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BANZEL®
(rufinamide)"Bottles not actual size"
http://www.banzel.com
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BANZEL® is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children 4 years and older and adults.
LGS is a rare form of epilepsy in which patients experience seizures of multiple types. LGS accounts for 1 to 4 percent of all childhood epilepsy cases.
For more information about Banzel®, including full prescribing information and the medication guide, visit www.banzel.com or call 1-888-274-2378. If you are a U.S. healthcare professional you may also search for more information at www.eisaimedicalinformation.com.
Important Safety Information
There are risks associated with the use of BANZEL that you should know about. We encourage you to talk to your healthcare provider about these risks.
Patients with a history of Familial Short QT syndrome should not be treated with BANZEL. Talk to your healthcare provider if you are unsure if this affects you or your loved one. BANZEL has been shown to reduce the QT interval. Caution should be used when taking other drugs that shorten the QT interval.
All medications to treat seizures, including BANZEL, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you or your loved one experiences new or worsening symptoms of depression, unusual changes in mood or behavior, thoughts or actions about suicide or self-harm, aggression, agitation, anger, anxiety, or irritability.
Use of BANZEL has been associated with side effects such as sleepiness or feeling tired, difficulty with coordination, dizziness, and problems with walking or movement.
Alcohol, in combination with BANZEL, may increase or worsen these side effects.
Call your healthcare provider if you or your loved one experiences a rash. This can be a sign of a more serious condition, such as multi-organ hypersensitivity reaction.
You or your loved one should take BANZEL only as prescribed. Do not stop taking BANZEL without first talking to your healthcare provider. Stopping BANZEL suddenly can cause serious problems.
Tell your healthcare provider about all the medications you or your loved one takes, including prescription and non-prescription medications, vitamins, and herbal supplements. Using BANZEL with certain medications can affect each other, causing side effects.
In studies, the most commonly observed (≥10%) side effects with BANZEL vs placebo (sugar pill with no medicine in it), respectively, were headache (25% vs 20%), dizziness (17% vs 10%), feeling tired (15% vs 9%), sleepiness (13% vs 9%), and nausea (11% vs 7%). Most of these side effects were mild to moderate in severity and typically went away in a short amount of time.
Medication Guide: http://www.banzel.com/Docs/Pdf/BANZELmedicationguide.pdf
Package Insert: Banzel PI 0109.PDF
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