Uses of Trileptal:

• It is used to help control certain kinds of seizures.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Trileptal?

• If you have an allergy to oxcarbazepine or any other part of Trileptal (oxcarbazepine tablets).
• If you are allergic to Trileptal (oxcarbazepine tablets); any part of Trileptal (oxcarbazepine tablets); 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 have been tested and know that you have a gene type called HLA-B*1502.

This is not a list of all drugs or health problems that interact with Trileptal (oxcarbazepine tablets).

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 Trileptal (oxcarbazepine tablets) 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 Trileptal?

• Tell all of your health care providers that you take Trileptal (oxcarbazepine tablets). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Trileptal (oxcarbazepine tablets) affects you.
• 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.
• Patients who take Trileptal (oxcarbazepine tablets) 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.
• A very bad and sometimes deadly effect has happened in people taking drugs for seizures like Trileptal (oxcarbazepine tablets). Call your doctor right away if you have swollen glands; fever; rash; chest pain; unable to pass urine or change in the amount of urine passed; or 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.
• 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.
• People with a certain gene (HLA-B*1502) have a higher chance of severe and sometimes deadly skin reactions with Trileptal (oxcarbazepine tablets). This gene is more common in Asian people. If you have questions, talk with the doctor.
• A very bad reaction called angioedema has happened with Trileptal (oxcarbazepine tablets). 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.
• If you are 65 or older, use Trileptal (oxcarbazepine tablets) with care. You could have more side effects.
• 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 Trileptal (oxcarbazepine tablets).
• 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 Trileptal (oxcarbazepine tablets), call your doctor right away.
• This medicine may not work as well during pregnancy. Talk with the doctor.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Trileptal) best taken?

Use Trileptal (oxcarbazepine tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Keep taking Trileptal (oxcarbazepine tablets) as you have been told by your doctor or other health care provider, even if you feel well.
• Do not stop taking Trileptal (oxcarbazepine tablets) all of a sudden without calling your doctor. You may have a greater risk of seizures. If you need to stop this drug, you will want to slowly stop it as ordered by your doctor.

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.

What are some side effects that I need to call my doctor about right away?

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.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Very bad muscle pain or weakness.
• Very bad joint pain or swelling.
• Feeling confused.
• Not able to focus.
• Change in speech.
• Change in eyesight.
• If seizures are worse or not the same after starting Trileptal (oxcarbazepine tablets).
• Not able to control eye movements.
• Memory problems or loss.
• Trouble walking.
• Change in balance.
• Rarely, low blood cell counts have happened with Trileptal (oxcarbazepine tablets). 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.

What are some other side effects of Trileptal?

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 tired or weak.
• Upset stomach or throwing up.
• Not hungry.
• Belly pain.
• Dizziness.
• Feeling sleepy.
• Shakiness.
• Feeling nervous and excitable.
• Trouble sleeping.
• Change in taste.
• Diarrhea.
• Constipation.
• Signs of a common cold.

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 Trileptal?

• Store at room temperature.
• Keep lid tightly closed.
• 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 Trileptal (oxcarbazepine tablets) is refilled. If you have any questions about Trileptal (oxcarbazepine tablets), 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.

Frequently asked questions

• How long does Trileptal withdrawal last?
• Does Trileptal cause weight gain?
• How long does it take for Trileptal to work?
• Is Oxtellar XR the same as Trileptal?

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