Medication Guide App

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

Banzel is used for:

Treating seizures in certain patients with Lennox-Gastaut syndrome. It should be used along with other medicine(s).

Banzel is an anticonvulsant. Exactly how it works is not known, but it may work by slowing abnormal nerve impulses in the brain.

Do NOT use Banzel if:

  • you are allergic to any ingredient in Banzel
  • you have or a family member has a history of certain heart problems (eg, short QT syndrome)
  • you have severe liver problems

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Banzel:

Some medical conditions may interact with Banzel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of heart problems
  • if you have a history of mental or mood problems (eg, depression), suicidal thoughts or actions, or alcohol abuse or dependence
  • if you are on dialysis
  • if you have liver problems

Some MEDICINES MAY INTERACT with Banzel. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Divalproex or valproic acid because they may increase the risk of Banzel's side effects
  • Carbamazepine, phenobarbital, phenytoin, or primidone because they may decrease Banzel's effectiveness
  • Phenobarbital or phenytoin because the risk of their side effects may be increased by Banzel
  • Carbamazepine, lamotrigine, oral contraceptives (eg, birth control pills), or triazolam because their effectiveness may be decreased by Banzel
  • Medicines that may cause a certain type of irregular heartbeat (shortened QT interval). Ask your doctor if you are unsure if any of your medicines might shorten the QT interval

This may not be a complete list of all interactions that may occur. Ask your health care provider if Banzel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Banzel:

Use Banzel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Banzel comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Banzel refilled.
  • Take Banzel by mouth with food.
  • Shake well before each use.
  • Use the bottle adapter and dosing syringe that come with Banzel to measure your dose. Be sure you understand how to use the adapter and syringe. Ask your pharmacist for help if you are unsure of how to measure your dose.
  • Do not suddenly stop taking Banzel or your other seizure medicines. You may have an increased risk of seizures. If you need to stop Banzel or add a new medicine, your doctor will gradually lower your dose.
  • Taking Banzel at the same time each day will help you remember to take it.
  • Take Banzel on a regular schedule to get the most benefit from it.
  • Continue to take Banzel even if you feel well. Do not miss any doses.
  • If you miss a dose of Banzel, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Banzel.

Important safety information:

  • Banzel may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Banzel with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Banzel; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do NOT take more than the recommended dose without checking with your doctor.
  • Banzel may increase the risk of suicidal thoughts or actions in some patients. Watch patients who take Banzel closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
  • Contact your health care provider if your seizures become worse, if you have a new type of seizure, or if you develop a rash associated with a fever.
  • Tell your doctor or dentist that you take Banzel before you receive any medical or dental care, emergency care, or surgery.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are taking Banzel. To prevent pregnancy, use an extra form of birth control (eg, condoms).
  • Lab tests, including complete blood cell counts and liver function, may be performed while you use Banzel. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Banzel should be used with extreme caution in CHILDREN younger than 4 years; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Banzel while you are pregnant. Banzel is found in breast milk. Do not breast-feed while taking Banzel.

Possible side effects of Banzel:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; headache; nausea; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue); appetite changes; blood in the urine; change in the amount of urine produced; decreased coordination or trouble walking; fever, chills, or sore throat; irregular heartbeat; new or worsening behavior, or mental or mood changes (eg, aggression, agitation, anger, anxiety, depression, irritability, mania, panic attacks, restlessness); new or worsening seizures; severe muscle pain; severe or persistent dizziness, drowsiness, tiredness, or weakness; suicidal thoughts or attempts; swollen lymph nodes; tremor; trouble sleeping; unusual bruising or bleeding; vision changes (eg, blurred vision, double vision); yellowing of the skin or eyes, dark urine, or pale stools.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Banzel:

Store Banzel at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store upright with the cap securely in place. The cap fits properly when the adapter is in place. Store away from heat, moisture, and light. Do not store in the bathroom. Throw away any remaining medicine 90 days after the bottle is first opened. Keep Banzel out of the reach of children and away from pets.

General information:

  • If you have any questions about Banzel, please talk with your doctor, pharmacist, or other health care provider.
  • Banzel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Banzel or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Banzel. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Banzel. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Banzel.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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