DIVALPROEX SODIUM- divalproex sodium capsule 
NCS HealthCare of KY, LLC dba Vangard Labs

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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?

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:

• complex partial seizures in adults and children 10 years of age and older

• simple and complex absence seizures, with or without other seizure types

Who should not take divalproex sodium delayed-release capsules?

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

• have liver problems

• have or think you have a genetic liver problem caused by a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome)

• are allergic to divalproex sodium, valproic acid, sodium valproate, or any of the ingredients in divalproex sodium delayed-release capsules. See the end of this leaflet for a complete list of ingredients in divalproex sodium delayed-release capsules.

• have a genetic problem called urea cycle disorder

• are taking it to prevent migraine headaches and are either pregnant or may become pregnant because you are not using effective birth control (contraception).

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:

• have a genetic liver problem caused by a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome)

• drink alcohol

• are pregnant or breastfeeding. Divalproex sodium can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take divalproex sodium delayed-release capsules.

• have or have had depression, mood problems, or suicidal thoughts or behavior

• have any other medical conditions

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?

• Take divalproex sodium delayed-release capsules exactly as your healthcare provider tells you. Your healthcare provider will tell you how much divalproex sodium delayed-release capsules to take and when to take it.

• Your healthcare provider may change your dose.

• Do not change your dose of divalproex sodium delayed-release capsules without talking to your healthcare provider.

• 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 may be swallowed whole, or they may be opened and the contents may be sprinkled on a small amount of soft food, such as applesauce or pudding. See the Administration Guide, for detailed instructions on how to use divalproex sodium delayed-release capsules.

• If you take too much divalproex sodium delayed-release capsules, call your healthcare provider or local Poison Control Center right away.

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

• Divalproex sodium delayed-release capsules can cause drowsiness and dizziness. Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking divalproex sodium delayed-release capsules, until you talk with your doctor. Taking divalproex sodium delayed-release capsules with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.

• Do not drive a car or operate dangerous machinery until you know how divalproex sodium delayed-release capsules affects you. Divalproex sodium delayed-release capsules can slow your thinking and motor skills.

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

• See “What is the most important information I should know about divalproex sodium delayed-release capsules?”  

Divalproex sodium delayed-release capsules can cause serious side effects including:  

• Bleeding problems: red or purple spots on your skin, bruising, pain and swelling into your joints due to bleeding or bleeding from your mouth or nose.

• High ammonia levels in your blood: feeling tired, vomiting, changes in mental status.

• Low body temperature (hypothermia): drop in your body temperature to less than 95°F, feeling tired, confusion, coma.

• Allergic (hypersensitivity) reactions: fever, skin rash, hives, sores in your mouth, blistering and peeling of your skin, swelling of your lymph nodes, swelling of your face, eyes, lips, tongue, or throat, trouble swallowing or breathing.

• Drowsiness or sleepiness in the elderly. This extreme drowsiness may cause you to eat or drink less than you normally would. Tell your doctor if you are not able to eat or drink as you normally do. Your doctor may start you at a lower dose of divalproex sodium delayed-release capsules.

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:

• nausea

• headache

• sleepiness

• vomiting

• weakness

• tremor

• dizziness

• stomach pain

• blurry vision

• double vision

• diarrhea

• increased appetite

• weight gain

• hair loss

• loss of appetite

• problems with walking or coordination

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?

• Store divalproex sodium delayed-release capsules at 20°-25°C (68°-77°F) 

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

150052079

Revised: 12/2021
NCS HealthCare of KY, LLC dba Vangard Labs