BANZEL (Rufinamide)

What is this medication?

Banzel is a seizure medication, also called an anti-epileptic or anticonvulsant.
Banzel is used together with other medicines to treat seizures caused by Lennox-Gastaut syndrome, a severe form of childhood epilepsy that also causes developmental and behavior problems.
Banzel is for use in adults and children who are at least 1 year old.

How should I take this medication?

Take Banzel exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

• Take Banzel with food.

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

• Shake the oral suspension (liquid) well just before you measure a dose.

• Measure the liquid using the dosing syringe and bottle adapter provided with this medicine. Insert the adapter into the bottle and snap it into place. Insert the syringe into the adapter and turn the bottle upside down. To measure your dose, pull the plunger to the correct number of milliliters marked on the side of the syringe. Rinse the syringe with water after each use.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Call your doctor if your seizures get worse or you have them more often while taking Banzel.

You should not stop using Banzel suddenly, unless your doctor tells you to stop the medicine because of a serious side effect. Stopping suddenly may cause increased seizures. Follow your doctor's instructions very carefully.

In case of emergency, wear or carry medical identification to let others know you use rufinamide.

What if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Get your prescription refilled before you run out of medicine completely.

How should I store this medication?

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. Do not try to remove the bottle adapter once it is in place. Throw away Banzel liquid 90 days after you first opened the bottle, even if there is medicine left inside.

What are the possible side effects of using this medication?

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

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

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.

Call your doctor at once if you have:

• loss of balance or coordination;
• trouble walking; or
• worsening or increased seizures.

Common Banzel side effects may include:

• headache;
• dizziness, drowsiness;
• nausea; or
• feeling tired.

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 Banzel?

Using Banzel with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• valproic acid (Depakene, Stavzor).

This list is not complete. Other drugs may interact with rufinamide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.