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rufinamide

Pronunciation: roo FIN a mide

Brand: Banzel

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

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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."

Before taking rufinamide, tell your doctor if you have heart disease, liver disease, kidney disease (or if you are on dialysis), or a history of depression, mental illness, or suicidal thoughts or actions.

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It is not known whether rufinamide will harm an unborn baby, but having a seizure during pregnancy could harm both the mother and the baby. Tell your doctor right away if you become pregnant while taking rufinamide for seizures. Do not start or stop taking rufinamide during pregnancy without your doctor's advice.

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.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, agitated, hostile, aggressive, restless, irritable, hyperactive, talkative, or have thoughts about suicide or hurting yourself.

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Do not stop using rufinamide without first talking to your doctor, even if you feel fine. You may have increased seizures if you stop using rufinamide suddenly. You may 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.

What is rufinamide?

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

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

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

What should I discuss with my healthcare provider before taking rufinamide?

Multum donot

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."

To make sure you can safely take rufinamide, tell your doctor if you have any of these other conditions:

  • heart disease;
  • liver disease;
  • kidney disease (or if you are on dialysis); or
  • a history of depression, mental illness, or suicidal thoughts or actions.

You may have thoughts about suicide while taking this medication. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several months of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

FDA pregnancy category C. It is not known whether rufinamide will harm an unborn baby, but having a seizure during pregnancy could harm both mother and baby. Do not start taking rufinamide without telling your doctor if you are pregnant or planning to become pregnant. If you become pregnant while taking rufinamide, do not stop taking the medicine without your doctor's advice.

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Seizure control is very important during pregnancy. The benefit of preventing seizures may outweigh any risks posed by taking rufinamide. Follow your doctor's instructions about taking rufinamide while you are pregnant.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of rufinamide on the baby.

Rufinamide can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking rufinamide.

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Rufinamide can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using rufinamide.

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Rufinamide should not be given to a child younger than 4 years old.

How should I take rufinamide?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

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Take rufinamide with food.

The rufinamide tablet may be swallowed whole, crushed, or cut in half.

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Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. Do not use a regular table spoon to measure the liquid. If you do not have a dosing syringe or dose-measuring device, ask your pharmacist for one.

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

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Wear a medical alert tag or carry an ID card stating that you take rufinamide. Any medical care provider who treats you should know that you take seizure medication.

Use rufinamide regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Contact your doctor if your seizures get worse or you have them more often while taking rufinamide.

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Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Store the liquid medicine in an upright position. Throw away any unused liquid after 90 days.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking rufinamide?

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Drinking alcohol can increase certain side effects of rufinamide.

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This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

What are the possible side effects of rufinamide?

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, agitated, hostile, aggressive, restless, irritable, hyperactive, talkative, or have thoughts about suicide or hurting yourself.

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Stop using rufinamide and call your doctor at once if you have any of these serious side effects:

  • fever, swollen glands, body aches, flu symptoms, feeling very weak or tired;
  • painful sores in or around your eyes or mouth, sore throat, trouble swallowing;
  • loss of balance or coordination, trouble walking;
  • skin rash, easy bruising or bleeding, severe tingling, numbness, pain, severe muscle pain or weakness;
  • upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
  • chest pain, irregular heart rhythm, feeling short of breath;
  • confusion, nausea and vomiting, swelling, rapid weight gain;
  • lower back pain, bloody urine, urinating less than usual;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • new or worsening cough with fever, trouble breathing; or
  • worsening of seizures.

Less serious side effects may include:

  • headache;
  • dizziness, drowsiness;
  • increased or decreased appetite;
  • nausea, vomiting;
  • stuffy nose, sinus pain; or
  • blurred vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect rufinamide?

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Before using rufinamide, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for depression or anxiety). They can add to sleepiness caused by rufinamide.

Tell your doctor about all other seizure medications you use, especially:

  • carbamazepine (Carbatrol, Equetro, Tegretol);
  • phenobarbital (Luminal, Solfoton);
  • phenytoin (Dilantin);
  • primidone (Mysoline); or
  • valproic acid (Depakene, Stavzor).

This list is not complete and other drugs may interact with rufinamide. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about rufinamide.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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