OXCARBAZEPINE- oxcarbazepine suspension 
Precision Dose, Inc.

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MEDICATION GUIDE
Oxcarbazepine (ox-kar-BAY-zeh-peen) Oral Suspension, USP

Read this Medication Guide before you start taking oxcarbazepine oral suspension 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 oral suspension?

Do not stop taking oxcarbazepine oral suspension without first talking to your healthcare provider.

Stopping oxcarbazepine oral suspension suddenly can cause serious problems.

Oxcarbazepine oral suspension can cause serious side effects, including:

1.
Oxcarbazepine oral suspension 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 oral suspension. 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 oral suspension 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. Tell your healthcare provider if you are allergic to carbamazepine.
3.
Like other antiepileptic drugs, oxcarbazepine oral suspension 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 oral suspension without first talking to a healthcare provider.
Stopping oxcarbazepine oral suspension 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 is oxcarbazepine oral suspension?

Oxcarbazepine oral suspension is a prescription medicine used:

Who should not take oxcarbazepine oral suspension?

What should I tell my healthcare provider before taking oxcarbazepine oral suspension?

Before taking oxcarbazepine oral suspension, 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 nonprescription medicines, vitamins and herbal supplements.

Taking oxcarbazepine oral suspension 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 oral suspension?

What should I avoid while taking oxcarbazepine oral suspension?

What are the possible side effects of oxcarbazepine oral suspension?

See "What is the most important information I should know about oxcarbazepine oral suspension?"

 
Oxcarbazepine oral suspension may cause other serious side effects including:
  • your seizures can happen more often or become worse
  • trouble concentrating
  • problems with your speech and language
  • feeling confused
  • feeling sleepy and tired
  • trouble walking and with coordination
 
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 oral suspension?"
The most common side effects of oxcarbazepine oral suspension include:
  • dizziness
  • sleepiness
  • double vision
  • tiredness
  • nausea
  • vomiting
  • problems with vision
  • stomach pain
  • trembling
  • upset stomach
  • problems with walking and coordination (unsteadiness)
  • rash
  • infections (especially in children)

These are not all the possible side effects of oxcarbazepine oral suspension. For more information, ask your healthcare provider or pharmacist. 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 oral suspension?

Keep oxcarbazepine oral suspension and all medicines out of the reach of children.

General Information about the safe and effective use of oxcarbazepine oral suspension

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use oxcarbazepine oral suspension for a condition for which it was not prescribed. Do not give oxcarbazepine oral suspension 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 oxcarbazepine oral suspension. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for the full prescribing information about oxcarbazepine oral suspension that is written for health professionals.

For more information, go to www.amneal.com or call 1-877-835-5472.

What are the ingredients in oxcarbazepine oral suspension, USP?

Active ingredient: oxcarbazepine, USP

Inactive ingredients:

Oral suspension: colloidal silicon dioxide, malic acid, methylparaben, polyethylene glycol, pregelatinized starch (maize), propyl paraben, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol, xanthan gum and yellow plum lemon flavor. Hydrochloric acid solution or sodium hydroxide solution may be added for adjustment of pH.

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

Manufactured by:
Amneal Pharmaceuticals
Branchburg, NJ 08876

Distributed by:
Amneal Pharmaceuticals
Glasgow, KY 42141

Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080

LI940 Rev. 07/15

Revised: 9/2017
Precision Dose, Inc.