VALPROIC- valproic acid capsule, liquid filled
Actavis Pharma, Inc.
Valproic Acid (val-proé-ik-as íd) Capsules
Read this Medication Guide before you start taking Valproic Acid 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 Valproic Acid Capsules?
Do not stop taking Valproic Acid Capsules without first talking to your healthcare provider.
Stopping valproic acid suddenly can cause serious problems.
Valproic Acid 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. Valproic Acid Capsules may harm your unborn baby.
Birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors.
Taking folic acid supplements before getting pregnant and during early pregnancy can lower the chance of having a baby with a neural tube defect.
If you take Valproic Acid Capsules during pregnancy for any medical condition, your child is at risk for having a lower IQ and may be at risk for developing autism or attention deficit/hyperactivity disorder.
There may be other medicines to treat your condition that have a lower chance of causing birth defects and decreased IQ, or other disorders in your child.
Women who are pregnant must not take Valproic Acid Capsules to prevent migraine headaches.
All women of child-bearing age (including girls from the start of puberty) should talk to their healthcare provider about using other possible treatments instead of Valproic Acid Capsules. If the decision is made to use Valproic Acid Capsules, you should use effective birth control (contraception).
Tell your healthcare provider right away if you become pregnant while taking Valproic Acid Capsules. You and your healthcare provider should decide if you will continue to take Valproic Acid Capsules while you are pregnant.
Pregnancy Registry: If you become pregnant while taking Valproic Acid Capsules, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334 or by visiting the website, http://www.aedpregnancyregistry.org/. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
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, Valproic Acid 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 Valproic Acid Capsules without first talking to a healthcare provider. Stopping Valproic Acid suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that do 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 Valproic Acid Capsules?
Valproic Acid Capsules come in capsule dosage form.
Valproic Acid Capsules are a 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 or without other seizure types
Who should not take Valproic Acid Capsules?
Do not take Valproic Acid Capsules if you:
What should I tell my healthcare provider before taking Valproic Acid Capsules?
Before you take Valproic Acid Capsules, 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 Valproic Acid 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 Valproic Acid Capsules?
What should I avoid while taking Valproic Acid Capsules?
Valproic Acid Capsules can cause drowsiness and dizziness. Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking Valproic Acid Capsules, until you talk with your doctor. Taking Valproic Acid 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 Valproic Acid Capsules affect you. Valproic acid can slow your thinking and motor skills.
What are the possible side effects of Valproic Acid Capsules?
• See “What is the most important information I should know about Valproic Acid Capsules?”
Valproic Acid Capsules can cause serious side effects including:
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, skin 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 valproic acid.
Call your healthcare provider right away, if you have any of the symptoms listed above.
The common side effects of Valproic Acid Capsules include:
These are not all of the possible side effects of Valproic Acid 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 Valproic Acid Capsules?
Keep Valproic Acid Capsules and all medicines out of the reach of children.
General information about the safe and effective use of Valproic Acid Capsules
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Valproic Acid Capsules for a condition for which it was not prescribed. Do not give Valproic Acid 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 Valproic Acid Capsules. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Valproic Acid Capsules that is written for health professionals. For more information, call 1-888-838-2872.
What are the ingredients in Valproic Acid Capsules?
Active ingredient: valproic acid
Inactive ingredients: peanut oil, gelatin, glycerin, and titanium dioxide
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Catalent Pharma Solutions, LLC
2725 Scherer Drive North
St. Petersburg, FL 33716-1016
Teva Pharmaceuticals USA, Inc.
Parsippany, NJ 07054 USA
Revised: November 2020
Valproic Acid USP, 250 mg
750-08011 REV 7