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UNDERSTANDING EPILEPSY AND SEIZURES

There’s no doubt that epilepsy is a serious medical condition, but don’t let it scare you. Millions of people have it, and you certainly are not alone, whether you’re managing your own epilepsy or caring for someone with epilepsy.

  • Between 2.2 and 3 million people in the United States have epilepsy
  • Epilepsy affects people of all ages and races
  • One in every 26 people in the United States will suffer from epilepsy at some time in his or her life
  • For more than 60% of people who have epilepsy, the cause is unknown

For helpful information about epilepsy, visit the Epilepsy Foundation® website .

What Is Epilepsy?

The International League Against Epilepsy (ILAE) describes epilepsy as a disease of the brain defined by any of the following conditions:

  • At least 2 unprovoked (not caused by a trigger) or provoked seizures occurring more than 24 hours apart
  • 1 unprovoked seizure and a probability of further seizures (at least 60%) to the general population after having 2 unprovoked seizures over the next 10 years
  • Diagnosis of an epilepsy syndrome

Epilepsy is caused by irregular brain activity and can develop at any age. Some people are born with a defect in the structure of their brain. Other people have had a head injury, tumor, stroke, or an infection causing epilepsy. Some people may not exhibit an epileptic seizure until years after experiencing the brain injury thought to have caused it.

Seizures can be grouped into 4 seizure types defined by where they begin in the brain:

  • Generalized-onset seizures: involve both sides of the brain
  • Focal seizures: start in one side of the brain
  • Unknown-onset seizures: Onset was not observed
  • Focal to bilateral seizure: a seizure that starts in one side of the brain and spreads to both sides

About 60% of people diagnosed with epilepsy have focal seizures.

One study found approximately two-thirds of seizures in children are focal seizures.

What Are Focal Seizures?

Focal seizures start in only one side of the brain and are caused by a problem in electrical signaling. Groups of neurons suddenly begin firing excessively, leading to involuntary movements, sensations, emotions, behaviors, and possible loss of consciousness. Common symptoms may include:

  • Abnormal stiffness of the arm and/or leg
  • Illusions and hallucinations
  • Déjà vu or jamais vu
  • Fear/anxiety
  • Lip smacking, chewing, or swallowing movements
  • Loss of consciousness
  • Fumbling of hands or shuffling of feet
  • Confusion following cessation of seizure

Focal seizure triggers vary from person to person. Common seizure triggers may include:

  • Missing a dose of epilepsy medication
  • Stress
  • Dehydration
  • Lack of sleep or extreme fatigue
  • Flashing bright lights (ie, from playing video games)

To identify what your own seizure triggers are, or to help identify your loved one's seizure triggers, document the events leading up to the seizures in a seizure diary.

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IMPORTANT SAFETY INFORMATION AND INDICATION FOR APTIOM (eslicarbazepine acetate):

It is not known if APTIOM is safe and effective in children under 4 years of age...[read more]

IMPORTANT SAFETY INFORMATION AND INDICATION FOR APTIOM (eslicarbazepine acetate):

It is not known if APTIOM is safe and effective in children under 4 years of age.

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

Suicidal behavior and ideation: Antiepileptic drugs, including APTIOM, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your doctor right away if you have any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempting to commit suicide; new or worse depression, anxiety, or irritability; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking (mania); or other unusual changes in behavior or mood.

Allergic reactions: APTIOM may cause serious skin rash or other serious allergic reactions that may affect organs or 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 doctor right away if you experience any of the following symptoms: swelling of the face, eyes, lips, or tongue; trouble swallowing or breathing; hives; fever, swollen glands, or sore throat that do not go away or come and go; painful sores in the mouth or around your eyes; yellowing of the skin or eyes; unusual bruising or bleeding; severe fatigue or weakness; severe muscle pain; or frequent infections or infections that do not go away.

Low salt (sodium) levels in the blood: APTIOM may cause the level of sodium in your blood to be low. Symptoms may include nausea, tiredness, lack of energy, irritability, confusion, muscle weakness or muscle spasms, or more frequent or more severe seizures. Some medicines can also cause low sodium in your blood. Be sure to tell your health care provider about all the other medicines that you are taking.

Nervous system problems: APTIOM may cause problems that can affect your nervous system, including dizziness, sleepiness, vision problems, trouble concentrating, and difficulties with coordination and balance. APTIOM may slow your thinking or motor skills. Do not drive or operate heavy machinery until you know how APTIOM affects you.

Liver problems: APTIOM may cause problems that can affect your liver. Symptoms of liver problems include yellowing of your skin or the whites of your eyes, nausea or vomiting, loss of appetite, stomach pain, or dark urine.

Most common adverse reactions: The most common side effects in patients taking APTIOM include dizziness, sleepiness, nausea, headache, double vision, vomiting, feeling tired, problems with coordination, blurred vision, and shakiness.

Drug interactions: Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking APTIOM 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 health care provider. Especially tell your health care provider if you take oxcarbazepine, carbamazepine, phenobarbital, phenytoin, primidone, clobazam, omeprazole, simvastatin, rosuvastatin, or birth control medicine.

Discontinuation: Do not stop taking APTIOM without first talking to your health care provider. Stopping APTIOM suddenly can cause serious problems.

Pregnancy and lactation: APTIOM may cause your birth control medicine to be less effective. Talk to your health care provider about the best birth control method to use. APTIOM may harm your unborn baby. APTIOM passes into breast milk. Tell your health care provider if you are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. You and your health care provider will decide if you should take APTIOM. If you become pregnant while taking APTIOM, talk to your health care 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.

Get medical help right away if you have any of the symptoms listed above.

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.

For more information, please see the APTIOM Medication Guide and Full Prescribing Information.

INDICATION:

Aptiom® (eslicarbazepine acetate) is a prescription medicine to treat partial-onset seizures in patients 4 years of age and older.