LEVETIRACETAM- levetiracetam tablet, film coated 
Amneal Pharmaceuticals of New York, LLC

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MEDICATION GUIDE

Levetiracetam Tablets, USP

Read this Medication Guide before you start taking levetiracetam 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?


Like other antiepileptic drugs, levetiracetam 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 without first talking to a healthcare provider.

How can I watch for early symptoms of suicidal thoughts and actions?

What is levetiracetam?

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

It is not known if levetiracetam is safe or effective in children under 1 month 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 provided below. Tell your pharmacist immediately if you think you have been given the wrong medicine.

Levetiracetam tablets, 250 mg, are blue, oblong-shaped, scored, film-coated tablets debossed with “OL” and “250” on one side.

Levetiracetam tablets, 500 mg, are yellow, oblong-shaped, scored, film-coated tablets debossed with “OL” and “500”on one side.

Levetiracetam tablets, 750 mg, are dark pink, oblong-shaped, scored, film-coated tablets debossed with “OL” and “750” on one side.

Levetiracetam tablets, 1000 mg, are white, oblong-shaped, scored, film-coated tablets debossed with “OL” and “1000” on one side.

What should I tell my healthcare provider before starting levetiracetam?

Before taking levetiracetam, 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 nonprescription 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?

Take levetiracetam tablets exactly as prescribed.


What should I avoid while taking levetiracetam?

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


What are the possible side effects of levetiracetam?

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

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

These side effects can happen at any time but happen more often within the first 4 weeks of treatment except for infection.

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. 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 levetiracetam.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use levetiracetam for a condition for which it was not prescribed. Do not give levetiracetam 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 levetiracetam. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about levetiracetam that is written for health professionals. You can also get information about levetiracetam at www.amneal.com or call 1-877-835-5472.


What are the ingredients of levetiracetam tablets?


Levetiracetam tablet active ingredient: levetiracetam, USP

Inactive ingredients: copovidone, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, polysorbate 80, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide, 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 Red #40/Allura Red A C Aluminum Lake

Levetiracetam tablets do not contain lactose or gluten.

Information on the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets. However, due to UCB Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

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

Revised: 03/2014
 
Amneal Pharmaceuticals of New York, LLC