"The U.S. Food and Drug Administration today approved Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epilepsy.
Epilepsy is a brain disorder caused by abnormal or excessive activity in the brain"...
Trileptal Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.
Tell your doctor right away if you have any serious side effects, including: double vision, change in vision, involuntary eye movements, difficulty speaking, difficulty concentrating, loss of coordination, trouble walking (abnormal gait), uncontrolled muscle movements (tremor), dulled sense of touch, easy bleeding/bruising, chest pain, persistent sore throat, stomach/abdominal pain, bloody stool, dark urine, change in amount of urine, yellowing of eyes/skin.
Oxcarbazepine may rarely cause very serious (possibly fatal) skin reactions. Some people in certain ethnic groups (including people of Asian/South Asian descent) are at greater risk. Your doctor may order a blood test to measure your risk before prescribing this medication. If the blood test shows you are at greater risk, discuss the risks and benefits of oxcarbazepine and other treatment choices with your doctor. Such skin reactions have developed mostly within the first few months of treatment. Get medical help right away if you develop any of the following symptoms: skin rash/blisters/peeling, itching, or swelling. Ask your doctor or pharmacist for more details.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, rash, itching/swelling (especially of the face/tongue/throat/lymph nodes), joint/muscle pain, severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Trileptal (oxcarbazepine) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking oxcarbazepine, tell your doctor or pharmacist if you are allergic to it; or to carbamazepine; or to eslicarbazepine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Tell your doctor your medical history, including: kidney disease, decreased sodium blood levels (hyponatremia), recent seizures.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor about the benefits and risks of using this medication during pregnancy. Since birth control pills, patches, implants, and injections may not work if taken with this medication (see also Drug Interactions section), discuss reliable forms of birth control with your doctor.
This medication passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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