DIVALPROEX SODIUM- divalproex sodium tablet, delayed release
NuCare Pharmaceuticals,Inc.
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Dispense with Medication Guide available at: https://www.sunpharma.com/usa/products
MEDICATION GUIDE
Divalproex Sodium
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What is the most important information I should know about divalproex sodium delayed-release tablets?
Do not stop taking 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.
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: o thoughts about suicide or dying
How can I watch for early symptoms of suicidal thoughts and actions? o Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.
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:
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:
• have liver problems
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Before taking divalproex sodium delayed-release tablets, tell your healthcare provider about all of your medical conditions including if you:
• have or have had liver problems.
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 work. 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?
• Divalproex sodium comes in different dosage forms. • Take divalproex sodium delayed-release tablets exactly as your healthcare provider tells you. Your healthcare provider will tell you how many divalproex sodium delayed-release tablets to take and when to take it. • Your healthcare provider may change your dose, if needed. • Do not change your dose of divalproex sodium delayed-release tablets without talking to your healthcare provider. • Do not stop taking divalproex sodium delayed-release tablets without first talking to your healthcare provider.Stopping divalproex sodium delayed-release tablets suddenly can cause serious problems. • Swallow divalproex sodium delayed-release tablets whole. Do not crush or chew divalproex sodium delayed-release tablets. Tell your healthcare provider if you cannot swallow divalproex sodium delayed-release tablets whole. You may need a different medicine. • If you miss a dose of divalproex sodium delayed-release tablets, take it as soon as you remember unless it's almost time for your next dose. Take the next dose at your regular time. Do not take 2 doses at the same time. • If you take too many divalproex sodium delayed-release tablets, call your healthcare provider or poison control center right away. |
What should I avoid while taking divalproex sodium delayed-release tablets?
• Do notdrink alcohol while taking divalproex sodium delayed-release tablets. Divalproex sodium delayed-release tablets and alcohol can affect each other causing side effects such as sleepiness and dizziness. • Do not drive a car, operate dangerous machinery, or do dangerous activities until you know how divalproex sodium delayed-release tablets affect you. Divalproex sodium delayed-release tablets can slow your thinking and motor skills and may affect your vision. |
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.
o bruising or red or purple spots on your skin o vomiting blood or vomit that looks like coffee grounds
o blood in your stools or black stools (looks like tar)
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increased ammonia levels in your blood.High ammonia levels can seriously affect your mental activities, slow your alertness, make you feel tired, or cause vomiting (encephalopathy). This has happened when divalproex sodium delayed-release tablets is taken alone or with a medicine called topiramate. Call your health care provider if you have any of these symptoms.
o feeling tired o drowsiness
o coma
o shivering • severe multiorgan reactions.Treatment with divalproex sodium delayed-release tablets may cause severe multiorgan reactions that can be life-threatening or may lead to death. Stop taking divalproex sodium delayed-release tablets, and contact your healthcare provider or get medical help right away if you develop any of these symptoms of a severe skin reaction: o fever o blistering and peeling of your skin
o swelling of your lymph nodes
o swelling of your face, eyes, lips, tongue, or throat
o 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 healthcare provider if you are not able to eat or drink as you normally do. Your healthcare provider may start you at a lower dose of divalproex sodium delayed-release tablets.
The common side effects of divalproex sodium delayed-release tablets include: • headache • loss of appetite
• weight loss
• increased appetite
• weight gain
• nausea / vomiting
• stomach pain
• diarrhea
• constipation
• bronchitis
• flu-like symptoms
• infection
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?
•Store divalproex sodium delayed-release tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30° C (59° to 86° F). •Divalproex sodium delayed-release tablets comes in a child-resistant package. 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. |
What are the ingredients in divalproex sodium delayed-release tablets?
Active ingredient: divalproex sodium Inactive ingredients: Divalproex sodium delayed-release tablets:colloidal silicon dioxide, corn starch, povidone, pregelatinized maize starch, hypromellose, titanium dioxide, triacetin, methacrylic acid copolymer type C, talc, triethyl citrate, colloidal anhydrous silica, sodium bicarbonate, and sodium lauryl sulfate. Imprinting ink contains shellac glaze, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide. Individual tablets also contain: 125 mg tablets: FD&C Red #40, and FD&C Blue #2
This Medication Guide has been approved by the U.S. Food and Drug Administration. * All trademarks are the property of their respective owners. Dispense with Medication Guide available at: https://www.sunpharma.com/usa/products For more information, call 1-800-818-4555. Distributed by:
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This Medication Guide has been approved by the U.S. Food and Drug Administration Revised. 05/2023