LEVETIRACETAM EXTENDED-RELEASE- levetiracetam tablet, extended release 
Omnivium Pharmaceuticals LLC



Levetiracetam (lee" ve tye ra' se tam)

Extended-Release Tablets, for oral use

Read this Medication Guide before you start taking levetiracetam extended-release 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 extended-release tablets?

Like other antiepileptic drugs, levetiracetam extended-release 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 extended-release 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 extended-release tablets?

Levetiracetam extended-release tablets are a prescription medicine taken by mouth that is used to treat partial-onset seizures in people 12 years of age and older.

It is not known if levetiracetam extended-release tablets are safe or effective in people under 12 years of age.

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 extended-release tablets provided below. Tell your pharmacist immediately if you think you have been given the wrong medicine.

Who should not take levetiracetam extended-release tablets?

Do not take levetiracetam extended-release tablets if you are allergic to levetiracetam.

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

Before taking levetiracetam extended-release 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 extended-release tablets?

What should I avoid while taking levetiracetam extended-release tablets?

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

What are the possible side effects of levetiracetam extended-release 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 extended-release tablets 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 extended-release tablets. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may also report side effects to FDA at 1-800- FDA-1088.

How should I store levetiracetam extended-release tablets?

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

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use levetiracetam extended-release tablets for a condition for which it was not prescribed. Do not give levetiracetam extended-release tablets 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 levetiracetam extended-release tablets that is written for health professionals.

What are the ingredients in levetiracetam extended-release tablets?

Levetiracetam extended-release tablets active ingredient: levetiracetam

Inactive ingredients: hypromellose,magnesium stearate, colloidal silicon dioxide, titanium dioxide, and triacetin.

Levetiracetam extended-release tablets do not contain lactose.
Levetiracetam extended-release tablets contain no ingredient made from a gluten-containing grain (wheat, barley, or rye).

Manufactured for:
Omnivium Pharmaceuticals LLC.
Rahway, NJ 07065

For more information, call 1-888-807-1048.

This Medication Guide has been approved by the US Food and Drug Administration.                                                                                                                                                                                                                                                                                  Revised: 11/2022

Revised: 10/2023
Omnivium Pharmaceuticals LLC