Banzel

Generic Name: rufinamide (roo FIN a mide)Brand Names: Banzel

What is rufinamide?

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 is the most important information I should know about rufinamide?

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.

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

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. 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 is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. 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. Rufinamide may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Rufinamide is not for use in children younger than 4 years old.

How should I take rufinamide?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

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

Take rufinamide with food.

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.

Carry an ID card or wear a medical alert bracelet stating that you have seizures, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication.

It is important to use rufinamide regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

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

See also: Banzel dosage in more detail

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a rufinamide overdose are not known.

What should I avoid while taking rufinamide?

Avoid drinking alcohol. It can increase some of the side effects of rufinamide. Rufinamide can cause side effects that may impair your vision or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Rufinamide side effects

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 other drugs will affect rufinamide?

Before taking rufinamide, tell your doctor about all other seizure medications you use, especially:

• carbamazepine (Carbatrol, Tegretol);

• phenobarbital (Luminal, Solfoton);

• phenytoin (Dilantin); or

• valproic acid (Depakene).

This list is not complete and there may be other drugs that can interact with rufinamide. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using 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.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.02. Revision Date: 4/12/2009 4:46:21 PM.