Banzel

Rufinamide is a seizure medication, also called an anti-epileptic or anticonvulsant.

Rufinamide 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. Rufinamide is for use in adults and children who are at least 1 year old.

Rufinamide may also be used for purposes not listed in this medication guide.

You should not use this medicine if you have a severe liver disease, or a genetic heart rhythm disorder called "Short QT syndrome."

Do not stop using rufinamide suddenly or you may have increased seizures.

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

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

• a genetic heart rhythm disorder called "Short QT syndrome"; or
• severe liver disease.

To make sure rufinamide is safe for you, tell your doctor if you have:

• heart disease;
• liver disease;
• kidney disease (or if you are on dialysis); or
• a history of depression, mental illness, or suicidal thoughts or actions.

You may have thoughts about suicide while taking this medicine. Your doctor should 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. This is to track the outcome of the pregnancy and to evaluate any effects of rufinamide on the baby.

Rufinamide can make hormonal birth control less effective. Use a barrier form of birth control (condom or diaphragm with spermicide). Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

Rufinamide may pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using rufinamide.

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

Contraindications

Documented hypersensitivity

Familial Short QT syndrome

Cautions

Shortens QT interval

Not recommended in severe hepatic impairment

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity, reported in patients taking antiepileptic drugs, including rufinamide; DRESS may be fatal or life-threatening; if DRESS suspected, evaluate patient immediately; discontinue therapy and initiate alternative treatment

Withdraw gradually

May impair ability to drive or perform hazardous tasks

May render hormonal contraceptives ineffective

Monitor for suicidal behavior

• (See FDA Warning on potential suicidal behavior)

Mechanism of Action

Modulates activity of sodium channels, prolonging their inactive state, which in turn limits repetitive firing of sodium-dependent action potentials and causing anticonvulsant effects

Pharmacokinetics

Bioavailability: 85%; increases by food

Half-Life: 6-10 hr

Vd: 50 L

Peak Plasma Time: 4-6 hr

Protein Bound: 34%

Enzymes induced: weak: CYP3A4

Enzymes Inhibited: weak: CYP2E1

Metabolism: hydrolysis of carboxamide group to inactive derivative

Excretion: Urine

Dialyzable: Yes (hemodialysis)

Banzel may cause serious side effects. See "Drug Precautions" section.

The most common side effects of Banzel include:

• headache
• dizziness
• tiredness
• sleepiness
• nausea
• vomiting

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.

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

• carbamazepine (Carbatrol, Equetro, Tegretol)
• divalproex (Depakote, Depakote ER)
• valproic acid (Depakene)
• phenobarbital
• phenytoin (Dilantin, Phenytek)
• hormonal birth control (pills, patches, or rings)

This is not a complete list of Banzel drug interactions. Ask your healthcare provider or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child. It is not known if Banzel can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Banzel. You and your healthcare provider will decide if you should take Banzel while you are pregnant.

• Banzel may make certain types of birth control less effective. Talk to your healthcare provider about the best birth control methods for you while you take Banzel.
• If you become pregnant while taking Banzel, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy.

Rufinamide is a seizure medication, also called an anti-epileptic or anticonvulsant.

Rufinamide 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. Rufinamide is for use in adults and children who are at least 1 year old.

Rufinamide may also be used for purposes not listed in this medication guide.

General

• Withdraw rufinamide gradually to minimize the potential for increased seizure frequency or status epilepticus in patients with seizure disorders.1 (See Dosage under Dosage and Administration.) If abrupt discontinuance is necessary, closely supervise transition to another anticonvulsant.1

• Closely monitor for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.1 2 3 4 20 (See Suicidality Risk under Cautions.)

Administration

Oral Administration

Administer orally as tablets or oral suspension twice daily in equally divided doses with food.1

Administer scored tablets whole, as half tablets, or crushed.1 21

Scored tablets may not provide the exact mg/kg dosage that has been calculated for use in children; manufacturer's recommended dosages in children are therefore designated as approximate.1 21

Shake well prior to administration of each dose.1

Administer using bottle adapter and calibrated oral dosing syringe supplied by manufacturer.1

Firmly insert bottle adapter into neck of bottle before use; allow adapter to remain in place as long as bottle is in use (up to 90 days).1

To dispense dose, insert oral dosing syringe into adapter in upright bottle, then invert bottle and withdraw appropriate dose into oral dosing syringe.1 Replace cap over bottle adapter after each use.1 Consult manufacturer's patient information (medication guide) for detailed information on administration of oral suspension.1

Dosage

Pediatric Patients

Children ≥4 years of age: Initially, approximately 10 mg/kg daily administered in 2 equally divided doses.1 Increase daily dosage in increments of approximately 10 mg/kg every other day up to a target dosage of 45 mg/kg or 3.2 g daily, whichever is lower.1 Efficacy of dosages lower than the target dosage has not been established.1

Initiate therapy at a dosage lower than 10 mg/kg daily in children receiving valproic acid.1 11 (See Specific Drugs under Interactions.)

Reduce dosage gradually if discontinuing therapy.1 In clinical trials, rufinamide dosage was tapered by approximately 25% every other day.1

Adults

Initially, 400–800 mg daily administered in 2 equally divided doses.1 Increase dosage in increments of 400–800 mg daily every other day until a maximum dosage of 3.2 g daily is reached.1 Efficacy of dosages lower than 3.2 g daily has not been established.1

Initiate therapy at a dosage lower than 400 mg daily in adults receiving valproic acid.1 11 (See Specific Drugs under Interactions.)

Reduce dosage gradually if discontinuing therapy.1 In clinical trials, rufinamide dosage was tapered by approximately 25% every other day.1

Prescribing Limits

Pediatric Patients

Children ≥4 years of age: Maximum 45 mg/kg or 3.2 g daily, whichever is less.1

Adults

Maximum 3.2 g daily.1

Special Populations

Hepatic Impairment

Not studied in patients with hepatic impairment.1 21 Do not use in patients with severe hepatic impairment.1 21 (See Hepatic Impairment under Cautions.)

Renal Impairment

No dosage adjustment necessary in patients with renal impairment (Clcr <30 mL/minute).1 11 21

Consider dosage adjustment in hemodialysis patients; hemodialysis within 3 hours after a dose may reduce drug exposure to a limited extent (by about 30%).1 11 21

Geriatric Patients

Select dosage carefully, usually initiating therapy at lower end of usual dosage range, because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.1 10

It is very important that your doctor check you or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

If you or your child develop any unusual or strange thoughts and behavior while taking this medicine, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink too much alcohol. Other changes might be confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

This medicine may cause some people to become dizzy, drowsy, lightheaded, clumsy, unsteady, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think or see well.

This medicine may cause serious allergic reactions that may affect several parts of the body (eg, liver, kidneys, or heart). Check with your doctor right away if you or your child have more than one of the following symptoms: a fever, dark-colored urine, headache, rash, itching, extra fluid around the face, stomach pain, swollen, painful, or tender lymph glands in neck, armpit, or groin, unusual tiredness, or yellow eyes or skin.

Do not suddenly stop taking this medicine without checking first with your doctor. Your seizures may return or occur more often if you stop this medicine suddenly. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

Check with your doctor if you notice any signs of fever, chills, or sore throat. These could be symptoms of an infection resulting from low white blood cell counts.

Birth control pills may not work as well while you are using this medicine. To keep from getting pregnant, use another form of birth control together with your birth control pills. Other forms include condoms, diaphragms, or contraceptive foams or jellies.

Avoid drinking alcohol while taking this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Because strategies for the management of overdose are continually evolving, it is advisable to contact a Certified Poison Control Center to determine the latest recommendations for the management of an overdose of any drug.

One overdose of 7200 mg per day Banzel was reported in an adult during the clinical trials. The overdose was associated with no major signs or symptoms, no medical intervention was required, and the patient continued in the study at the target dose.

Treatment or Management of Overdose: There is no specific antidote for overdose with Banzel. If clinically indicated, elimination of unabsorbed drug should be attempted by induction of emesis or gastric lavage. Usual precautions should be observed to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.

Hemodialysis: Standard hemodialysis procedures may result in limited clearance of rufinamide. Although there is no experience to date in treating overdose with hemodialysis, the procedure may be considered when indicated by the patient’s clinical state.

Adult and Pediatric Patients ages 4 years and older

The  effectiveness of Banzel as adjunctive treatment for the seizures associated with Lennox-Gastaut Syndrome (LGS) in adult and pediatric patients ages 4 years and older was established in a single multicenter, double-blind, placebo-controlled, randomized, parallel-group study (N=138). Male and female patients (between 4 and 30 years of age) were included if they had a diagnosis of inadequately controlled seizures associated with LGS (including both atypical absence seizures and drop attacks) and were being treated with 1 to 3 concomitant stable dose AEDs. Each patient must have had at least 90 seizures in the month prior to study entry. After completing a 4-week Baseline Phase on stable therapy, patients were randomized to have Banzel or placebo added to their ongoing therapy during the 12 -week Double-blind Phase. The Double-blind Phase consisted of 2 periods: the Titration Period (1 to 2 weeks) and the Maintenance Period (10 weeks). During the Titration Period, the dose was increased to a target dosage of approximately 45 mg/kg per day (3200 mg in adults of > 70 kg), given on a twice daily schedule. Dosage reductions were permitted during titration if problems in tolerability were encountered. Final doses at titration were to remain stable during the maintenance period. Target dosage was achieved in 88% of the Banzel-treated patients. The majority of these patients reached the target dose within 7 days, with the remaining patients achieving the target dose within 14 days.

The primary efficacy variables were:

• The percent change in total seizure frequency per 28 days;
  
• The percent change in tonic-atonic (drop attacks) seizure frequency per 28 days;
  
• Seizure severity from the Parent/Guardian Global Evaluation of the patient’s condition. This was a 7-point assessment performed at the end of the Double-blind Phase. A score of +3 indicated that the patient’s seizure severity was very much improved, a score of 0 that the seizure severity was unchanged, and a score of -3 that the seizure severity was very much worse.

The results of the three primary endpoints are shown in Table 7 below.

Pediatric Patients ages 1 to less than 4 years

The effectiveness of Banzel as adjunctive treatment for the seizures associated with Lennox-Gastaut Syndrome in pediatric patients ages 1 year to less than 4 years was established based on a single multi-center, open-label, active-controlled, randomized, pharmacokinetic bridging study. The pharmacokinetic profile of Banzel is not significantly affected by age either as a continuous covariate (1 to 35 years) or as a categorical covariate (age categories: 1 to less than 4 years and 4 years of age and older), after body weight is taken into consideration.

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Administration Information

• Advise patients to take Banzel with food [see Dosage and Administration (2.2)].
  
• Advise patients who are prescribed the oral suspension to shake the bottle vigorously before every administration and to use the adaptor and oral dosing syringe [see Dosage and Administration (2.2)].

Suicidal Thinking and Behavior

Inform patients, their caregivers, and families that antiepileptic drugs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers [see Warnings and Precautions (5.1)].

Central Nervous System Reactions

Inform patients about the potential for somnolence or dizziness and advise them not to drive or operate machinery until they have gained sufficient experience on Banzel to gauge whether it adversely affects their mental and/or motor performance [see Warnings and Precautions (5.2)].

Multi-Organ Hypersensitivity Reactions

Advise patients to notify their physician if they experience a rash associated with fever [see Warnings and Precautions (5.4)].

Drug Interactions

• Inform female patients of childbearing age that the concurrent use of Banzel with hormonal contraceptives may render this method of contraception less effective. Recommend patients use additional non-hormonal forms of contraception when using Banzel [see Drug Interactions (7.3)]. 
  
• Inform patients that alcohol in combination with Banzel may cause additive central nervous system effects.

Pregnancy

Advise patients to notify their physician if they become pregnant or intend to become pregnant during therapy. Encourage patients to enroll in the North American Antiepileptic Drug Pregnancy Registry if they become pregnant. To enroll, patients can call the toll free number 1-888-233-2334 [see Use in Specific Populations (8.1)].

Breast-feeding

Advise patients to notify their physician if they are breast-feeding or intend to breast-feed [see Use in Specific Populations (8.3)].

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:

• thoughts about suicide or dying
  
• attempt to commit suicide
  
• new or worse depression
  
• new or worse anxiety
  
• feeling agitated or restless
  
• panic attacks
  
• trouble sleeping (insomnia)
  
• new or worse irritability
  
• acting aggressive, being angry, or violent
  
• acting on dangerous impulses
  
• an extreme increase in activity and talking (mania)
  
• other unusual changes in behavior or mood
  
• Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

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

• Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
  
• Keep all follow-up visits with your healthcare provider as scheduled.

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.  

• Stopping Banzel suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

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:

• have heart problems
  
• have liver problems
  
• have any other medical problems
  
• have or have had suicidal thoughts or actions, depression or mood problems
  
• are pregnant or plan to become pregnant. It is not known if Banzel can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Banzel. You and your healthcare provider will decide if you should take Banzel while you are pregnant.
  
• Banzel may make certain types of birth control less effective. Talk to your healthcare provider about the best birth control methods for you while you take Banzel.
  ○ If you become pregnant while taking Banzel, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy.
  
• are breastfeeding or plan to breastfeed. Banzel may pass into your breast milk. You and your healthcare provider should decide if you will take Banzel or breastfeed. You should not do both.

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?

• Take Banzel exactly as your healthcare provider tells you. Your healthcare provider will tell you how much Banzel to take.
  
• Your healthcare provider may change your dose. Do not change your dose of Banzel without talking to your healthcare provider.
  
• Take Banzel with food.
  
• Banzel tablets can be swallowed whole, cut in half or crushed.
  
• If you take Banzel Oral Suspension instead of Banzel tablets, shake the bottle well before you take each dose. Measure your dose of Banzel Oral Suspension using the bottle adapter and dosing syringes provided.
  
  See the complete Instructions for Use below for information on how to use the dosing syringes and measure your dose of Banzel Oral Suspension.
  
  
• If you take too much Banzel, call your local Poison Control Center or get emergency medical help right away.

What should I avoid while taking Banzel?

• Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking Banzel until you talk to your healthcare provider. Banzel taken with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
  
• Do not drive, operate heavy machinery, or do other dangerous activities until you know how Banzel affects you. Banzel can slow your thinking and motor skills.

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:

• Banzel can also cause allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions.

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

• swelling of your face, eyes, lips, or tongue 
  
• trouble swallowing or breathing
  
• a skin rash
  
• hives
  
• fever, swollen glands, or sore throat that do not go away or come and go
  
• swollen glands
  
• yellowing of your skin or eyes
  
• dark urine
  
• unusual bruising or bleeding
  
• severe fatigue or weakness
  
• severe muscle pain
  
• your seizures happen more often or become worse

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

The most common side effects of Banzel include:

• headache
  
• dizziness
  
• tiredness
  
• sleepiness
  
• nausea
  
• vomiting

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?

• Store Banzel tablets and oral suspension at 59ºF to 86ºF (15ºC to 30ºC).

Tablets

• Keep Banzel tablets in a dry place.

Oral Suspension

• Replace the cap securely after opening.
  
• Keep Banzel Oral Suspension in an upright position.
  
• Use Banzel Oral Suspension within 90 days of first opening the bottle.

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., Woodcliff Lake, NJ 07677

Revised June 2015

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

© 2015 Eisai Inc.

Instructions for Use
Banzel (ban-‘zel)
[rufinamide]
Oral Suspension

Read the Instructions for Use before using Banzel Oral Suspension and each time you get a refill. There may be new information. This leaflet does not take the place of talking with the doctor about your medical condition or treatment.

Prepare the Banzel Oral Suspension dose

You will need the following supplies: See Figure A

• Banzel Oral Suspension bottle
  
• Bottle adapter
  
• Dosing syringe (2 dosing syringes are included in the Banzel Oral Suspension box)

Figure A

Step 1. Remove the Banzel Oral Suspension bottle, bottle adapter, and 2 syringes from the box. See Figure A

Step 2. Shake the bottle well before each use. See Figure B

Figure B

Step 3. Uncap the bottle and insert the bottle adapter into the bottle. See Figure C 

Figure C

Once the bottle adapter is installed, it cannot be removed. See Figure D

Figure D

Step 4. Check the morning or evening dose in milliliters (mL) as prescribed by your doctor. Locate this number on the syringe. See Figure E

Figure E

Step 5. Insert the syringe into the upright bottle and push the plunger all the way down. See Figure F

Figure F

Step 6. With the syringe in place, turn the bottle upside down. Pull the plunger to the number of mL needed (the amount of liquid medicine in Step 4). See Figure G

Figure G

Measure the mLs of medicine from the white layer at the end of the plunger, not the black layer. See Figure H

Figure H

Step 7. If the dose is more than 20 mL, you can either use:

• 2 syringes, or

• 1 syringe, taking two steps to draw up the medicine in that same syringe

For example:

If your dose is 30 mL, draw up 20 mL in the first syringe and the remaining 10 mL in the second syringe.

or

If your dose is 30 mL, draw up 20 mL in the single syringe and squirt the medicine into your mouth, then draw up the remaining 10 mL in that same syringe.

Repeat Steps 4 through 6 when drawing up the remaining dose of medicine, if your dose is more than 20 mL.

Step 8. Remove the syringe from the bottle adapter.

Step 9. Slowly squirt Banzel directly into the corner of your mouth. If you need 2 syringes for your dose, slowly squirt the medicine from the first syringe into your mouth, then slowly squirt the medicine from the second syringe into your mouth. See Figure I

Figure I

Step 10. Rinse the syringe (or syringes) with tap water after each use. See Figure J

• Fill a cup with water
  
• Pull back on the plunger and draw the water from the cup into the syringe
  
• Push on the plunger to release the water into the sink

Figure J

Step 11. Cap the bottle tightly. The cap will fit over the bottle adapter. Store the bottle upright at 59°F to 86°F (15°C to 30°C). See Figure K

Figure K

PRINCIPAL DISPLAY PANEL

NDC 62856-582-52
Banzel® 
(rufinamide) TABLETS
200 mg
120 tablets

PRINCIPAL DISPLAY PANEL

NDC 62856-583-52
Banzel®
(rufinamide) TABLETS
400 mg
120 tablets

PRINCIPAL DISPLAY PANEL

NDC 62856-584-46
Banzel®
(rufinamide) ORAL SUSPENSION
40 mg/mL
460 mL

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

Before taking Banzel, tell your doctor if you have heart disease, liver disease, kidney disease (or if you are on dialysis), or a history of depression, mental illness, or suicidal thoughts or actions.

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

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.

Do not stop using Banzel suddenly or you may have increased seizures.

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

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

Banzel may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you.

Drinking alcohol can increase certain side effects of Banzel.

Common side effects of Banzel include: seizure, dizziness, drowsiness, fatigue, headache, nausea, and vomiting. Other side effects include: status epilepticus, ataxia, blurred vision, diplopia, and skin rash. See below for a comprehensive list of adverse effects.

Applies to rufinamide: oral suspension, oral tablet

Along with its needed effects, rufinamide (the active ingredient contained in Banzel) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking rufinamide:

• Dizziness
• shakiness in the legs, arms, hands, or feet
• sleepiness or unusual drowsiness
• trembling or shaking of the hands or feet
• uncontrolled eye movements

• Attack, assault, or force
• black, tarry stools
• chest pain
• chills
• cough
• cough producing mucus
• diarrhea
• difficult or painful urination
• difficulty with breathing
• dizziness or lightheadedness
• fear or nervousness
• feeling of constant movement of self or surroundings
• fever
• general feeling of discomfort or illness
• headache
• joint pain
• loss of appetite
• muscle aches and pains
• nausea
• pain or tenderness around the eyes and cheekbones
• rash
• restlessness
• sensation of spinning
• shakiness and unsteady walk
• shivering
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stuffy or runny nose
• sweating
• swollen glands
• tightness in the chest
• trouble sitting still
• trouble sleeping
• trouble walking
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

• Bleeding gums
• blood in the urine or stools
• burning while urinating
• fainting
• frequent urination
• inability to hold urine
• increased urge to urinate during the night
• increased volume of pale, dilute urine
• lower back or side pain
• pale skin
• pinpoint red spots on the skin
• pounding, slow heartbeat
• sore tongue
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• troubled breathing with exertion
• waking to urinate at night

Some side effects of rufinamide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Blurred vision
• double vision
• seeing double

• Acid or sour stomach
• back pain
• belching
• change in hearing
• decreased appetite
• difficulty having a bowel movement (stool)
• ear drainage
• earache or pain in the ear
• heartburn
• indigestion
• itching skin
• stomach discomfort, upset, or pain
• upper abdominal or stomach pain

• Increased appetite