Rufinamide (roo-FIN-a-mide)

Treats seizures in patients who have Lennox-Gastaut syndrome.

Brand Name(s):

Banzel

When This Medicine Should Not Be Used:

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 you take each dose.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: 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.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the oral liquid upright. Use the liquid within 90 days after you open the bottle for the first time. Throw away any unused medicine.

Drugs and Foods to Avoid:

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

• Some medicines can affect how rufinamide works. Tell your doctor if you are using any of the following:
  • Carbamazepine, lamotrigine, phenobarbital, phenytoin, primidone, valproate
  • Birth control pills
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, heart rhythm problems, a history of depression or mental health problems, or are on dialysis.
• This medicine may cause the following problems:
  • Changes in heart rhythm
  • Multi-organ hypersensitivity reaction, which can damage organs such as liver, kidneys, or heart
• This medicine may increase depression or thoughts of suicide. Tell your doctor right away if you start to feel more depressed or think about hurting yourself.
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely. Your seizures may return or happen more often if you stop this medicine suddenly.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Depression, unusual moods or behavior, thoughts of hurting yourself
• Fast, pounding, or uneven heartbeat, fainting
• Fever, chills, cough, sore throat, unusual bleeding or bruising
• Problems with walking or balance, tremors, weakness
• Rash with fever, swollen glands in your neck, armpit, or groin

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

• Changes in vision, headache
• Mild nausea or vomiting
• Sleepiness, 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