DIVALPROEX SODIUM- divalproex sodium tablet, extended release 
Contract Pharmacy Services-PA



Divalproex (dye-val-PRO-ex) Sodium Extended-release Tablets

Read this Medication Guide before you start taking divalproex sodium 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?

Do not stop taking divalproex sodium without first talking to your healthcare provider.

Stopping divalproex sodium suddenly can cause serious problems.

Divalproex sodium 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 may harm your unborn baby.

Pregnancy Registry: If you become pregnant while taking divalproex sodium, 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:

4. Like other antiepileptic drugs, divalproex sodium 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 without first talking to a healthcare provider.

Stopping divalproex sodium suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that do 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 SodiumExtended-Release Tablets are a prescription medicine used:

Who should not take Divalproex sodium?

Do not take divalproex sodium if you:

What should I tell my healthcare provider before taking divalproex sodium?

Before you take divalproex sodium, 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 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?

What should I avoid while taking divalproex sodium?

What are the possible side effects of divalproex sodium?

Divalproex sodium may cause other 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 include:

These are not all of the possible side effects of divalproex sodium. 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 and all medicines out of the reach of children.

General information about the safe and effective use of divalproex sodium.

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

For more information, go to www.amneal.com or call 1-877-835-5472.

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

Active ingredient: divalproex sodium, USP

Inactive ingredients:

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

*All trademarks are property of their respective owners.

Manufactured by:

Amneal Pharmaceuticals Pvt. Ltd.

Ahmedabad, INDIA 382220

Distributed by:

Amneal Pharmaceuticals

Bridgewater, NJ 08807

Rev. 07-2015-02

Repackaged by:

Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA

Rev: Original—2017.09.21—NJW

Revised: 9/2017
Contract Pharmacy Services-PA