Oxcarbazepine, 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.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: antiseizure

Generic and brand names: oxcarbazepine, oral; Oxtellar XR; Trileptal

What is this medicine used for?

This medicine is taken by mouth to treat seizures. It may be used alone or with other seizure medicine.

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

• An allergic reaction to any medicine
• Depression or thoughts of suicide
• Low levels of sodium in your blood
• Kidney or liver problems

If you are of Asian ancestry, you may be at high risk of a serious skin reaction. Your provider may give you a blood test to find out if you carry the HLA-A*3101 or HLA-B*1502 gene. If the test is positive, you are at high risk for severe reaction. Talk with your provider about this.

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 increase 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. Do not stop taking this medicine without your healthcare provider's approval. Your seizures may get worse if you suddenly stop taking this medicine. You may have to reduce your dosage gradually.

Check with your healthcare provider before using this medicine in children. Some forms of this medicine should not be used in children under a certain age.

This medicine comes in regular tablets, extended-release tablets, and liquid.

Regular tablets and liquid (Trileptal): You may take the regular tablets or liquid form of this medicine with or without food. If you are taking the liquid, be sure to shake the bottle well before taking a dose. Use the oral dosing syringe supplied with the medicine package to measure the amount of medicine needed. The liquid can be mixed in a small glass of water, or swallowed directly from the syringe. Ask your pharmacist if you have any questions about how to use the liquid.

Extended-release tablets (Oxtellar XR): The extended-release tablets are usually taken once a day. Take them on an empty stomach at least 1 hour before or 2 hours after food. Swallow the extended-release tablets whole with water. Do not cut, crush, or chew the extended-release tablets.

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: dizziness, drowsiness, double vision, trouble walking, lack of coordination, slow heartbeat, seizures, 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.

Rarely, this medicine may cause serious skin reactions. Contact your healthcare provider immediately if you develop any kind of rash or skin problem while taking this medicine.

This medicine may cause the sodium level in your blood to be low. Contact your healthcare provider if you have any symptoms of low sodium such as severe nausea, extreme tiredness, headache, confusion, or more frequent or severe seizures. If your symptoms do not improve within a few days or get worse, contact your healthcare provider.

Your healthcare provider will check your progress regularly and adjust your dosage. You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments.

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 skin or eyes, dark urine, severe stomach pain, loss of appetite, unusual bruising or bleeding, unusual tiredness, trouble urinating, or any signs of infection such as fever, chills, or sore throat.

If you take this medicine for a long time, it may affect bone density. Your healthcare provider may order tests to determine if this medicine is affecting your bones.

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

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

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. Carry an ID card or a Medic Alert bracelet. If you become unconscious, the ID tells emergency healthcare providers that you may need special care.

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.): Depression or thoughts of suicide; unusual changes in mood or behavior; trouble concentrating; trouble walking or talking; unusual bruising or bleeding; yellowing of skin or eyes; severe stomach pain; loss of appetite; dark urine; trouble urinating; increased seizures; rash, blistering or peeling skin, or any skin problem; trouble swallowing or breathing; unexplained fever, cough, or sore throat; swollen lymph nodes, muscle or joint pain; extreme drowsiness or confusion; severe or continued headache; vision changes; loss of coordination; mouth sores or sores around your eyes; severe weakness or tiredness; severe dizziness or fainting.

Other: Headache, mild dizziness, mild drowsiness, nausea, vomiting, mild stomach pain, heartburn, trouble sleeping, nervousness, mild tiredness, diarrhea, runny nose, tremors.

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:

• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), and silodosin (Rapaflo)
• Antianxiety medicines such as alprazolam (Xanax), buspirone, clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antibiotics such as bedaquiline (Sirturo), clarithromycin (Biaxin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, venlafaxine (Effexor), vilazodone (Viibryd), and vortioxetine (Trintellix)
• Antifungal medicines such as itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), and hydroxyzine (Vistaril)
• Antipsychotic medicines such as aripiprazole (Abilify), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), lurasidone (Latuda), olanzapine (Zyprexa), perphenazine, pimozide (Orap), quetiapine (Seroquel), thioridazine, and trifluoperazine
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), clobazam (Onfi), eslicarbazepine (Aptiom), ethosuximide (Zarontin), felbamate (Felbatol), fosphenytoin (Cerebyx), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), phenobarbital, phenytoin (Dilantin, Phenytek), primidone (Mysoline), rufinamide (Banzel), tiagabine (Gabitril), topiramate (Qudexy, Topamax, Trokendi), valproic acid (Depacon, Depakene, Depakote), vigabatrin (Sabril), and zonisamide (Zonegran)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir (Technivie), ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira), and simeprevir (Olysio)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Cancer medicines such as abiraterone (Zytiga), axitinib (Inlyta), bortezomib (Velcade), bosutinib (Bosulif), enzalutamide (Xtandi), etoposide, ibrutinib (Imbruvica), ifosfamide (Ifex), imatinib (Gleevec), nilotinib (Tasigna), nilutamide (Nilandron), olaparib (Lynparza), osimertinib (Tagrisso), palbociclib (Ibrance), pazopanib (Votrient), sonidegib (Odomzo), and sunitinib (Sutent)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), lomitapide (Juxtapid), lovastatin (Altoprev), and simvastatin (Zocor)
• Cimetidine (Tagamet)
• Cystic fibrosis medicines such as ivacaftor (Kalydeco) and lumacaftor/ivacaftor (Orkambi)
• Dexamethasone
• Diabetes medicines such as linagliptin (Tradjenta), nateglinide (Starlix), repaglinide (Prandin), and saxagliptin (Onglyza)
• Diuretics (water pills) such as chlorothiazide (Diuril), chlorthalidone, hydrochlorothiazide (Microzide), and methyclothiazide (Enduron)
• Doxepin (Silenor)
• Exemestane (Aromasin)
• Flibanserin (Addyi)
• Heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia, Tiazac), disopyramide (Norpace), dronedarone (Multaq), felodipine, isradipine (DynaCirc), losartan (Cozaar), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nisoldipine (Sular), quinidine, ranolazine (Ranexa), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), dolutegravir (Tivicay), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), rilpivirine (Edurant), ritonavir (Norvir), and saquinavir (Invirase)
• 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)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Macitentan (Opsumit)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to treat breathing or lung problems such as aminophylline, roflumilast (Daliresp), theophylline, and zafirlukast (Accolate)
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), clopidogrel (Plavix), rivaroxaban (Xarelto), and ticagrelor (Brilinta)
• Mifepristone (Korlym, Mifeprex)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Natural remedies such as evening primrose oil, ginkgo, gotu kola, kava, St. John's wort, and valerian
• Nausea medicines such as aprepitant (Emend), ondansetron (Zofran), prochlorperazine (Compro), and promethazine
• Pain medicines such as buprenorphine (Buprenex, Butrans), 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), pentazocine (Talwin), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Praziquantel (Biltricide)
• Sevelamer (Renagel, Renvela)
• Sleeping pills such as butabarbital (Butisol), eszopiclone (Lunesta), flurazepam, suvorexant (Belsomra), temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)
• Tadalafil (Adcirca, Cialis)
• Tofacitinib (Xeljanz)

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

If you have the liquid, keep it in the original container. Use within 7 weeks 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.