Felbamate, Oral

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KEY POINTS

• This medicine is taken by mouth to treat seizures that have not responded to other medicines. Take it exactly as directed.
• This medicine may increase suicidal thoughts or actions in some people.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine can cause serious or life-threatening side effects, including liver damage and anemia. This medicine may also cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Carry some form of ID stating that you have seizures and are taking this medicine. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antiseizure

Generic and brand names: felbamate, oral; Felbatol

What is this medicine used for?

This medicine is taken by mouth to treat seizures that have not responded to other medicines. It may be used alone or with other medicines.

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
• Blood cell diseases such as anemia
• Depression or thoughts of suicide
• Kidney disease
• Liver disease

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. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take 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. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval. Suddenly stopping could cause your seizures to become more frequent or severe.

Check with your healthcare provider before using this medicine in children under age 2.

This medicine is available in tablets and a liquid. If you have the liquid form of this medicine, shake it well before measuring a dose. Use the measuring spoon, cup, dropper, or oral syringe that comes with the medicine, or ask your pharmacist for one. Do not use a kitchen spoon because the dose may not be correct.

Your healthcare provider may prescribe other medicines to be taken with this one. Be sure you know the dosage schedule for all medicines prescribed for you, and follow directions carefully.

What if I 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: nausea, vomiting, fast heartbeat, drowsiness.

What should I watch out for?

This medicine can cause serious or life-threatening side effects. You will have to sign an informed consent form before you start taking this medicine.

Contact your healthcare provider right away if you experience a fever, sore throat, chills, mouth sores, or any other signs of infection; unusual bruising or bleeding, unusual tiredness or weakness. These may be signs of a serious or life-threatening condition called aplastic anemia. You may have these symptoms while you are taking this medicine or after you stop taking this medicine.

Contact your healthcare provider right away if you have dark urine, yellowing of your skin or eyes, unexplained loss of appetite, unusual tiredness, nausea, vomiting or pain in your abdomen. These may be signs of liver damage.

Antiseizure medicines may increase suicidal thoughts or actions in some people. Call your healthcare provider right away if you or your family notices any disturbing changes in your thoughts or behavior, such as: more outgoing or aggressive behavior than normal, confusion, hallucinations, new or worsening depression, or suicidal thoughts.

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine may make your skin more sensitive to the sun and may cause you to sunburn more easily. While you are taking this medicine, avoid long exposure to the sun. While you are in the sun, wear protective clothing and sunscreen lotion until you know how you will react to the sun. Do not use a sunlamp. If you get a severe sunburn, contact your healthcare provider right away.

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

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

You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may help. Also, drinking alcohol may make it worse. Do not drink alcohol unless you healthcare provider approves.

Carry some form of identification stating that you have seizures and are taking this medicine. If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this 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; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): A severe skin rash; peeling skin; unusual bruising or bleeding; sore throat, fever, chills; infections that come and go, and that don’t go away; dark urine; yellowing of your skin or eyes; severe nausea, vomiting, or stomach pain; blood in the urine; unusual tiredness or weakness; fast or irregular heartbeat; shortness of breath; new or worsening depression; suicidal thoughts; unusual mood changes or behavior; confusion; trouble walking; vision changes; facial swelling; worsening seizures.

Other: Tiredness, trouble sleeping, headache, anxiety, vomiting, diarrhea, constipation, dizziness, change in sense of taste, shakiness, dry mouth, hiccups, runny or stuffy nose, weight loss or gain, nausea, itching.

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:

• Anagrelide (Agrylin)
• Antianxiety medicines such as alprazolam (Xanax), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antibiotics such as chloramphenicol, ciprofloxacin (Cipro), clarithromycin (Biaxin), levofloxacin (Levaquin), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), nefazodone, and sertraline (Zoloft)
• Antifungal medicines such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), hydroxyzine (Vistaril), and meclizine (Dramamine)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, fluphenazine, haloperidol (Haldol), iloperidone (Fanapt), olanzapine (Zyprexa), paliperidone (Invega), perphenazine, pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), eslicarbazepine (Aptiom), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), primidone (Mysoline), and valproic acid (Depacon, Depakene, Depakote)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira) and ombitasvir/paritaprevir/ritonavir (Technivie)
• Bosentan (Tracleer)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Calcium channel blockers such as diltiazem (Cardizem, Cartia, Tiazac), nicardipine (Cardene), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as arsenic trioxide (Trisenox), ceritinib (Zykadia), crizotinib (Xalkori), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), lapatinib (Tykerb), mitotane (Lysodren), nilotinib (Tasigna), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cisapride
• Clopidogrel (Plavix)
• Conivaptan (Vaprisol)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Flibanserin (Addyi)
• Heart medicines such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), procainamide, quinidine, and ranolazine (Ranexa)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings (Talk to your healthcare provider if you need birth control.)
• Lumacaftor/ivacaftor (Orkambi)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Mifepristone (Korlym, Mifeprex)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Narcotic pain medicines such as buprenorphine (Buprenex, Butrans), codeine, hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), and oxycodone (OxyContin, Roxicodone)
• Natural remedies such as chaparral, coltsfoot, comfrey, evening primrose oil, ginkgo biloba, gotu kola, kava, St. John's wort, and valerian
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), netupitant/palonosetron (Akynzeo), ondansetron (Zofran), prochlorperazine (Compro), and promethazine
• Orlistat (alli, Xenical)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Sleeping pills such as eszopiclone (Lunesta), flurazepam, suvorexant (Belsomra), temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)
• Tetrabenazine (Xenazine)

Do not drink alcohol while taking this medicine without your healthcare provider's approval.

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, or tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

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. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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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.