RUFINAMIDE

Do not use Rufinamide if:

• You are allergic to any ingredient in Rufinamide
• You or your family member has a certain heart problem (short QT syndrome)
• You have severe liver problems

If any of these apply to you,contact your doctor or healthcare provider right away.

Common side effects may include:

• Drowsiness
• Dizziness
• Loss of Coordination
• Trouble Walking
• Tiredness
• Headache
• Nausea
• Vomiting
• Loss of Appetite
• Blurred or double vision

Tell your doctor or pharmacist promptly if any of these effects persist or worsen.

Other side effects may include:

• Changes in Mood, Thoughts, or Behavior
• Allergic reactions such as swollen lymph nodes, rash, itching or swelling (especially of the face, tongue, throat), severe dizziness, trouble breathing

Tell your doctor right away if you experience other symptoms while or after using this drug.

Precautions

Before taking rufinamide, tell your doctor or pharmacist if:

• You are allergic to rufinamide or any other medications.
• You are taking prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products.
• You have or have ever had familial short QT syndrome (an inherited condition that causes irregular heartbeat, dizziness, fainting, or sudden death). Your doctor will probably tell you not to take rufinamide.
• You are being treated with dialysis (treatment to remove waste from the blood when the kidneys are not working well) and if you have or have ever had liver disease.
• You are pregnant, planning to become pregnant, or are breast-feeding. If you become pregnant while taking rufinamide, call your doctor.
• You are having surgery, including dental surgery.
• You are taking hormonal contraceptives (birth control pills, patches, rings, implants, and injections) because Rufinamide may decrease its effectiveness.
• You are taking alcoholic beverages. Alcohol can worsen the side effects of Rufinamide.

Rufinamide may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.

Your mental health may change in unexpected ways, and you may become suicidal (think about harming or killing yourself or plan or try to do so) while you are taking rufinamide. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms:

• Difficulty Falling Asleep or Staying Asleep
• Impulsive and Dangerous Behavior
• Panic Attacks
• Anxiety
• Agitation
• Hostility
• Mania (Frenzied, Abnormally Excited Mood)
• Talking or Thinking to Hurt Yourself or End Your Life
• Withdrawing from Friends and Family
• New or Worsening Depression

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. Tell your doctor or pharmacist all prescription and non-prescription or herbal products you are using, especially:

• Orlistat
• Valproate
• • Products that Cause Drowsiness Including Alcohol
  • Antihistamines (such as Cetirizine, Diphenhydramine)
  • Drugs for Sleep or Anxiety (such as Diazepam, Triazolam, Zolpidem)
• Muscle Relaxants
• Narcotic Pain Relievers (such as Codeine)

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy.

Call emergency hotline if someone has overdosed and has serious symptoms such as passing out or trouble breathing.