Eslicarbazepine

What is eslicarbazepine used for?

• Eslicarbazepine is used to help control certain kinds of seizures.

Before taking eslicarbazepine, tell your doctor:

• If you are allergic to eslicarbazepine; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have liver disease.
• If you are taking oxcarbazepine.

This is not a list of all drugs or health problems that interact with eslicarbazepine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take eslicarbazepine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take eslicarbazepine?

For all patients taking eslicarbazepine:

• Tell all of your health care providers that you take eslicarbazepine. This includes your doctors, nurses, pharmacists, and dentists.
• Very bad and sometimes deadly allergic side effects have rarely happened. Talk with your doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how eslicarbazepine affects you.
• Do not stop taking eslicarbazepine all of a sudden without calling your doctor. You may have a greater risk of seizures. If you need to stop eslicarbazepine, you will want to slowly stop it as ordered by your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• A severe and sometimes deadly reaction has happened. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. If you have questions, talk with the doctor.
• Patients who take eslicarbazepine may be at a greater risk of having thoughts or actions of suicide. The risk may be greater in people who have had these thoughts or actions in the past. Call the doctor right away if signs like low mood (depression), nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.
• Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking eslicarbazepine.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking eslicarbazepine, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Children:

• If your child's weight changes, talk with the doctor. The dose of eslicarbazepine may need to be changed.

How is eslicarbazepine best taken?

Use eslicarbazepine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• This medicine can be taken as a whole tablet or crushed.
• Keep taking eslicarbazepine as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you are not sure what to do if you miss a dose, call your doctor.

What are the side effects of eslicarbazepine that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low sodium levels like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Swollen gland.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Chest pain or pressure.
• Very bad dizziness or passing out.
• Very bad muscle pain or weakness.
• Change in eyesight.
• If seizures are worse or not the same after starting eslicarbazepine.
• Not able to control eye movements.
• Trouble walking.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• Rarely, low blood cell counts have happened with eslicarbazepine. Call your doctor right away if you have any unexplained bruising or bleeding; signs of infection like fever, chills, or sore throat; or feel very tired or weak.
• A very bad reaction called angioedema has happened with eslicarbazepine. Sometimes, this may be life-threatening. Signs may include swelling of the hands, face, lips, eyes, tongue, or throat; trouble breathing; trouble swallowing; or unusual hoarseness. Get medical help right away if you have any of these signs.

What are some other side effects of eslicarbazepine?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Feeling dizzy, sleepy, tired, or weak.
• Upset stomach or throwing up.
• Shakiness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out eslicarbazepine?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use and disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time eslicarbazepine is refilled. If you have any questions about eslicarbazepine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take eslicarbazepine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to eslicarbazepine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.