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APTIOM- eslicarbazepine acetate tabletAPTIOM- eslicarbazepine acetate kit


  1. Patient Information
  2. Call A Healthcare Provider Right Away If You Have Any Of These Symptoms, Especially If They Are New, Worse, Or Worry You:
  3. How Can I Watch For Early Symptoms Of Suicidal Thoughts And Actions?
  4. Call Your Healthcare Provider Right Away If You Have Any Of The Following:
  5. Aptiom May Cause The Level Of Sodium In Your Blood To Be Low. Symptoms Of Low Blood Sodium Include:
  6. What Is Aptiom?
  7. Do Not Take Aptiom If You Are Allergic To Eslicarbazepine Acetate, Any Of The Other Ingredients In Aptiom, Or Oxcarbazepine. Before Taking Aptiom, Tell Your Healthcare Provider About All Your Medical Conditions, Including If You:
  8. 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 Healthcare Provider.especially Tell Your Healthcare Provider If You Take:
  9. How Should I Take Aptiom?
  10. What Should I Avoid While Taking Aptiom?
  11. What Are The Possible Side Effects Of Aptiom?
  12. Active Ingredient:
  13. Inactive Ingredients:
  14. Revised: 3/2019document Id:

Patient Information 


  • Do not stop taking APTIOM without first talking to your healthcare provider.
    • Stopping APTIOM suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy may cause seizures that will not stop (status epilepticus).
1. Like other antiepileptic drugs, APTIOM may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call A Healthcare Provider Right Away If You Have Any Of These Symptoms, Especially If They Are New, Worse, Or Worry You: 

  • thoughts about suicide or dying
  • new or worse depression
  • feeling agitated or restless
  • trouble sleeping (insomnia)
  • acting aggressive, being angry, or violent
  • an extreme increase in activity and talking (mania)
  • attempt to commit suicide
  • new or worse anxiety
  • panic attacks
  • new or worse irritability
  • acting on dangerous impulses
  • 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 healthcare provider as scheduled.
  • Call your healthcare 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 healthcare provider may check for other causes.
2. 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 Healthcare Provider Right Away If You Have Any Of The Following: 

  • swelling of your face, eyes, lips, or tongue
  • a skin rash
  • fever, swollen glands, or sore throat that do not go away or come and go
  • yellowing of your skin or eyes
  • severe fatigue or weakness
  • frequent infections or infections that do not go away
  • trouble swallowing or breathing
  • hives
  • painful sores in the mouth or around your eyes
  • unusual bruising or bleeding
  • severe muscle pain

Aptiom May Cause The Level Of Sodium In Your Blood To Be Low. Symptoms Of Low Blood Sodium Include: 


  • nausea
  • irritability
  • muscle weakness or muscle spasms
  • tiredness, lack of energy
  • confusion
  • more frequent or more severe seizures
Some medicines can also cause low sodium in your blood. Be sure to tell your healthcare provider about all the other medicines that you are taking.

What Is Aptiom? 


APTIOM is a prescription medicine used to treat partial-onset seizures.
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. Before Taking Aptiom, Tell Your Healthcare Provider About All Your Medical Conditions, Including If You: 


  • have or have had suicidal thoughts or actions, depression or mood problems
  • have liver, kidney, or blood 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 healthcare provider about the best birth control method to use.
  • are pregnant or plan to become pregnant. APTIOM may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking APTIOM. You and your healthcare provider will decide if you should take APTIOM while you are pregnant.
    • If you become pregnant while taking APTIOM, talk to your healthcare 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 healthcare provider should discuss whether you should take APTIOM or breastfeed.
Tell your healthcare 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 Healthcare Provider.especially Tell Your Healthcare Provider If You Take: 

  • oxcarbazepine
  • phenobarbital
  • carbamazepine
  • phenytoin
  • simvastatin
  • birth control medicine

  • omeprazole
  • rosuvastatin
  • clobazam
  • primidone
Ask your healthcare 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 healthcare provider and pharmacist when you get a new medicine.

How Should I Take Aptiom? 


  • Take APTIOM exactly as your healthcare provider tells you to take it.
  • Do not stop taking APTIOM without talking to your healthcare provider. Stopping APTIOM suddenly can cause serious problems, including seizures that will not stop (status epilepticus).
  • Your healthcare provider may change your dose.
  • Your healthcare provider will tell you how much APTIOM to take.
  • APTIOM can be taken with or without food.
  • APTIOM can be taken as a whole tablet or crushed.
  • If you take too much APTIOM, call your healthcare provider or go to the nearest hospital emergency room right away.
  • Talk with your healthcare provider about what you should do if you miss a dose.

What Should I Avoid While Taking Aptiom? 


  • Do not drive, operate heavy machinery, or do dangerous activities until you know how APTIOM affects you. APTIOM may slow your thinking and motor skills.

What Are The Possible Side Effects Of Aptiom? 



  • Store APTIOM at 68oF to 77oF (20oC to 25oC).
  • Safely throw away medicine that is out of date or no longer needed.
Keep APTIOM and all medicines out of reach of children.

Active Ingredient: 

eslicarbazepine acetate

Inactive Ingredients: 

croscarmellose sodium, magnesium stearate, and povidoneGeneral information about the safe and effective use of APTIOM.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. 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.
This Medication Guide summarizes the most important information about APTIOM. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about APTIOM that is written for health professionals.
For more information, go towww.aptiom.comor call 1-888-394-7377.sunovion
Manufactured for: Sunovion Pharmaceuticals Inc., Marlborough, MA 01752 USA
Under license from Bial
2017 Sunovion Pharmaceuticals Inc. All rights reserved.

PRINCIPAL DISPLAY PANEL 200 MG 30 COUNT OBLONG BOTTLE

NDC 63402-202-30

30 Tablets

ONCE DAILY

Aptiom

(eslicarbazepine acetate) Tablets

200 mg

Rx Only

ATTENTION DISPENSER: Each time Aptiom is
dispensed give the patient the accompanying
Medication Guide.

SUNOVION

Under license from Bial

PRINCIPAL DISPLAY PANEL     200 MG 30 COUNT OBLONG BOTTLE

PRINCIPAL DISPLAY PANEL 400 MG 30 COUNT OBLONG BOTTLE

NDC 63402-204-30

30 Tablets

ONCE DAILY

Aptiom

(eslicarbazepine acetate) Tablets

400 mg

Rx Only

ATTENTION DISPENSER: Each time Aptiom is
dispensed give the patient the accompanying
Medication Guide.

SUNOVION

Under license from Bial

PRINCIPAL DISPLAY PANEL     400 MG 30 COUNT OBLONG BOTTLE

PRINCIPAL DISPLAY PANEL 600 MG 60 COUNT OBLONG BOTTLE

NDC 63402-206-60

60 Tablets

ONCE DAILY

Aptiom

(eslicarbazepine acetate) Tablets

600 mg

Rx Only

ATTENTION DISPENSER: Each time Aptiom is
dispensed give the patient the accompanying
Medication Guide.

SUNOVION

Under license from Bial

PRINCIPAL DISPLAY PANEL     600 MG 60 COUNT OBLONG BOTTLE

PRINCIPAL DISPLAY PANEL 800 MG 30 COUNT OBLONG BOTTLE

NDC 63402-208-30

30 Tablets

ONCE DAILY

Aptiom

(eslicarbazepine acetate) Tablets

800 mg

Rx Only

ATTENTION DISPENSER: Each time Aptiom is
dispensed give the patient the accompanying
Medication Guide.

SUNOVION

Under license from Bial

PRINCIPAL DISPLAY PANEL     800 MG 30 COUNT OBLONG BOTTLE

PRINCIPAL DISPLAY PANEL 200 MG SAMPLE WALLET

200 mg

per tablet

NDC 63402-202-07

ONCE DAILY

Aptiom

(eslicarbazepine acetate) Tablets

200 mg

Rx Only

ATTENTION DISPENSER: Dispense the enclosed

Medication Guide to each patient.

This package contains 7 tablets.

Professional Sample

Not for Sale or Reimbursement

PRINCIPAL DISPLAY PANEL     200 MG SAMPLE WALLET

PRINCIPAL DISPLAY PANEL 400 MG SAMPLE WALLET

400 mg

per tablet

NDC 63402-204-07

ONCE DAILY

Aptiom

(eslicarbazepine acetate) Tablets

400 mg

Rx Only

ATTENTION DISPENSER: Dispense the enclosed

Medication Guide to each patient.

This package contains 7 tablets.

Professional Sample

Not for Sale or Reimbursement

PRINCIPAL DISPLAY PANEL     400 MG SAMPLE WALLET

______________________________________________________________________________

PRINCIPAL DISPLAY PANEL 600 MG SAMPLE WALLET

600 mg

per tablet

NDC 63402-206-07

ONCE DAILY

Aptiom

(eslicarbazepine acetate) Tablets

600 mg

Rx Only

ATTENTION DISPENSER: Dispense the enclosed

Medication Guide to each patient.

This package contains 7 tablets.

Professional Sample

Not for Sale or Reimbursement

PRINCIPAL DISPLAY PANEL     600 MG SAMPLE WALLET

______________________________________________________________________________

PRINCIPAL DISPLAY PANEL 800 MG SAMPLE WALLET

800 mg

per tablet

NDC 63402-208-07

ONCE DAILY

Aptiom

(eslicarbazepine acetate) Tablets

800 mg

Rx Only

ATTENTION DISPENSER: Dispense the enclosed

Medication Guide to each patient.

This package contains 7 tablets.

Professional Sample

Not for Sale or Reimbursement

PRINCIPAL DISPLAY PANEL     800 MG SAMPLE WALLET

______________________________________________________________________________

PRINCIPAL DISPLAY PANEL TITRATION SAMPLE PACK WALLET

400 mg

per tablet and

800 mg

per tablet

Titration Sample Pack

NDC 63402-248-14

ONCE DAILY

Aptiom

(eslicarbazepine acetate) Tablets

400 mg and 800 mg

Rx Only

ATTENTION DISPENSER: Dispense the enclosed

Medication Guide to each patient.

This package contains 14 tablets (7 tablets of 400 mg

and 7 tablets of 800 mg).

Professional Sample

Not for Sale or Reimbursement

PRINCIPAL DISPLAY PANEL     TITRATION SAMPLE PACK WALLET

PRINCIPAL DISPLAY PANEL 200 MG SAMPLE CARTON

NDC 63402-202-28

ONCE DAILY

Aptiom

(eslicarbazepine acetate) Tablets

200 mg

ATTENTION DISPENSER: Dispense an enclosed

Medication Guide to each patient.

Rx Only

This package contains 28 tablets on 4 sample cards.

Each sample card contains 7 tablets each.

Please see the enclosed full Prescribing Information.

200 mg

per tablet

Professional Samples

Not for Sale or

Reimbursement

PRINCIPAL DISPLAY PANEL     200 MG SAMPLE CARTON

PRINCIPAL DISPLAY PANEL 400 MG SAMPLE CARTON

NDC 63402-204-28

ONCE DAILY

Aptiom

(eslicarbazepine acetate) Tablets

400 mg

ATTENTION DISPENSER: Dispense an enclosed

Medication Guide to each patient.

Rx Only

This package contains 28 tablets on 4 sample cards.

Each sample card contains 7 tablets each.

Please see the enclosed full Prescribing Information.

400 mg

per tablet

Professional Samples

Not for Sale or

Reimbursement

PRINCIPAL DISPLAY PANEL     400 MG SAMPLE CARTON

______________________________________________________________________________

PRINCIPAL DISPLAY PANEL 600 MG SAMPLE CARTON

NDC 63402-206-28

ONCE DAILY

Aptiom

(eslicarbazepine acetate) Tablets

600 mg

ATTENTION DISPENSER: Dispense an enclosed

Medication Guide to each patient.

Rx Only

This package contains 28 tablets on 4 sample cards.

Each sample card contains 7 tablets each.

Please see the enclosed full Prescribing Information.

600 mg

per tablet

Professional Samples

Not for Sale or

Reimbursement

PRINCIPAL DISPLAY PANEL     600 MG SAMPLE CARTON

______________________________________________________________________________

PRINCIPAL DISPLAY PANEL 800 MG SAMPLE CARTON

NDC 63402-208-28

ONCE DAILY

Aptiom

(eslicarbazepine acetate) Tablets

800 mg

ATTENTION DISPENSER: Dispense an enclosed

Medication Guide to each patient.

Rx Only

This package contains 28 tablets on 4 sample cards.

Each sample card contains 7 tablets each.

Please see the enclosed full Prescribing Information.

800 mg

per tablet

Professional Samples

Not for Sale or

Reimbursement

PRINCIPAL DISPLAY PANEL     800 MG SAMPLE CARTON

______________________________________________________________________________

PRINCIPAL DISPLAY PANEL TITRATION SAMPLE PACK CARTON

NDC 63402-248-56

ONCE DAILY

Aptiom

(eslicarbazepine acetate) Tablets

400 mg and 800 mg

ATTENTION DISPENSER: Dispense an enclosed

Medication Guide to each patient.

Rx Only

This package contains 56 tablets in 4 titration sample packs.

Each titration sample pack contains 14 tablets

(7 tablets of 400 mg and 7 tablets of 800 mg).

Please see the enclosed full Prescribing Information.

400 mg

per tablet and

800 mg

per tablet

Titration Sample Pack

Professional Samples

Not for Sale or

Reimbursement

PRINCIPAL DISPLAY PANEL     TITRATION SAMPLE PACK CARTON

______________________________________________________________________________

APTIOM
eslicarbazepine acetate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63402-202
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESLICARBAZEPINE ACETATE(UNII: BEA68ZVB2K) (ESLICARBAZEPINE - UNII:S5VXA428R4)ESLICARBAZEPINE ACETATE200 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30(UNII: U725QWY32X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Colorwhite (white)Score2 pieces
ShapeOVAL (OVAL)Size11mm
FlavorImprint CodeESL;200
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63402-202-3030 in 1 BOTTLE; Type 0: Not a Combination Product04/07/2014
2NDC:63402-202-284 in 1 CARTON09/13/2017
2NDC:63402-202-077 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02241604/07/2014
APTIOM
eslicarbazepine acetate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63402-204
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESLICARBAZEPINE ACETATE(UNII: BEA68ZVB2K) (ESLICARBAZEPINE - UNII:S5VXA428R4)ESLICARBAZEPINE ACETATE400 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30(UNII: U725QWY32X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Colorwhite (white)Scoreno score
ShapeROUND (ROUND)Size11mm
FlavorImprint CodeESL;400
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63402-204-3030 in 1 BOTTLE; Type 0: Not a Combination Product04/07/2014
2NDC:63402-204-284 in 1 CARTON04/07/2014
2NDC:63402-204-077 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02241604/07/2014
APTIOM
eslicarbazepine acetate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63402-206
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESLICARBAZEPINE ACETATE(UNII: BEA68ZVB2K) (ESLICARBAZEPINE - UNII:S5VXA428R4)ESLICARBAZEPINE ACETATE600 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30(UNII: U725QWY32X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Colorwhite (white)Score2 pieces
ShapeOVAL (OVAL)Size17mm
FlavorImprint CodeESL;600
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63402-206-6060 in 1 BOTTLE; Type 0: Not a Combination Product04/07/2014
2NDC:63402-206-284 in 1 CARTON04/07/2014
2NDC:63402-206-077 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02241604/07/2014
APTIOM
eslicarbazepine acetate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63402-208
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESLICARBAZEPINE ACETATE(UNII: BEA68ZVB2K) (ESLICARBAZEPINE - UNII:S5VXA428R4)ESLICARBAZEPINE ACETATE800 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30(UNII: U725QWY32X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Colorwhite (white)Score2 pieces
ShapeOVAL (OVAL)Size19mm
FlavorImprint CodeESL;800
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63402-208-3030 in 1 BOTTLE; Type 0: Not a Combination Product04/07/2014
2NDC:63402-208-284 in 1 CARTON04/07/2014
2NDC:63402-208-077 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02241604/07/2014
APTIOM
eslicarbazepine acetate kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63402-248
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63402-248-564 in 1 CARTON04/07/2014
1NDC:63402-248-141 in 1 BLISTER PACK; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK7
Part 21 BLISTER PACK7
Part 1 of 2
APTIOM
eslicarbazepine acetate tablet
Product Information
Item Code (Source)NDC:63402-204
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESLICARBAZEPINE ACETATE(UNII: BEA68ZVB2K) (ESLICARBAZEPINE - UNII:S5VXA428R4)ESLICARBAZEPINE ACETATE400 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30(UNII: U725QWY32X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Colorwhite (white)Scoreno score
ShapeROUND (ROUND)Size11mm
FlavorImprint CodeESL;400
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63402-204-177 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02241604/07/2014
Part 2 of 2
APTIOM
eslicarbazepine acetate tablet
Product Information
Item Code (Source)NDC:63402-208
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESLICARBAZEPINE ACETATE(UNII: BEA68ZVB2K) (ESLICARBAZEPINE - UNII:S5VXA428R4)ESLICARBAZEPINE ACETATE800 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30(UNII: U725QWY32X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Colorwhite (white)Score2 pieces
ShapeOVAL (OVAL)Size19mm
FlavorImprint CodeESL;800
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63402-208-177 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02241604/07/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02241604/07/2014
Labeler -Sunovion Pharmaceuticals Inc. (131661746)

Revised: 3/2019document Id: 

05e586b4-1a22-4825-90e8-21053a1b570aSet id: 3d0c9554-eaeb-4694-8089-00133fcadce3Version: 13Effective Time: 20190328Sunovion Pharmaceuticals Inc.



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