DIVALPROEX SODIUM- divalproex sodium tablet, delayed release 
Lupin Pharmaceuticals, Inc.

----------

MEDICATION GUIDE

Divalproex Sodium (dye val' proe ex soe' dee um)

Delayed-Release Tablets, for oral use

Rx only

What is the most important information I should know about divalproex sodium delayed-release tablets?

Do not stop divalproex sodium delayed-release tablets without first talking to a healthcare provider.

Stopping divalproex sodium delayed-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 delayed-release tablets can cause serious side effects, including:

1. Serious liver damage that can cause death, especially in children younger than 2 years old and patients with mitochondrial disorders.

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 even though the medicine is stopped. Your healthcare provider will do blood tests to check your liver before and during treatment with divalproex sodium delayed-release tablets.

2.     Divalproex sodium delayed-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 delayed-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 delayed-release tablets?

Divalproex sodium delayed-release tablets are prescription medicines 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 other medicines to treat:

      •   patients with multiple seizure types that include absence seizures

Divalproex Sodium Delayed-Release Tablets are also used to prevent migraine headaches.

Divalproex Sodium Delayed-Release Tablets are also used to treat manic episodes associated with bipolar disorder.

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

Before taking divalproex sodium delayed-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 delayed-release tablets may affect the way other medicines work, and other medicines may affect how divalproex sodium delayed-release tablets works. Using divalproex sodium delayed-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 delayed-release tablets?

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

What are the possible side effects of divalproex sodium delayed-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 delayed-release tablets. Your healthcare provider may reduce your dose, temporarily stop, or permanently stop treatment if you have certain side effects.

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

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

The common side effects of divalproex sodium delayed-release tablets include:

•           headache
•           loss 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 delayed-release tablets.

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 tablets?

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

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

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use divalproex sodium delayed-release tablets for a condition for which it was not prescribed. Do not give divalproex sodium delayed-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 delayed-release tablets that is written for health professionals.

For more information, go to www.lupinpharmaceuticals.com or call 1-800-399-2561.

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

Active ingredient: divalproex sodium

Inactive ingredients:

Colloidal silicon dioxide, D&C Red No. 30, FD&C Blue No. 2, hydroxylpropyl cellulose, hypromellose, hypromellose phthalate, iron oxide black, iron oxide yellow, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinised starch, propylene glycol, shellac, talc, titanium dioxide and triethyl citrate.

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

®The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States. 

Manufactured by:

Lupin Limited

Goa 403 722

INDIA.

Revised: April 2023                                                                                             ID#: 273197

Revised: 1/2024
Lupin Pharmaceuticals, Inc.