OXCARBAZEPINE- oxcarbazepine tablet, film coated
TYA Pharmaceuticals
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MEDICATION GUIDE Oxcarbazepine Tablets
Oxcarbazepine Tablets 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:
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.
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.
Call a doctor 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 taking oxcarbazepine tablets without first talking to a healthcare provider.
Stopping oxcarbazepine tablets 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?
Oxcarbazepine tablets are a prescription medicine used:
Who should not take oxcarbazepine tablets?
What should I tell my healthcare provider before taking oxcarbazepine tablets?
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 non-prescription 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?
The most common side effects of oxcarbazepine tablets include:
These are not all the possible side effects of oxcarbazepine tablets. 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 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.
This Medication Guide summarizes the most important information about oxcarbazepine tablets. 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 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?
oxcarbazepine Active ingredient:
microcrystalline cellulose, crospovidone, hypromellose, colloidal silicon dioxide, magnesium stearate, talc. Coating: polyvinyl alcohol, talc, titanium dioxide, polyethylene glycol, FD&C Yellow No. 6 aluminum lake, lecithin, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 5 aluminum lake. Inactive ingredients:34
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Distributed by: Boca Raton, FL 33487
BRECKENRIDGE PHARMACEUTICAL, INC.
Manufactured by: Irvine, CA 92614
NEXGEN PHARMA, INC.
05/13