OXCARBAZEPINE- oxcarbazepine tablet, film coated 
Bryant Ranch Prepack

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MEDICATION GUIDE

(ox kar baz' e peen)
Oxcarbazepine Tablets, USP

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, USP 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, USP?

 
Do not stop taking oxcarbazepine tablets, USP without first talking to your healthcare provider.
 
Stopping oxcarbazepine tablets, USP suddenly can cause serious problems.
 
Oxcarbazepine tablets, USP can cause serious side effects, including:
  1. Oxcarbazepine tablets, USP may cause the level of sodium in your blood to be low. Symptoms of low blood sodium include:
    • nausea
    • tiredness, lack of energy
    • headache
    • confusion
    • more frequent or more severe seizures.

    Similar symptoms that are not related to low sodium may occur from taking oxcarbazepine tablets, USP. 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.
  2. Oxcarbazepine tablets, USP 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:
    • swelling of your face, eyes, lips, or tongue
    • trouble swallowing or breathing
    • a skin rash
    • hives
    • fever, swollen glands, or sore throat that do not go away or come and go
    • painful sores in the mouth or around your eyes
    • yellowing of your skin or eyes
    • unusual bruising or bleeding
    • severe fatigue or weakness
    • severe muscle pain
    • frequent infections or infections that do not go away

    Many people who are allergic to carbamazepine are also allergic to oxcarbazepine tablets, USP. Tell your healthcare provider if you are allergic to carbamazepine.
  3. Like other antiepileptic drugs, oxcarbazepine tablets, USP may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
    Call a doctor right away if you have any of these symptoms, especially if they are new, worse, or worry you:
    • thoughts about suicide or dying
    • attempts to commit suicide
    • new or worse depression
    • new or worse anxiety
    • feeling agitated or restless
    • panic attacks
    • trouble sleeping (insomnia)
    • new or worse irritability
    • acting aggressive, being angry, or violent
    • acting on dangerous impulses
    • an extreme increase in activity and talking (mania)
    • other unusual changes in behavior or mood
      How can I watch for early symptoms of suicidal thoughts and actions?
    • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
    • Keep all follow-up visits with your healthcare provider as scheduled.
      Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
      Do not stop taking oxcarbazepine tablets, USP without first talking to a healthcare provider.
      Stopping oxcarbazepine tablets, USP suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy may cause seizures that will not stop (status epilepticus).
      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, USP?

Oxcarbazepine tablets, USP are a prescription medicine used:

   Who should not take oxcarbazepine tablets, USP?

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

Distributed by:
BRECKENRIDGE PHARMACEUTICAL, INC.
Boca Raton, FL 33487

Manufactured by:
NEXGEN PHARMA, INC.
Irvine, CA 92614

02/15


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: 5/2018
Bryant Ranch Prepack