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Your doctor is your first and best source of information about your condition and treatment with NUEDEXTA. Talk to your doctor about the risks and benefits of taking NUEDEXTA, and be sure to ask any questions you have about how to use NUEDEXTA safely. Further important information is available at 1-855-4NUEDEX (468-3339).
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Patient Information Booklet
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This booklet is designed to provide information about the use of NUEDEXTA. This information does not take the place of talking with your doctor about your health problem or treatment. We encourage you to read it and share it with others. |
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Important Safety Information
NUEDEXTA® (dextromethorphan hydrobromide and quinidine sulfate) capsules are approved for the treatment of pseudobulbar affect (PBA). PBA is a medical condition that can occur in patients with certain underlying neurologic conditions and causes involuntary, sudden, and frequent episodes of laughing and/or crying.
NUEDEXTA can interact with other medications, causing significant changes in how those medications or NUEDEXTA may affect you. Tell your doctor about all medications and supplements you are taking before taking NUEDEXTA. While taking NUEDEXTA, do not start any new medications without first talking with your doctor. Ask your doctor what medications you cannot use with NUEDEXTA.
An allergic reaction to NUEDEXTA could occur. Seek medical attention immediately if you develop symptoms of an allergic reaction such as swelling of the throat and tongue, difficulty breathing, abnormal heart rate or rhythm (arrhythmia), dizziness, fever, rash, or hives after taking NUEDEXTA.
NUEDEXTA may cause serious side effects, including changes in heart rhythm. Tell your doctor if you or a family member currently have or have ever had any heart disease or problems. If you have certain heart problems or if currently taking certain other medications, NUEDEXTA may not be appropriate for you, or your doctor may want to monitor your heart rate when you start NUEDEXTA.
NUEDEXTA may cause dizziness. Precautions to reduce the risk of falls should be taken.
The most common side effects of NUEDEXTA include diarrhea, dizziness, cough, vomiting, weakness, swelling of feet and ankles, urinary tract infection, flu, elevated liver enzymes, and flatulence. Tell your doctor immediately if you feel faint or lose consciousness after taking NUEDEXTA. Tell your doctor about any side effect that bothers you or does not go away.
Take NUEDEXTA exactly as your doctor tells you. If you forget to take 1 or more capsules, do not take a double dose. Take your next dose of NUEDEXTA in the prescribed amount at the usual time. Do not take more than 2 capsules in a 24-hour period. Make sure that approximately 12 hours passes between doses.
Do not share NUEDEXTA or give it to others, even if they have the same symptoms as you. Tell your doctor if your PBA outbursts continue or get worse. Keep NUEDEXTA and all medications out of reach of children and pets.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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