DIVALPROEX SODIUM- divalproex sodium capsule 
Dr. Reddy's Laboratories Ltd

----------

MEDICATION GUIDE

Divalproex Sodium Delayed-release Capsules, USP

(dye val' proe ex soe' dee um)

Read this Medication Guide before you start taking divalproex sodium delayed-release capsules 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 delayed-release capsules? 

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

Stopping divalproex sodium delayed-release capsules suddenly can cause serious problems.

Divalproex sodium delayed-release capsules 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 delayed-release capsules 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 delayed-release capsules 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?

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 divalproex sodium delayed-release capsules without first talking to a healthcare provider.

Stopping divalproex sodium delayed-release capsules 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 delayed-release capsules?

Divalproex sodium delayed-release capsule is a prescription medicine used alone or with other medicines, to treat:

Who should not take divalproex sodium delayed-release capsules?

Do not take divalproex sodium delayed-release capsules if you:

What should I tell my healthcare provider before taking divalproex sodium delayed-release capsules?

Before you take divalproex sodium delayed-release capsules, 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 delayed-release capsules 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 delayed-release capsules?

What should I avoid while taking divalproex sodium delayed-release capsules?

What are the possible side effects of divalproex sodium delayed-release capsules?

Divalproex sodium delayed-release capsules 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 delayed-release capsules include:

These are not all of the possible side effects of divalproex sodium delayed-release capsules. 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 delayed-release capsules?

Keep divalproex sodium delayed-release capsules and all medicines out of the reach of children.  

General information about the safe and effective use of divalproex sodium delayed-release capsules

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

For more information, call 1-888-375-3784.  

What are the ingredients in divalproex sodium delayed-release capsules?:

Active ingredient: divalproex sodium  

Inactive ingredients:

Divalproex sodium delayed-release capsules: black iron oxide, D&C Red 28, ethyl cellulose, FD&C Blue 1, gelatin, hypromellose, magnesium stearate, sugar sphere, titanium dioxide, and triethyl citrate NF. 

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

To reorder additional Medication Guides, contact Dr. Reddy’s Customer Service at 1-866-733-3952. 

RX Only 

Distributed by:

Dr. Reddy’s Laboratories Inc.

Princeton, NJ 08540

Made in India

Revised: 0421

Revised: 4/2021
Dr. Reddy's Laboratories Ltd