LEVETIRACETAM - levetiracetam tablet, film coated 
Aurobindo Pharma Limited

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MEDICATION GUIDE

Levetiracetam Tablets USP, for oral use

(lee'' ve tye ra' se tam)


Read this Medication Guide before you start taking levetiracetam 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 levetiracetam tablets?


Like other antiepileptic drugs, levetiracetam tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:


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


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

What are levetiracetam tablets?


Levetiracetam tablets are a prescription medicine taken by mouth that is used to treat partial-onset seizures in people 1 month of age and older.


Levetiracetam tablets are a prescription medicine taken by mouth that is used with other medicines to treat:

It is not known if levetiracetam tablets are safe or effective in children under:

Before taking your medicine, make sure you have received the correct medicine. Compare the name above with the name on your bottle and the appearance of your medicine with the description of levetiracetam tablets provided below. Tell your pharmacist immediately if you think you have been given the wrong medicine.


Who should not take levetiracetam tablets?

Do not take levetiracetam tablets if you are allergic to levetiracetam.


What should I tell my healthcare provider before starting levetiracetam tablets?


Before taking levetiracetam tablets, tell your healthcare provider about all of 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. Do not start a new medicine without first talking with your healthcare provider.


Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.


How should I take levetiracetam tablets?


What should I avoid while taking levetiracetam tablets?


Do not drive, operate machinery or do other dangerous activities until you know how levetiracetam tablets affect you. Levetiracetam tablets may make you dizzy or sleepy.


What are the possible side effects of levetiracetam tablets?

Levetiracetam tablets can cause serious side effects including:

•    See “What is the most important information I should know about levetiracetam tablets?”

Call your healthcare provider right away if you have any of these symptoms:

The most common side effects seen in people who take levetiracetam tablets include:


The most common side effects seen in children who take levetiracetam tablets include, in addition to those listed above include:


Tell your healthcare provider if you have any side effect that bothers you or that does not go away.


These are not all the possible side effects of levetiracetam tablets. For more information, ask your healthcare provider or pharmacist.


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 levetiracetam tablets?


General information about the safe and effective use of levetiracetam tablets.


Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use levetiracetam tablets for a condition for which it was not prescribed. Do not give levetiracetam tablets to other people, even if they have the same symptoms that you have. They may harm them. You can ask your pharmacist or healthcare provider information about levetiracetam tablets that is written for health professionals.


What are the ingredients in levetiracetam tablets?


Active ingredient: levetiracetam


Inactive ingredients: corn starch, colloidal silicon dioxide, povidone, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, purified water and additional agents listed below:  


250 mg tablets: FD&C Blue #2/indigo carmine aluminum lake


500 mg tablets: iron oxide yellow      


750 mg tablets: FD&C Yellow #6/sunset yellow FCF aluminum lake, FD&C Blue #2/indigo carmine aluminum lake and iron oxide red.


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


Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides


Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 032, India

Revised: 04/2022

Revised: 4/2022
Aurobindo Pharma Limited