These highlights do not include all the information needed to use APTIOM safely and effectively. See full prescribing information for APTIOM. APTIOM® (eslicarbazepine acetate) tablets, for oral useInitial U.S. Approval: 2013

This Medication Guide has been approved by the U.S. Food and Drug Administration.							Revised 9/2017
MEDICATION GUIDE APTIOM (ap tee' om) (eslicarbazepine acetate) tablets
What is the most important information I should know about APTIOM? Do not stop taking APTIOM without first talking to your healthcare provider. Stopping APTIOM suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy may cause seizures that will not stop (status epilepticus).
1. Like other antiepileptic drugs, APTIOM 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 new or worse depression feeling agitated or restless trouble sleeping (insomnia) acting aggressive, being angry, or violent an extreme increase in activity and talking (mania)				attempt to commit suicide new or worse anxiety panic attacks new or worse irritability acting on dangerous impulses other unusual changes in behavior or mood
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. Suicidal thoughts or actions may be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
2. APTIOM may 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:
swelling of your face, eyes, lips, or tongue a skin rash fever, swollen glands, or sore throat that do not go away or come and go yellowing of your skin or eyes severe fatigue or weakness frequent infections or infections that do not go away				trouble swallowing or breathing hives painful sores in the mouth or around your eyes unusual bruising or bleeding severe muscle pain
APTIOM may cause the level of sodium in your blood to be low. Symptoms of low blood sodium include:
nausea irritability muscle weakness or muscle spasms				tiredness, lack of energy confusion more frequent or more severe seizures
Some medicines can also cause low sodium in your blood. Be sure to tell your healthcare provider about all the other medicines that you are taking.
What is APTIOM? APTIOM is a prescription medicine used to treat partial-onset seizures. It is not known if APTIOM is safe and effective in children under 4 years of age.
Who should not take APTIOM? Do not take APTIOM if you are allergic to eslicarbazepine acetate, any of the other ingredients in APTIOM, or oxcarbazepine. See the end of this Medication Guide for a complete list of ingredients in APTIOM.
What should I tell my healthcare provider before taking APTIOM? Before taking APTIOM, tell your healthcare provider about all your medical conditions, including if you: have or have had suicidal thoughts or actions, depression or mood problems have liver, kidney, or blood problems are allergic to oxcarbazepine. Some people who are allergic to oxcarbazepine may also be allergic to APTIOM. use birth control medicine. APTIOM may cause your birth control medicine to be less effective. Talk to your healthcare provider about the best birth control method to use. are pregnant or plan to become pregnant. APTIOM may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking APTIOM. You and your healthcare provider will decide if you should take APTIOM while you are pregnant. If you become pregnant while taking APTIOM, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334. are breastfeeding or plan to breastfeed. APTIOM passes into breast milk. You and your healthcare provider should discuss whether you should take APTIOM or breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking APTIOM with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider. Especially tell your healthcare provider if you take:
oxcarbazepine phenobarbital	carbamazepine phenytoin		simvastatin birth control medicine		omeprazole rosuvastatin		clobazam primidone
Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take APTIOM? Take APTIOM exactly as your healthcare provider tells you to take it. Do not stop taking APTIOM without talking to your healthcare provider. Stopping APTIOM suddenly can cause serious problems, including seizures that will not stop (status epilepticus). Your healthcare provider may change your dose. Your healthcare provider will tell you how much APTIOM to take. APTIOM can be taken with or without food. APTIOM can be taken as a whole tablet or crushed. If you take too much APTIOM, call your healthcare provider or go to the nearest hospital emergency room right away. Talk with your healthcare provider about what you should do if you miss a dose.
What should I avoid while taking APTIOM? Do not drive, operate heavy machinery, or do dangerous activities until you know how APTIOM affects you. APTIOM may slow your thinking and motor skills.
What are the possible side effects of APTIOM? See “What is the most important information I should know about APTIOM?” APTIOM may cause other serious side effects including: Nervous system problems. APTIOM may cause problems that can affect your nervous system. Symptoms of nervous system problems include:
dizziness trouble concentrating		trouble walking or with coordination vision problems				feeling sleepy and tired
Liver problems. APTIOM may affect your liver. Symptoms of liver problems include:
yellowing of your skin or the whites of your eyes stomach pain		nausea or vomiting dark urine				loss of appetite
Get medical help right away if you have any of the symptoms listed above or listed in “What is the most important information I should know about APTIOM?” The most common side effects of APTIOM include:
dizziness vomiting	sleepiness feeling tired		nausea blurred vision		headache shakiness		double vision problems with coordination
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of APTIOM. 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 APTIOM? Store APTIOM at 68oF to 77oF (20oC to 25oC). Safely throw away medicine that is out of date or no longer needed.
Keep APTIOM and all medicines out of reach of children.
What are the ingredients in APTIOM? Active ingredient: eslicarbazepine acetate Inactive ingredients: croscarmellose sodium, magnesium stearate, and povidone
General information about the safe and effective use of APTIOM. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use APTIOM for a condition for which it was not prescribed. Do not give APTIOM 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 APTIOM. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about APTIOM that is written for health professionals. For more information, go to www.aptiom.com or call 1-888-394-7377.
Manufactured for: Sunovion Pharmaceuticals Inc., Marlborough, MA 01752 USA Under license from © 2023 Sunovion Pharmaceuticals Inc. All rights reserved.

Revised: 11/2023

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Version: 16

Effective Time: 20231110

Sumitomo Pharma America, Inc.