IMPORTANT SAFETY INFORMATION

Do not take Oxtellar XR if you are allergic to oxcarbazepine, or any of the other ingredients in Oxtellar XR, or to eslicarbazepine acetate.

Oxtellar XR can cause serious side effects, including a low level of sodium in your blood. Symptoms of low blood sodium include nausea, tiredness, lack of energy, headache, confusion, and more frequent or more severe seizures. Similar symptoms that are not related to low sodium may occur from taking Oxtellar XR.

The most common side effects include dizziness, sleepiness, headache, balance problems, tremors, vomiting, double vision, and weakness. These are not all of the possible side effects of Oxtellar XR. For more information, ask your healthcare provider or pharmacist.

Like other antiepileptic drugs, Oxtellar XR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Before you take Oxtellar XR, tell your healthcare provider if you have or have had depression, mood problems, or suicidal thoughts or behavior. Call a healthcare provider right away if you have thoughts about suicide or dying, attempts to commit suicide, have new or worse depression or new or worse anxiety, feel agitated or restless, experience panic attacks, trouble sleeping (insomnia), or new or worse irritability, feel or act more aggressive, angry, or violent, act on dangerous impulses, have an extreme increase in activity and talking (mania), or experience other unusual changes in behavior or mood.

Oxtellar XR may also 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, trouble swallowing or breathing, a skin rash, hives, fever, swollen glands, or sore throat that does not go away or comes and goes, painful sores in the mouth or around your eyes, yellowing of your skin or eyes, unusual bruising or bleeding, severe fatigue or weakness, severe muscle pain, frequent infections, or infections that do not go away. Many people who are allergic to carbamazepine are also allergic to Oxtellar XR. Tell your healthcare provider if you are allergic to carbamazepine.

Before taking Oxtellar XR, tell your healthcare provider about all your medical conditions, including if you have or have had suicidal thoughts or actions, have depression or mood problems, have liver problems, have kidney problems, are allergic to carbamazepine, use birth control medicine, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Oxtellar XR passes into breast milk. Talk with your healthcare provider about the best way to feed your baby if you take Oxtellar XR.

Oxtellar XR may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Oxtellar XR. If you use birth control medicine, Oxtellar XR may cause your birth control medicine to be less effective.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking Oxtellar XR 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: carbamazepine, phenobarbital, phenytoin, or birth control medicine.

Do not stop taking Oxtellar XR without talking to your healthcare provider. Stopping Oxtellar XR suddenly can cause serious problems, including seizures that will not stop. Take Oxtellar XR exactly as prescribed.

INDICATION

Oxtellar XR® (oxcarbazepine) extended-release tablets is a prescription medicine used to treat partial-onset seizures in adults and children 6 years of age and older.

Please refer to the full Prescribing Information and Medication Guide for additional important information on Oxtellar XR.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
 

ABOUT OXTELLAR XR

FREQUENTLY ASKED QUESTIONS

ABOUT OXTELLAR XR

Oxtellar XR is a prescription seizure medication used to treat partial-onset seizures in adults and children 6 years of age and older. Oxtellar XR is not for use in children under 6 years of age.

Oxtellar XR is a once-a-day formulation of oxcarbazepine. As a commercially insured patient taking Oxtellar XR, you have access to a co-pay savings card that may reduce your co-pay to $0 per month.* Eligible patients may qualify for 12 months of therapy, renewable annually. Visit Patient Savings for more information.

*Terms and conditions apply.

Before taking Oxtellar XR, tell your doctor about all your medical conditions, including if you:

  • have or have had suicidal thoughts or actions, depression or mood problems.
  • have liver problems.
  • have kidney problems.
  • are allergic to carbamazepine. Many people who are allergic to carbamazepine are also allergic to Oxtellar XR.
  • use birth control medicine. Oxtellar XR 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. Oxtellar XR may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Oxtellar XR. You and your healthcare provider will decide if you should take Oxtellar XR while you are pregnant.
    • If you become pregnant while taking Oxtellar XR, 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. Oxtellar XR passes into breast milk. Talk with your healthcare provider about the best way to feed your baby if you take Oxtellar XR.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking Oxtellar XR 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: carbamazepine, phenobarbital, phenytoin, or birth control medicine.

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.

Do not take Oxtellar XR if you are allergic to oxcarbazepine, or any of the other ingredients in Oxtellar XR, or to eslicarbazepine acetate. See the Patient Medication Guide for a complete list of Oxtellar XR ingredients.

The most common side effects of Oxtellar XR include:

  • dizziness
  • sleepiness
  • headache
  • balance problems
  • tremors
  • vomiting
  • double vision
  • weakness or lack of energy (asthenia)

These are not all the possible side effects of Oxtellar XR. For more information about the side effects of Oxtellar XR, please see the Patient Medication Guide for a complete listing of the possible side effects of Oxtellar XR.

You can also discuss the possible side effects of Oxtellar XR with your doctor or pharmacist.

Tell your doctor if you have any Oxtellar XR side effect that bothers you or does not go away.

Call your doctor for medical advice about Oxtellar XR side effects. You may report side effects to FDA at 1-800-FDA-1088.

For more information about Oxtellar XR, you can talk to your doctor or pharmacist, or call Supernus Support toll free at 1-866-398-0833, Monday through Friday, 8 AM to 8 PM ET, excluding holidays.

TAKING OXTELLAR XR

Take Oxtellar XR 1 time each day as directed by your doctor.

It is very important to remember that in order for Oxtellar XR to work properly, you must take Oxtellar XR at the same time each day on an empty stomach.

  • Oxtellar XR should be taken at least 1 hour before or at least 2 hours after a meal.
  • Do not cut, crush, or chew the tablets before swallowing.

Do not stop taking Oxtellar XR without talking to your doctor. Stopping Oxtellar XR suddenly can cause serious problems, including partial seizures that will not stop (status epilepticus). Take Oxtellar XR exactly as prescribed. Your doctor may change your dose. Your doctor will tell you how much Oxtellar XR to take.

Tell your doctor if you have any side effect that bothers you or does not go away.

Take Oxtellar XR on an empty stomach. This means you should take Oxtellar XR at least 1 hour before or at least 2 hours after a meal. Take Oxtellar XR tablets whole with water or other liquid.

If you take too much Oxtellar XR, call your doctor or call the poison control center at 1-800-222-1222.

Talk with your doctor about what you should do if you miss a dose.

/co-pay-savings-program

Co-pay savings card

/assets/OxtellarXRPatientTalkTrackForm.pdf

Patient/Doctor
Conversation Guide

IMPORTANT SAFETY INFORMATION

Do not take Oxtellar XR if you are allergic to oxcarbazepine, or any of the other ingredients in Oxtellar XR, or to eslicarbazepine acetate.

Oxtellar XR can cause serious side effects, including a low level of sodium in your blood. Symptoms of low blood sodium include nausea, tiredness, lack of energy, headache, confusion, and more frequent or more severe seizures. Similar symptoms that are not related to low sodium may occur from taking Oxtellar XR.

The most common side effects include dizziness, sleepiness, headache, balance problems, tremors, vomiting, double vision, and weakness. These are not all of the possible side effects of Oxtellar XR. For more information, ask your healthcare provider or pharmacist.

Like other antiepileptic drugs, Oxtellar XR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Before you take Oxtellar XR, tell your healthcare provider if you have or have had depression, mood problems, or suicidal thoughts or behavior. Call a healthcare provider right away if you have thoughts about suicide or dying, attempts to commit suicide, have new or worse depression or new or worse anxiety, feel agitated or restless, experience panic attacks, trouble sleeping (insomnia), or new or worse irritability, feel or act more aggressive, angry, or violent, act on dangerous impulses, have an extreme increase in activity and talking (mania), or experience other unusual changes in behavior or mood.

Oxtellar XR may also 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, trouble swallowing or breathing, a skin rash, hives, fever, swollen glands, or sore throat that does not go away or comes and goes, painful sores in the mouth or around your eyes, yellowing of your skin or eyes, unusual bruising or bleeding, severe fatigue or weakness, severe muscle pain, frequent infections, or infections that do not go away. Many people who are allergic to carbamazepine are also allergic to Oxtellar XR. Tell your healthcare provider if you are allergic to carbamazepine.

Before taking Oxtellar XR, tell your healthcare provider about all your medical conditions, including if you have or have had suicidal thoughts or actions, have depression or mood problems, have liver problems, have kidney problems, are allergic to carbamazepine, use birth control medicine, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Oxtellar XR passes into breast milk. Talk with your healthcare provider about the best way to feed your baby if you take Oxtellar XR.

Oxtellar XR may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Oxtellar XR. If you use birth control medicine, Oxtellar XR may cause your birth control medicine to be less effective.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking Oxtellar XR 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: carbamazepine, phenobarbital, phenytoin, or birth control medicine.

Do not stop taking Oxtellar XR without talking to your healthcare provider. Stopping Oxtellar XR suddenly can cause serious problems, including seizures that will not stop. Take Oxtellar XR exactly as prescribed.

INDICATION

Oxtellar XR® (oxcarbazepine) extended-release tablets is a prescription medicine used to treat partial-onset seizures in adults and children 6 years of age and older.

Please refer to the full Prescribing Information and Medication Guide for additional important information on Oxtellar XR.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.