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.

You should not use Banzel if you have a severe liver disease, or a genetic heart rhythm disorder called short QT syndrome.

You should not stop taking Banzel suddenly, unless your doctor tells you to stop the medicine because of a serious side effect.

Some people have thoughts about suicide while taking seizure medication. Stay alert to changes in your mood or symptoms.

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.

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.

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

Usual Adult Dose for Lennox-Gastaut Syndrome:

Initial dose: 400 to 800 mg orally per day in 2 equally divided doses
-Titrate in 400 to 800 mg increments every other day until a maximum daily dose of 3200 mg/day is reached
Maintenance dose: 1600 mg orally twice a day

Comments:
-It is not known if doses lower than 3200 mg/day are effective.
-For patients concomitantly receiving valproate, initial doses should be lower; see dose adjustments section.

Use: For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome.

Usual Pediatric Dose for Lennox-Gastaut Syndrome:

1 year of age or older:
Initial dose: 10 mg/kg/day orally in 2 equally divided doses
-Titrate in 10 mg/kg increments every other day to a target dose of 45 mg/kg/day
Maintenance dose: 45 mg/kg orally per day in 2 equally divided doses
Maximum dose: 3200 mg/day

Comments:
-It is not known if doses lower than 45 mg/kg (not to exceed 3200 mg/day) are effective.
-For patients concomitantly receiving valproate, initial doses should be lower; see dose adjustments section.

Use: For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older

You should not use Banzel if you are allergic to rufinamide, or if you have:

• a genetic heart rhythm disorder called short QT syndrome; or

• severe liver disease.

To make sure Banzel is safe for you, tell your doctor if you have ever had:

• heart disease;

• liver disease;

• kidney disease (or if you are on dialysis); or

• depression, mental illness, or suicidal thoughts or actions.

Some people have thoughts about suicide while taking Banzel. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking seizure medication during pregnancy without your doctor's advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of rufinamide on the baby.

Banzel can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using rufinamide, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Banzel should not be given to a child younger than 1 year old.

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.

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

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Drinking alcohol can increase certain side effects of rufinamide.

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.

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.