TRILEPTAL- oxcarbazepine tablet, film coated
TRILEPTAL- oxcarbazepine suspension
Novartis Pharmaceuticals Corporation
|This Medication Guide has been approved by the U.S. Food and Drug Administration||Revised: May 2020|
film-coated tablets, for oral use
|What is the most important information I should know about TRILEPTAL?
Do not stop taking TRILEPTAL without first talking to your healthcare provider. Stopping TRILEPTAL suddenly can cause serious problems.
TRILEPTAL can cause serious side effects, including:
1. TRILEPTAL may cause the level of sodium in your blood to be low. Symptoms of low blood sodium include:
|• nausea||• confusion|
|• tiredness (lack of energy)||• more frequent or more severe seizures|
|Similar symptoms that are not related to low sodium may occur from taking TRILEPTAL. 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 TRILEPTAL.
2. TRILEPTAL 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||• painful sores in the mouth or around your eyes|
|• trouble swallowing or breathing||• yellowing of your skin or eyes|
|• a skin rash||• unusual brusing or bleeding|
|• hives||• severe fatigue or weakness|
|• fever, swollen glands, or sore throat that do not go away or come and go||• severe muscle pain|
|• frequent infections or infections that do not go away|
|Many people who are allergic to carbamazepine are also allergic to TRILEPTAL. Tell your healthcare provider if you are allergic to carbamazepine.
3. Like other antiepileptic drugs (AEDs), TRILEPTAL 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:
|• thoughts about suicide or dying||• trouble sleeping (insomnia)|
|• attempts to commit suicide||• new or worse irritability|
|• new or worse depression||• acting aggressive, being angry, or violent|
|• new or worse anxiety||• acting on dangerous impulses|
|• feeling agitated or restless||• an extreme increase in activity and talking (mania)|
|• panic attacks||• other unusual changes in behavior or mood|
How can I watch for early symptoms of suicidal thoughts and actions?
Do not stop taking TRILEPTAL without first talking to a healthcare provider.
|What is TRILEPTAL?
TRILEPTAL is a prescription medicine used:
|Do not take TRILEPTAL if you are allergic to TRILEPTAL or any of the other ingredients in TRILEPTAL, or to eslicarbazepine acetate. See the end of this Medication Guide for a complete list of ingredients in TRILEPTAL.
Many people who are allergic to carbamazepine are also allergic to TRILEPTAL. Tell your healthcare provider if you are allergic to carbamazepine.
|Before taking TRILEPTAL, tell your healthcare provider about all your medical conditions, including if you:
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
|How should I take TRILEPTAL?
|What should I avoid while taking TRILEPTAL?
|What are the possible side effects of TRILEPTAL?
See “What is the most important information I should know about TRILEPTAL?”
TRILEPTAL may cause other serious side effects, including:
The most common side effects of TRILEPTAL include:
|• dizziness||• problems with vision|
|• sleepiness||• trembling|
|• double vision||• problems with walking and coordination (unsteadiness)|
|• tiredness||• rash|
|These are not all the possible side effects of TRILEPTAL. 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 TRILEPTAL?
|General Information about the safe and effective use of TRILEPTAL.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TRILEPTAL for a condition for which it was not prescribed. Do not give TRILEPTAL 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 TRILEPTAL that is written for health professionals.
|What are the ingredients in TRILEPTAL?
Active ingredient: oxcarbazepine
For more information, go to www.novartis.us or call 1-888-669-6682.