Eslicarbazepine Tablets

What is this medication?

ESLICARBAZEPINE (es lye kar bay ze peen) prevents and controls seizures in people with epilepsy. It works by calming overactive nerves in your body.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Aptiom

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Kidney disease
• Liver disease
• Suicidal thoughts, plans, or attempt by you or a family member
• Any unusual or allergic reaction to eslicarbazepine, oxcarbazepine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. This medication may be taken with or without food. Take your doses at regular intervals. Do not take your medication more often than directed. Do not stop taking except on the advice of your care team.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 4 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Lonafarnib
• MAOIs, such as Marplan, Nardil, and Parnate
• Mavacamten
• Oxcarbazepine
• Ranolazine
• Rilpivirine

This medication may also interact with the following:

• Certain medications for seizures, such as carbamazepine, clobazam, phenobarbital, phenytoin, primidone
• Estrogen and progestin hormones
• Omeprazole
• Rosuvastatin
• Simvastatin
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Do not suddenly stop taking this medication. You may develop a severe reaction. Your care team will tell you how much medication to take. If your care team wants you to stop the medication, the dose may be slowly lowered over time to avoid any side effects.

Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the medications and doses you take on the card.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

This medication may cause thoughts of suicide or depression. This includes sudden changes in mood, behaviors, or thoughts. These changes can happen at any time but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you experience these thoughts or worsening depression.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. You may also notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

Tell your care team right away if you have any change in your eyesight.

Estrogen and progestin hormones may not work as well while you are taking this medication. Your care team can help you find the contraceptive option that works for you.

Women who become pregnant while using this medication may enroll in the North American Antiepileptic Medication Pregnancy Registry by calling 1-888-233-2334. This registry collects information about the safety of antiepileptic medication use during pregnancy.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Infection—fever, chills, cough, or sore throat
• Low sodium level—muscle weakness, fatigue, dizziness, headache, confusion
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Thoughts of suicide or self-harm, worsening mood, or feelings of depression

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Difficulty with paying attention, memory, or speech
• Dizziness
• Double vision
• Drowsiness
• Headache
• Loss of balance or coordination
• Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.