• NUEDEXTA® is approved for the treatment of Pseudobulbar Affect (PBA). PBA is a medical condition that causes involuntary, sudden, and frequent episodes of crying and/or laughing in people living with certain neurologic conditions or brain injury. PBA episodes are typically exaggerated or don’t match how the person feels. PBA is distinct and different from other types of emotional changes caused by neurologic disease or injury. • NUEDEXTA is only available by prescription. DO NOT TAKE NUEDEXTA IF YOU • Are taking other drugs that contain quinidine, quinine, or mefloquine. • Have a history of allergic reactions or intolerance (including hepatitis, low blood cell count, or lupus-like syndrome) to quinidine, quinine, or mefloquine. • Have ever been allergic to dextromethorphan (commonly found in some cough medicines). • Are taking, or have taken, drugs called monoamine oxidase inhibitors (MAOIS). MAOIS cannot be taken within 14 days before or after taking NUEDEXTA. • Have had heart disease or have a family history of heart rhythm problems. • Are taking drugs such as thioridazine and pimozide that interact with NUEDEXTA and cause changes in heart rhythm. If you have certain heart conditions or are taking certain medicines, your doctor may test your heart rhythm (heartbeats) before you start NUEDEXTA. NUEDEXTA MAY CAUSE SERIOUS SIDE EFFECTS • Stop NUEDEXTA if these side effects occur: Symptoms including lightheadedness, chills, fever, nausea, or vomiting may be a sign of an allergic reaction, or thrombocytopenia which if left untreated can be fatal. Hepatitis has been seen in patients taking quinidine, an ingredient in NUEDEXTA. Abnormal heart rhythm. Stop NUEDEXTA and tell your doctor immediately as it may be a sign of Torsades de Pointes. • In some cases NUEDEXTA can interact with antidepressants causing confusion, high blood pressure, fever, restlessness, sweating, and shivering. Tell your doctor if you experience any of these side effects. • Tell your doctor if you’ve ever been diagnosed with myasthenia gravis. If so, NUEDEXTA may not be right for you.
POSSIBLE COMMON SIDE EFFECTS OF NUEDEXTA
The most common side effects in patients taking NUEDEXTA were diarrhea, dizziness, cough, vomiting, weakness and swelling of feet and ankles. • If you are unsteady on your feet or if you have fallen before, be careful while taking NUEDEXTA to avoid falling. • This is not a complete list of side effects. • Tell your doctor if you have any side effect that bothers you or does not go away.