FREQUENTLY ASKED QUESTIONS

ABOUT APTIOM

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A: APTIOM is an FDA-approved prescription medicine used alone or with other medicines to treat partial-onset seizures.

It is not known if APTIOM is safe and effective in children under 18 years of age.

A: The active ingredient is eslicarbazepine acetate. Inactive ingredients are povidone, croscarmellose sodium, and magnesium stearate.

A: If you are allergic to eslicarbazepine acetate, any of the other ingredients in APTIOM, or oxcarbazepine, you should not take APTIOM. There may be other reasons. Be sure to discuss taking APTIOM with your doctor before doing so.

A: APTIOM is thought to help disrupt abnormal electrical activity in the brain that causes partial-onset seizures, although the precise way APTIOM works is not known.

TAKING APTIOM

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A: Before taking APTIOM, tell your health care provider about any and 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 oxcarbazepine. Some people who are allergic to oxcarbazepine may also be allergic to APTIOM.
  • use birth control medicine. 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.
  • are pregnant or plan to become pregnant. APTIOM may harm your unborn baby. Tell your health care provider right away if you become pregnant while taking APTIOM. You and your health care provider will decide if you should take APTIOM while you are pregnant.
    • 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.
  • are breastfeeding or plan to breastfeed. APTIOM passes into breast milk. You and your health care provider should discuss whether you should take APTIOM or breastfeed.

Tell your health care provider about any and 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
  • simvastatin
  • clobazam
  • phenytoin
  • rosuvastatin
  • carbamazepine
  • omeprazole
  • phenobarbital
  • birth control medicine
  • primidone

Ask your health care provider or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them and show it to your health care provider and pharmacist when you get a new medicine.

A: APTIOM may be taken alone, or as an add-on therapy. As an add-on therapy, it can be taken with most other anti-seizure medications used to treat partial-onset seizures. Talk to your doctor to determine if APTIOM may be right for you.

A: Your doctor will let you know the amount of APTIOM you should be taking daily. He or she may make small increases to the dose of your medicine based on your response to it. These increases may continue until you reach your maintenance dose, or the regular amount you will take daily. Always be sure to follow your doctor's instructions.

A: No. It is not known if APTIOM is safe and effective in children under 18 years of age.

A: If you are still experiencing partial-onset seizures, talk with your doctor about APTIOM as a possible treatment option. Only your doctor can determine if APTIOM may be right for you.

A: APTIOM may cause other serious problems that can affect your nervous system or liver. Symptoms of nervous system problems include:

  • dizziness
  • trouble walking or with coordination
  • feeling sleepy and tired
  • trouble concentrating
  • vision problems

Symptoms of liver problems include:

  • yellowing of your skin or the whites of your eyes
  • nausea or vomiting
  • loss of appetite
  • stomach pain
  • dark urine

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

The most common side effects of APTIOM include:

  • dizziness
  • nausea
  • double vision
  • feeling tired
  • shakiness
  • sleepiness
  • headache
  • vomiting
  • blurred vision
  • problems with coordination

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

These are not all the possible side effects of APTIOM. For more information, ask your health care provider or pharmacist.

Call your doctor for medical advice about side effects.

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.

Like other antiepileptic drugs, APTIOM may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call a health care provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

  • thoughts about suicide or dying
  • attempt to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood

How can I watch for early symptoms of suicidal thoughts and actions?

  • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
  • Keep all follow-up visits with your health care provider as scheduled.
  • Call your health care provider between visits as needed, especially if you are worried about symptoms.

Suicidal thoughts or actions may be caused by things other than medicines. If you have suicidal thoughts or actions, your health care provider may check for other causes.

Aptiom may 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 health care 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 do not go away or come and go
  • 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

A: If you are able to drive, it’s best to wait until you know how APTIOM may affect you before doing so. It is also recommended that you not operate heavy machinery or do any dangerous activities. APTIOM may slow your thinking and motor skills, so take precaution when starting this medication and always discuss driving with your doctor.

When it comes to driving, every state has different laws and regulations. To find out your state's driving regulations, click here.

A: Talk with your doctor to find out which activities are okay.

A: You should store APTIOM at 68°F to 77°F (20°C to 25°C). As with any medication, be sure to safely throw away medicine that is out of date or no longer needed, and keep it out of reach of children.

A: Make sure you take APTIOM exactly as prescribed by your doctor. It is taken once daily, whole or crushed, with or without food.

Your health care provider will tell you how much APTIOM to take, and may change your dose. Ask what you should do if you miss a dose. If you take too much APTIOM, call your health care provider or go to the nearest hospital emergency room right away.

A: Your health care provider will tell you how much APTIOM to take. You can take APTIOM whole or crushed, just make sure you take APTIOM exactly as prescribed.

Do not use APTIOM for a condition for which it was not prescribed. Do not give APTIOM to other people, even if they have the same symptoms that you have. It may harm them. For more information, call 1-844-4APTIOM (1-844-427-8466) (8 AM to 8 PM EST, Monday through Friday).

SAVINGS AND SUPPORT

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A: Samples of APTIOM are sometimes distributed to health care providers, who can determine dosage and prescribe APTIOM to their patients. Check with your doctor for samples, and ask if APTIOM may be right for you.

A: You may get prescriptions of APTIOM for as little as a $10 co-pay with the APTIOM Savings Card. Click here to find out if you’re eligible when you sign up for Sunovion Answers for APTIOM. Co-pay amounts may vary.

A: You can print a replacement card on the APTIOM Web site by clicking here or calling our customer service center at 1-844-4APTIOM (1-844-427-8466) 8 AM to 8 PM EST, Monday through Friday.

A: APTIOM is covered by a wide range of insurance companies, and Medicare and Medicaid. As there are a number of insurance companies with varying benefits, you should call your provider to understand your coverage. Some medicines, like APTIOM, may require a preauthorization from your insurance company, which generally means your insurance company might require more information from your doctor. If you go to the pharmacy and your pharmacist tells you your insurance company requires prior authorization for APTIOM, call Sunovion Answers for APTIOM at 1-844-4APTIOM (1-844-427-8466). Our reimbursement specialists will be able to assist you in initiating the Prior Authorization process.

A: When you sign up for Sunovion Answers for APTIOM, you'll also receive information on living with epilepsy, along with helpful tips and tools. You can get started by signing up here.

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