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Rufinamide (By mouth)

Rufinamide (roo-FIN-a-mide)

Treats seizures in patients who have Lennox-Gastaut syndrome (LGS).

Brand Name(s):

Banzel

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

You should not use this medicine if you have had an allergic reaction to rufinamide, or if you have a heart rhythm problem called Familial Short QT syndrome.

How to Use This Medicine:

Liquid, Tablet

  • Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
  • It is best to take this medicine with food or milk. The tablets may be taken whole, broken in half, or crushed if needed.
  • Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup. Shake the bottle well just before taking each dose.
  • This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

If a dose is missed:

  • Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the oral liquid in an upright position. Use the liquid within 90 days after opening the bottle for the first time. Throw away any unused liquid.
  • Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Make sure your doctor knows if you are also using other medicines to treat seizures (such as carbamazepine, lamotrigine, phenobarbital, phenytoin, primidone, valproate, Carbatrol®, Depakene®, Dilantin®, Lamictal®, or Tegretol®), birth control pills (such as Aygestin®, Brevicon®, Estinyl®, Norinyl®, Ortho-Novum®, Ovcon®), or triazolam (Halcion®).
  • Tell your doctor if you drink alcohol or if you are using any medicine that makes you sleepy, such as allergy medicine or narcotic pain medicine.
  • Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

  • Make sure your doctor knows if you are pregnant or breastfeeding, or if you have liver disease, heart rhythm problems (such as a shortened QT interval), or severe kidney disease that requires dialysis.
  • If you or your child develop any unusual or strange thoughts and behavior while taking this medicine, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink too much alcohol. Other changes might be confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.
  • This medicine may make you dizzy, drowsy, clumsy, or less alert. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
  • This medicine may cause serious allergic reactions that may affect several parts of the body, such as the liver or kidneys. Check with your doctor right away if you or your child have more than one of the following symptoms: fever, dark-colored urine, headache, rash, itching, extra fluid around the face, stomach pain, unusual tiredness, or yellowing of the skin or the whites of your eyes.
  • Birth control pills may not work as well while you are using this medicine. To keep from getting pregnant, use another form of birth control together with your birth control pills. Other forms include condoms, diaphragms, or contraceptive foams or jellies.
  • Tell your doctor if you become pregnant while taking this medicine. Your doctor may want you to join the North American Antiepileptic Drug Pregnancy Registry. The registry is used by pregnant patients who are taking this medicine.
  • Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
  • Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Confusion, depression, unusual behavior, or thoughts of hurting yourself.
  • Dark-colored urine or pale stools.
  • Fast or pounding heartbeat.
  • Fever, chills, cough, sore throat, and body aches.
  • Lightheadedness, dizziness, or fainting.
  • Nausea, vomiting, loss of appetite, or pain in your upper stomach.
  • Problems with walking or balance control.
  • Rash or itching skin.
  • Sleepiness or unusual drowsiness.
  • Tremors or muscle cramps.
  • Unsteadiness (having a hard time standing up).
  • Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

  • Blurred vision or headache.
  • Feeling of constant movement of self or surroundings.
  • Problems with hearing.
  • Stuffy or runny nose.
  • Tiredness.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088


Last Updated: 8/4/2014


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