DIVALPROEX SODIUM - divalproex sodium capsule, coated pellets 
Ajanta Pharma USA Inc.

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MEDICATION GUIDE


DIVALPROEX SODIUM DELAYED-RELEASE CAPSULES, USP (SPRINKLE)
(dye val' proe ex soe' dee um)

for oral use
125 mg

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

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).

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 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 capsules.


2. Divalproex sodium delayed-release capsules 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 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.

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 capsules are prescription medicines used:

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

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

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

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

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

obruising or red or purple spots on your skinovomiting blood or vomit that looks like coffee grounds 
obleeding from your mouth or noseoblood in your stools or black stools (looks like tar)
ocough up blood or blood clots opain and swelling in your joints

ofeeling tireddrowsiness
oconfusionocoma
omemory lossshivering

ofeveroblistering and peeling of your skin
oskin rashoswelling of your lymph nodes
o hivesoswelling of your face, eyes, lips, tongue, or throat
osores in your mouth,  otrouble swallowing or breathing

• 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 capsules.

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?

Divalproex sodium delayed-release capsules comes in a child-resistant package.

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.

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 Ajanta Pharma USA Inc. at 1-855-664-7744.

What are the ingredients in divalproex sodium delayed-release capsules?
Active ingredient: divalproex sodium, USP

Inactive ingredients:
Sugar spheres (contains sucrose and maize starch), ethylcellulose, triethyl citrate, talc, silicon dioxide, and magnesium stearate.
The capsule shells contain gelatin, FD&C Blue 1, D&C Red 28, and titanium dioxide.
Each capsule is printed with black pharmaceutical ink which contains: shellac, propylene glycol, black iron oxide and potassium hydroxide.

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

Marketed by:
Ajanta Pharma USA Inc.
Bridgewater, NJ 08807.

Made in INDIA

#All trademarks are the properties of their respective owners
Revised: 04/2024

Revised: 4/2024
Ajanta Pharma USA Inc.