loss, diarrhea, nausea, headache, rash, stomach pain, and upset stomach. These symptoms often resolve on their own, but if they persist or worsen, it's advisable to consult your healthcare provider. Less commonly, you might notice symptoms such as dizziness, gas, constipation, loss of appetite, sore throat, stuffy nose, itchiness, or hives. While these are not typically serious, you should still inform your healthcare provider if they occur.

There are also some side effects that, although rare, can be more serious and require prompt medical attention. These include unusual bruising or bleeding (like blood in stool), vision changes such as blurred vision or changes in the retina (pigmentary maculopathy), eye pain, mental or mood changes, heartburn, discomfort when swallowing, tiredness, fast or pounding heartbeat, and shortness of breath. If you experience any of these, seek medical care immediately. Lastly, although a very serious allergic reaction is rare, symptoms such as rash, itching or swelling especially of the face, tongue, or throat, severe dizziness, or trouble breathing necessitate immediate emergency assistance. Always communicate with your healthcare provider about any unexpected effects to ensure your safety and well-being.

When using Elmiron (pentosan), it's important to be aware of potential interactions with other medications or supplements. Some drugs, particularly blood thinners like Warfarin, heparin, Rivaroxaban, and Clopidogrel, may interact with Elmiron. Additionally, Mifepristone and certain pain relievers such as NSAIDs (Aspirin, Ibuprofen, Naproxen, Ketorolac) can increase side effects when used together with Elmiron. If your healthcare provider advises you to take low-dose aspirin (81-162 mg daily) for heart attack or stroke prevention, continue its use unless instructed otherwise. Consult your doctor or pharmacist for specific guidance.

Elmiron may also interfere with lab tests, such as prothrombin time/INR and factor Xa levels, possibly leading to inaccurate results. It's crucial to inform laboratory personnel and all your healthcare providers that you are using this medication.

Other medications that might require dose adjustments or careful monitoring when taken with Elmiron include various anticoagulants, anti-inflammatory drugs, and herbal supplements like chamomile and St John's Wort. Always discuss your current medications and supplements with your doctor to ensure safe and effective treatment.