IMPORTANT SAFETY INFORMATION AND INDICATION FOR APTIOM (eslicarbazepine acetate):
Do not take APTIOM if you are allergic to eslicarbazepine acetate, any of the other ingredients in APTIOM, or oxcarbazepine... [read more]
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
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
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
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.
Aptiom® (eslicarbazepine acetate) is a prescription medicine used alone or with other medicines to treat partial-onset seizures.
For more information, please see the APTIOM Medication Guide and Full Prescribing Information.