DIVALPROEX SODIUM- divalproex sodium tablet, delayed release 
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Divalproex Sodium

(dye val PRO ex sew dee uhm)

Delayed-release Tablets, USP

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 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:

In some cases, liver damage may continue despite stopping the drug.

2.  Divalproex sodium 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 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 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?

Divalproex sodium delayed-release tablets are prescription medicines used:

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

       •      simple and complex absence seizures, with or without other seizure types to prevent migraine headaches

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 with divalproex sodium?

Divalproex sodium 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 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 delayed-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.

Please address medical inquiries to, ( MedicalAffairs@zydususa.com) Tel.: 1-877-993-8779.

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

Active ingredient: divalproex sodium, USP

Inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, methacrylic acid copolymer dispersion, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, starch (botanical source: maize),  talc and triethyl citrate. Each tablet is imprinted with black pharmaceutical ink which contains following inactive ingredients: ammonium hydroxide, ferrosoferric oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac.

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

The product's labeling may have been updated. For latest package insert, please visit www.zydususa.com

Revised: 9/2017
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