OXCARBAZEPINE- oxcarbazepine tablet, film coated 
American Health Packaging

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MEDICATION GUIDE

8284501/0119

Oxcarbazepine Tablets, USP
(ox kar baz' e peen)
film-coated tablets, for oral use

Oxcarbazepine Tablets, USP contains FD&C yellow no. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C yellow no. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Read this Medication Guide before you start taking oxcarbazepine tablets 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 oxcarbazepine tablets?
Do not stop taking oxcarbazepine tablets without first talking to your healthcare provider.
Stopping oxcarbazepine tablets suddenly can cause serious problems.
Oxcarbazepine tablets can cause serious side effects, including:

1. Oxcarbazepine tablets may cause the level of sodium in your blood to be low. Symptoms of low blood sodium include:

Similar symptoms that are not related to low sodium may occur from taking oxcarbazepine tablets. You should tell your healthcare provider if you have any of these side effects and if they bother you or they do not go away.

Some other medicines can also cause low sodium in your blood. Be sure to tell your healthcare provider about all the other medicines that you are taking.

Your healthcare provider may do blood tests to check your sodium levels during your treatment with oxcarbazepine tablets.

2. Oxcarbazepine tablets may also cause allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions.
Call your healthcare provider right away if you have any of the following:

Many people who are allergic to carbamazepine are also allergic to oxcarbazepine tablets. Tell your healthcare provider if you are allergic to carbamazepine.

3. Like other antiepileptic drugs, oxcarbazepine 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?

Do not stop taking oxcarbazepine tablets without first talking to a healthcare provider.

Suicidal thoughts or actions may be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

What are oxcarbazepine tablets?
Oxcarbazepine tablets are a prescription medicine used:

It is not known if oxcarbazepine tablets is safe and effective for use alone to treat partial seizures in children less than 4 years of age or for use with other medicines to treat partial seizures in children less than 2 years of age.

Do not take oxcarbazepine tablets if you are allergic to oxcarbazepine tablets or any of the other ingredients in oxcarbazepine tablets or to eslicarbazepine acetate. See the end of this Medication Guide for a complete list of ingredients in oxcarbazepine tablets.

Many people who are allergic to carbamazepine are also allergic to oxcarbazepine tablets. Tell your healthcare provider if you are allergic to carbamazepine.

Before taking oxcarbazepine tablets, tell your healthcare provider about all 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. Taking oxcarbazepine tablets with certain other medicines may 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 when you get a new medicine.

How should I take Oxcarbazepine tablets?

What should I avoid while taking Oxcarbazepine tablets?

What are the possible side effects of oxcarbazepine tablets?
See "What is the most important information I should know about oxcarbazepine tablets?"
Oxcarbazepine tablets may cause other serious side effects including:

Get medical help right away if you have any of the symptoms listed above or listed in "What is the most important information I should know about oxcarbazepine tablets?"

1. The most common side effects of oxcarbazepine tablets include:

These are not all the possible side effects of oxcarbazepine tablets. Tell your healthcare provider if you have any side effect that bothers you or 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 oxcarbazepine tablets?

Keep oxcarbazepine tablets and all medicines out of the reach of children.

General Information about the safe and effective use of oxcarbazepine tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use oxcarbazepine tablets for a condition for which it was not prescribed. Do not give oxcarbazepine 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 oxcarbazepine tablets that is written for health professionals.

For more information, go to www.bpirx.com or call 1-800-367-3395.

What are the ingredients in oxcarbazepine tablets?
Active ingredient: oxcarbazepine
Inactive ingredients:

Allergen Statement: This product contains soy.

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

Distributed by:
American Health Packaging
Columbus, OH 43217

8284501/0119


3
Contains FD&C Yellow No. 6 as a color additive.
4
This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Revised: 3/2019
American Health Packaging