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U.S. Department of Health and Human Services

Safety

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Rythmol SR (propafenone HCl) Extended-Release Capsules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2013

Summary View

 

CONTRAINDICATIONS

  • Known Brugada Syndrome
 

WARNINGS AND PRECAUTIONS

Unmasking Brugada Syndrome
  • Brugada Syndrome may be unmasked after exposure to Rythmol SR . Perform an ECG after initiation of Rythmol SR and discontinue the drug if changes are suggestive of Brugada Syndrome