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The following safety and warning information is essential for the safe use of this medication. Please read carefully and consult your healthcare provider with any questions or concerns.

• Gastrointestinal Risks: In rare cases, Symproic (naldemedine) users have experienced serious stomach or intestinal issues, such as inflammation or tears in the gut wall, potentially requiring hospitalization. Before starting Symproic, inform your prescriber if you have a history of bowel or intestinal problems. Seek immediate medical attention if you experience severe or persistent stomach pain, worsening pain, chills, or fever. Increased risk is associated with conditions such as gastrointestinal cancer, recent gastrointestinal surgery, or inflammation-related disorders like Crohn's disease, diverticulitis, or colitis.

• Opioid Withdrawal Symptoms: Although uncommon, some individuals taking Symproic have reported withdrawal symptoms including sweating, chills, diarrhea, stomach pain, anxiety, and irritability. There may also be a reduction in pain relief from opioid medications. Individuals with conditions affecting the blood-brain barrier, such as a stroke or brain injury, are at a heightened risk. Contact your healthcare provider if you notice withdrawal symptoms or if your opioid medication seems less effective.

• Contraindications: Do not use this medication if you have a known or suspected blockage in the gut, as this can lead to serious health complications. If this applies to you, consult your healthcare provider for guidance.

By adhering to these warnings and consulting with your healthcare provider as needed, you can help ensure the safe use of this medication.

When taking this medication, some people may experience mild side effects such as stomach pain, diarrhea, or nausea. These are generally not serious, but if they persist or worsen, it's a good idea to consult your healthcare provider for advice and reassurance.

There are also less common side effects that some individuals might encounter, including vomiting and gut inflammation. While these are not typical, monitoring how you feel and discussing any concerns with your healthcare provider is important to ensure your comfort and safety.

More severe side effects, though rare, demand immediate medical attention. These include a potential tear in the stomach or intestinal wall, characterized by severe and persistent stomach pain, fever, or fainting. Additionally, symptoms of opioid withdrawal, such as mood changes, anxiety, and unusual yawning, require prompt medical evaluation. A very serious allergic reaction is also possible, presenting with rash, swelling of the face or throat, or trouble breathing. If you experience any of these severe symptoms, it is crucial to seek urgent medical care to address these issues promptly and effectively.