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.
