DIVALPROEX SODIUM - divalproex sodium tablet, film coated, extended release 
Aphena Pharma Solutions - Tennessee, LLC

----------

MEDICATION GUIDE


Divalproex Sodium Extended-Release Tablets USP
[Divalproex (dye val PROE ex)]

Read this Medication Guide before you start taking divalproex sodium extended-release tablets 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 divalproex sodium extended-release tablets?


Do not stop taking divalproex sodium extended-release tablets without first talking to your healthcare provider.


Stopping divalproex sodium extended-release tablets suddenly can cause serious problems.


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:


In some cases, liver damage may continue despite stopping the drug.

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


3. Inflammation 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.


Do not stop divalproex sodium extended-release tablets without first talking to a 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).


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 comes in different dosage forms with different usages.


Divalproex sodium extended-release tablets are prescription medicine used:



Who should not take divalproex sodium extended-release tablets?


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



What should I tell my healthcare provider before taking divalproex sodium extended-release tablets?

Before you take divalproex sodium extended-release tablets, 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 divalproex sodium extended-release tablets 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 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?


Divalproex sodium extended-release tablets 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 divalproex sodium extended-release tablets include:


These are not all of the possible side effects of divalproex sodium extended-release tablets. 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 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. They may harm them.


This Medication Guide summarizes the most important information about divalproex sodium extended-release tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about divalproex sodium extended-release tablets that is written for health professionals.


For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.


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

Active ingredient: divalproex sodium

Inactive ingredients: FD&C Blue #1, FD&C Blue #2, hypromellose, mannitol, polyacrylate dispersion 40 percent, polyethylene glycol, pregelatinised starch (maize), propylene glycol, shellac glaze in ethanol, silicified microcrystalline cellulose, silicon dioxide, titanium dioxide, and triacetin. In addition, 500 mg tablets contain iron oxide black, iron oxide yellow, and polydextrose.

Dispense with Medication Guide available at: www.aurobindousa.com/product-medication-guides


Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road

East Windsor, NJ 08520


Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India


Revised: 04/2018

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

Revised: 10/2018
Aphena Pharma Solutions - Tennessee, LLC