DIVALPROEX SODIUM- divalproex sodium tablet, film coated, extended release 
American Health Packaging

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MEDICATION GUIDE

8231001/1223(F)

Divalproex Sodium (dye val’ proe ex soe’ dee um)
Extended-Release Tablets, USP

What is the most important information I should know about divalproex sodium extended-release tablets?
Do not stop divalproex sodium extended-release tablets without first talking to your healthcare provider.
Stopping divalproex sodium extended-release tablets 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).

Divalproex sodium extended-release tablets 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:

2. Divalproex sodium extended-release tablets may harm your unborn baby.

3. Swelling (Inflammation) and bleeding (hemorrhaging) of your pancreas that can cause death.
Call your healthcare provider right away if you have any of these symptoms:

4. Like other antiepileptic drugs, divalproex sodium extended-release tablets 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:

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

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

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 divalproex sodium extended-release tablets?
divalproex sodium ER tablets are prescription medicines used:

Do not take divalproex sodium extended-release tablets if you:

Before taking divalproex sodium extended-release tablets, tell your healthcare provider about all of your medical conditions including if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Divalproex sodium extended-release tablets may affect the way other medicines work, and other medicines may affect how divalproex sodium extended-release tablets works. Using divalproex sodium extended-release tablets with other medicines can cause serious side effects. Do not start or stop other medicines without talking to your healthcare provider.

Especially tell your healthcare provider if you take:

You can 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 each time you get a new medicine

How should I take divalproex sodium extended-release tablets?

What should I avoid while taking divalproex sodium extended-release tablets?

What are the possible side effects of divalproex sodium extended-release tablets?

Call your healthcare provider right away if you have any of the symptoms listed below. Your healthcare provider may do additional tests before and during your treatment with divalproex sodium extended-release tablets. Your healthcare provider may reduce your dose, temporarily stop, or permanently stop treatment if you have certain side effects

Divalproex sodium extended-release tablets can cause serious side effects including:

bruising or red or purple spots on your skinvomiting blood or vomit that looks like coffee grounds
  • bleeding from your mouth or nose
  • blood in your stools or black stools (looks like tar)
  • cough up blood or blood clots
  • pain and swelling in your joints
feeling tireddrowsiness
  • confusion
  • coma
  • memory loss
  • shivering
feverblistering and peeling of your skin
  • skin rash
  • swelling of your lymph nodes
  • hives
  • swelling of your face, eyes, lips, tongue, or throat
  • sores in your mouth
  • trouble swallowing or breathing

Tell your healthcare provider if you have or think you may have medicine residue in your stool. The common side effects of divalproex sodium extended-release tablets include:

headacheloss of appetite
  • weakness
  • weight loss
  • sleepiness
  • increased appetite
  • dizziness
  • weight gain
  • tremors
  • nausea / vomiting
  • difficulty walking or problems with coordination
  • stomach pain
  • ringing in your ears
  • diarrhea
  • blurred vision
  • constipation
  • double vision
  • bronchitis
  • unusual eye movement
  • flu-like symptoms
  • hair loss (alopecia)
  • infection
  • swelling of your arms or legs

These are not all of the possible side effects of divalproex sodium extended-release tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088.

How should I store divalproex sodium extended-release tablets?

Keep divalproex sodium extended-release tablets and all medicines out of the reach of children.

General information about the safe and effective use of divalproex sodium extended-release tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use divalproex sodium extended-release tablets for a condition for which it was not prescribed. Do not give divalproex sodium extended-release tablets to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about divalproex sodium extended-release tablets that is written for health professionals.

What are the ingredients in divalproex sodium extended-release tablets?

Active ingredient: divalproex sodium
Inactive ingredients: hydroxypropyl cellulose, hypromellose, lecithin, magnesium stearate, polyethylene glycol, polyvinyl alcohol (partially hydrolyzed), silicon dioxide, talc, titanium dioxide and xanthan gum. Each tablet is imprinted with black pharmaceutical ink which contains: ammonium hydroxide, ferrosoferric oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac.

To order more Medication Guides call American Health Packaging at 1‐800‐707‐4621.

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

Distributed by:
American Health Packaging
Columbus, OH 43217

8231001/1223(F)

Revised: 8/2024
American Health Packaging