BANZEL- rufinamide tablet, film coated 
BANZEL- rufinamide suspension 
Eisai Inc.

----------

Medication Guide
BANZEL (ban-‘zel)
[rufinamide]
Tablets and Oral Suspension

Read this Medication Guide before you start taking BANZEL and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. 

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

Do not stop taking BANZEL without first talking to your healthcare provider.

Stopping BANZEL suddenly can cause serious problems.

BANZEL can cause serious side effects, including:

1. Like other antiepileptic drugs, BANZEL may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

How can I watch for early symptoms of suicidal thoughts and actions?

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop BANZEL without first talking to a healthcare provider.  

2. BANZEL may cause you to feel sleepy, tired, weak, dizzy, or have problems with coordination and walking.

What is BANZEL?

BANZEL is a prescription medicine used with other medicines to treat seizures associated with Lennox-Gastaut Syndrome (LGS) in adults and pediatric patients 1 year of age and older.

It is not known if BANZEL is safe and effective in the treatment of Lennox-Gastaut Syndrome in pediatric patients under 1 year of age.

Who should not take BANZEL?

Do not take BANZEL if you have a genetic condition called familial short QT syndrome, a problem that affects the electrical system of the heart.

What should I tell my healthcare provider before taking BANZEL?

Before you take BANZEL, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Taking BANZEL with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine.

How should I take BANZEL?

What should I avoid while taking BANZEL?

What are the possible side effects of BANZEL?

See “What is the most important information I should know about BANZEL?”

BANZEL may cause serious side effects including:

Call your healthcare provider right away if you have any of the following. Symptoms may include:

Call your healthcare provider right away if you have any of the symptoms listed above.

The most common side effects of BANZEL include:

Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all of the possible side effects of BANZEL. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store BANZEL?

Tablets

Oral Suspension

Keep BANZEL and all medicines out of the reach of children.

General Information about the safe and effective use of BANZEL

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BANZEL for a condition for which it was not prescribed. Do not give BANZEL to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about BANZEL. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about BANZEL that is written for health professionals.

For more information, go to www.banzel.com or call 1-888-274-2378.

What are the ingredients in BANZEL?

Tablets

Active ingredient: rufinamide

Inactive ingredients: colloidal silicon dioxide, corn starch crosscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulphate, iron oxide red, polyethylene glycol, talc, and titanium dioxide.

Oral Suspension

Active ingredient: rufinamide

Inactive ingredients: microcrystalline cellulose and carboxymethylcellulose sodium, hydroxyethylcellulose, anhydrous citric acid, simethicone emulsion 30%, poloxamer 188, methylparaben, propylparaben, propylene glycol, potassium sorbate, noncrystallizing sorbitol solution 70%, orange flavor.

The oral suspension does not contain lactose or gluten and is dye-free. The oral suspension does contain carbohydrates.

Distributed by Eisai Inc., Nutley, NJ 07110

Revised: 12/2021

This Medication Guide has been approved by the U.S. Food and Drug Administration.

© 2008-2021 Eisai Inc.

Revised: 12/2021
Eisai Inc.