Rufinamide, Oral

________________________________________________________________________

KEY POINTS

• This medicine is taken by mouth to treat seizures. Take it exactly as directed. Carry some form of identification stating that you have seizures and are taking an antiseizure medicine.
• This medicine may increase suicidal thoughts or actions in some people.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Do not start or stop taking any other medicine without your healthcare provider’s advice.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: antiseizure

Generic and brand names: rufinamide, oral; Banzel

What is this medicine used for?

This medicine is used along with other medicines to treat seizures caused by Lennox-Gastaut syndrome.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Depression or thoughts of suicide
• Heart disease or an irregular heartbeat
• Liver disease
• Short QT syndrome (problems with electrical activity in the heart muscle)

This medicine may make hormonal birth control less effective. If you need birth control, talk to your healthcare provider about methods that are effective while you are taking this medicine.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Contact your healthcare provider right away if you become pregnant while taking this medicine. You and your healthcare provider should decide if you should continue taking this medicine while you are pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Your healthcare provider may change your dosage, depending on your response and any side effects you may have. Be sure you know exactly how much to take each day and when to take each dose. This medicine must be taken regularly every day to control seizures. Do not stop taking this medicine without your healthcare provider's approval. You may have to gradually reduce your dosage. If you stop taking the medicine too quickly, your seizures may increase.

Check with your healthcare provider before using this medicine in children under age 1.

This medicine comes in tablets and liquid. The tablets can be swallowed whole, cut in half, or crushed. If you take the liquid, shake the bottle well before you take each dose. Measure your dose using the bottle adapter and dosing syringes provided. Ask your pharmacist if you have any questions.

Take this medicine with food.

What if I miss a dose?

Do not miss a dose. If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: trouble walking, loss of balance, drowsiness, passing out, nausea, slow breathing, vision problems, coma.

What should I watch out for?

Antiseizure medicines may increase suicidal thoughts or actions in some people. Call your healthcare provider right away if you have new or worsening depression, any unusual changes in mood or behavior, or new or increased thoughts of suicide.

Do not start or stop taking any other medicine without your healthcare provider’s advice. Other medicine may affect how this medicine works.

This medicine may cause serious side effects that can affect your liver or kidneys. Contact your healthcare provider right away if you have a fever or rash, yellowing of the skins or eyes, dark urine, severe stomach pain, loss of appetite, unusual tiredness, or trouble urinating.

This medicine may make you drowsy or dizzy. Do not drive or operate machinery unless you are fully alert.

This medicine may increase the effects of alcohol and other drugs that slow down your nervous system. Do not drink alcohol or take other medicines unless your healthcare provider approves.

Your healthcare provider will want to check your progress regularly and adjust your dosage. Keep all appointments.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. Carry some form of ID stating that you have seizures and are taking an antiseizure medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Severe nausea or vomiting, sudden stomach pain, loss of appetite, blood in your urine, dark urine, yellowing of skin or eyes, severe or unusual tiredness, trouble urinating, confusion, unusual mood or behavior changes, depression or thoughts of suicide, vision problems, uncontrollable eye or muscle twitches, slurred speech, increased seizures, fast or irregular heartbeat, skin rash, fever, chest pain, trembling, trouble breathing, severe dizziness or fainting, sore throat, fever, swollen glands, unusual bruising or bleeding, unusual paleness or weakness, trouble walking, loss of coordination or balance.

Other: Mild drowsiness or dizziness, mild nausea or vomiting, constipation, headache, stuffy or runny nose.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antianxiety medicines such as alprazolam (Xanax), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antidepressants such as amitriptyline, duloxetine (Cymbalta), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), and venlafaxine (Effexor)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), and hydroxyzine (Vistaril)
• Antipsychotic medicines such as aripiprazole (Abilify), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), olanzapine (Zyprexa), perphenazine, pimozide (Orap), thioridazine, and trifluoperazine
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), clobazam (Onfi), eslicarbazepine (Aptiom), ethosuximide (Zarontin), fosphenytoin (Cerebyx), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), methsuximide (Celontin), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), primidone (Mysoline), topiramate (Qudexy, Topamax, Trokendi), valproic acid (Depacon, Depakene, Depakote), vigabatrin (Sabril), and zonisamide (Zonegran)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Doxepin (Silenor)
• Heart medicines such as digoxin (Lanoxin), mexiletine, and ranolazine (Ranexa)
• Hormonal birth control pills, implants, shots, patches, vaginal rings, and IUDs, and hormones such as conjugated estrogens (Premarin), estradiol (Climara, Estrace, Estraderm, Vivelle), medroxyprogesterone (Depo-Provera, Provera), and norethindrone (Aygestin, Micronor)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), chlorzoxazone (Lorzone, Parafon Forte), cyclobenzaprine (Amrix), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Narcotic pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), and pentazocine (Talwin)
• Natural remedies such as evening primrose, gotu kola, kava, St. John's wort, and valerian
• Nausea medicines such as prochlorperazine (Compro) and promethazine
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Sleeping pills such as eszopiclone (Lunesta), flurazepam, suvorexant (Belsomra), temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)

Do not drink alcohol unless your healthcare provider approves.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Do not refrigerate. Do not let it freeze. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

If you have the liquid, use the medicine within 90 days of first opening the bottle.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.