DEPAKOTE- divalproex sodium tablet, delayed release 
AbbVie Inc.

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MEDICATION GUIDE

DEPAKOTE ER (dep-a-kOte)

(divalproex sodium)

Extended Release Tablets

DEPAKOTE (dep-a-kOte)

(divalproex sodium)

Tablets

DEPAKOTE (dep-a-kOte)

(divalproex sodium delayed release capsules)

Sprinkle Capsules

DEPAKENE (dep-a-keen)

(valproic acid)

Capsules and Oral Solution

Read this Medication Guide before you start taking Depakote or Depakene and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about Depakote or Depakene?

Do not stop Depakote or Depakene without first talking to your healthcare provider.

Stopping Depakote or Depakene suddenly can cause serious problems.

Depakote and Depakene can cause serious side effects, including:

  1. Serious liver damage that can cause death, especially in children younger than 2 years old.

    The risk of getting this serious liver damage is more likely to happen within the first 6 months of treatment.

    Call your healthcare provider right away if you get any of the following symptoms:
    • nausea or vomiting that does not go away
    • loss of appetite
    • pain on the right side of your stomach (abdomen)
    • dark urine
    • swelling of your face
    • yellowing of your skin or the whites of your eyes
    In some cases, liver damage may continue despite stopping the drug.
  2. Depakote or Depakene may harm your unborn baby.
    • If you take Depakote or Depakene during pregnancy for any medical condition, your baby is at risk for serious birth defects. The most common birth defects with Depakote or Depakene affect the brain and spinal cord and are called spina bifida or neural tube defects. These defects occur in 1 to 2 out of every 100 babies born to mothers who use this medicine during pregnancy. These defects can begin in the first month, even before you know you are pregnant. Other birth defects can happen.
    • Birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors.
    • Taking folic acid supplements before getting pregnant and during early pregnancy can lower the chance of having a baby with a neural tube defect.
    • If you take Depakote or Depakene during pregnancy for any medical condition, your child is at risk for having a lower IQ.
    • There may be other medicines to treat your condition that have a lower chance of causing birth defects and decreased IQ in your child.
    • Women who are pregnant must not take Depakote or Depakene to prevent migraine headaches.
    • All women of childbearing age should talk to their healthcare provider about using other possible treatments instead of Depakote or Depakene. If the decision is made to use Depakote or Depakene, you should use effective birth control (contraception).
    • Tell your healthcare provider right away if you become pregnant while taking Depakote or Depakene. You and your healthcare provider should decide if you will continue to take Depakote or Depakene while you are pregnant.
    • Pregnancy Registry: If you become pregnant while taking Depakote or Depakene, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
  3. Inflammation of your pancreas that can cause death.

    Call your healthcare provider right away if you have any of these symptoms:

    • severe stomach pain that you may also feel in your back
    • nausea or vomiting that does not go away
  4. Like other antiepileptic drugs, Depakote or Depakene 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
    • attempts 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 healthcare provider as scheduled.

    Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

    Do not stop Depakote or Depakene without first talking to a healthcare provider. Stopping Depakote or Depakene suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

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

What are Depakote and Depakene?

Depakote and Depakene come in different dosage forms with different usages.

Depakote Tablets and Depakote Extended Release Tablets are prescription medicines used:

Depakene (solution and liquid capsules) and Depakote Sprinkles are prescription medicines used alone or with other medicines, to treat:

Who should not take Depakote or Depakene?

Do not take Depakote or Depakene if you:

What should I tell my healthcare provider before taking Depakote or Depakene?

Before you take Depakote or Depakene, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, herbal supplements and medicines that you take for a short period of time.

Taking Depakote or Depakene with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine.

How should I take Depakote or Depakene?

What should I avoid while taking Depakote or Depakene?

What are the possible side effects with Depakote or Depakene?

Depakote or Depakene can cause serious side effects including:

Call your healthcare provider right away, if you have any of the symptoms listed above.

The common side effects of Depakote and Depakene include:

These are not all of the possible side effects of Depakote or Depakene. For more information, ask your healthcare provider or pharmacist.

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

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Depakote or Depakene?

Keep Depakote or Depakene and all medicines out of the reach of children.

General information about the safe and effective use of Depakote or Depakene

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Depakote or Depakene for a condition for which it was not prescribed. Do not give Depakote or Depakene 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 Depakote or Depakene. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Depakote or Depakene that is written for health professionals.

For more information, go to www.rxabbvie.com or call 1-800-633-9110.

What are the ingredients in Depakote or Depakene?

Depakote:

Active ingredient: divalproex sodium

Inactive ingredients:

Depakene:

Active ingredient: valproic acid

Inactive ingredients:

Depakote ER:

250 mg is Mfd. by AbbVie LTD, Barceloneta, PR 00617

500 mg is Mfd. by AbbVie Inc., North Chicago, IL 60064 U.S.A. or

AbbVie LTD, Barceloneta, PR 00617

For AbbVie Inc., North Chicago, IL 60064 U.S.A.

Depakote Tablets:

Mfd. by AbbVie LTD, Barceloneta, PR 00617

For AbbVie Inc., North Chicago, IL 60064, U.S.A.

Depakote Sprinkle Capsules:

AbbVie Inc., North Chicago, IL 60064, U.S.A.

Depakene Capsules:

Mfd. by Banner Pharmacaps, Inc., High Point, NC 27265 U.S.A.

For AbbVie Inc., North Chicago, IL 60064, U.S.A.

Depakene Oral Solution:

Mfd. by AbbVie Inc., North Chicago, IL 60064, U.S.A.

OR by DPT Laboratories, Ltd., San Antonio, TX 78215, U.S.A.

For AbbVie Inc., North Chicago, IL 60064, U.S.A.


This Medication Guide has been approved by the U.S. Food and Drug Administration.



03-B018 August 2014

Revised: 07/2014
 
AbbVie Inc.