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Brand Names: Banzel

Generic Name: rufinamide (Pronunciation: roo FIN a mide)

• What is rufinamide (Banzel)?
• What are the possible side effects of rufinamide (Banzel)?
• What is the most important information I should know about rufinamide (Banzel)?
• What should I discuss with my healthcare provider before taking rufinamide (Banzel)?
• How should I take rufinamide (Banzel)?
• What happens if I miss a dose (Banzel)?
• What happens if I overdose (Banzel)?
• What should I avoid while taking rufinamide (Banzel)?
• What other drugs will affect rufinamide (Banzel)?
• Where can I get more information?

What is rufinamide (Banzel)?

Rufinamide is an anti-epileptic medication, also called an anticonvulsant.

Rufinamide is used in combination with other medications to treat children with Lennox-Gastaut syndrome, a severe form of childhood epilepsy that also causes developmental and behavior problems.

Rufinamide may also be used for other purposes not listed in this medication guide.

What are the possible side effects of rufinamide (Banzel)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; fever; swollen glands; painful sores in or around your eyes or mouth; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, panic, or if you feel hyperactive, talkative, restless, agitated, aggressive, angry, impulsive, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

• fever with a skin rash;
• trouble walking;
• loss of balance or coordination;
• swollen glands, pale skin, easy bruising or bleeding;
• nausea, pain in your upper stomach, jaundice (yellowing of your skin or eyes);
• severe tingling, numbness, pain, muscle weakness;
• lower back pain, bloody urine, urinating less than usual; or
• worsening of seizures.

Less serious side effects may include:

• dizziness, drowsiness, tired feeling;
• loss of balance or coordination;
• vomiting;
• increased or decreased appetite;
• stuffy nose, sore throat;
• headache; or
• blurred vision.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about rufinamide (Banzel)?

You should not use this medication if you are allergic to rufinamide, or if you have a genetic heart rhythm disorder called "Short QT syndrome."

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before taking rufinamide, tell your doctor if you have liver disease, kidney disease, or if you are on dialysis.

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Take rufinamide with food.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Do not stop taking rufinamide without first talking to your doctor, even if you feel better. You may have increased seizures if you stop taking rufinamide suddenly. You will need to use less and less before you stop the medication completely.

Contact your doctor if your seizures get worse or you have them more often while taking rufinamide.