LEVETIRACETAM- levetiracetam tablet, film coated 
Qualitest Pharmaceuticals

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MEDICATION GUIDE

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?

What are levetiracetam tablets?

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

Levetiracetam 250 mg tablets are blue, modified oval-shaped, convex, scored, film-coated tablets debossed “3842” on one side and debossed “V” on the reverse side.

Levetiracetam 500 mg tablets are yellow, modified oval-shaped, convex, scored, film-coated tablets debossed “3843” on one side and debossed “V” on the reverse side.

Levetiracetam 750 mg tablets are pink, modified oval-shaped, convex, scored, film-coated tablets debossed “3844” on one side and debossed “V” on the reverse side.

Levetiracetam 1000 mg tablets are white, modified oval-shaped, convex, scored, film-coated tablets debossed “3845” on one side and debossed “V” on the reverse side.

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 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 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.

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:

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 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 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 they were not prescribed. Do not give levetiracetam 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 levetiracetam tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about levetiracetam tablets that is written for health professionals

What are the ingredients of levetiracetam tablets?

Levetiracetam tablet active ingredient: levetiracetam

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and additional agents listed below:

250 mg tablets: D&C Red #27/phloxine aluminum lake, FD&C Blue #2/indigo carmine aluminum lake, polyvinyl alcohol, talc

500 mg tablets: D&C Yellow #10 aluminum lake, FD&C Blue #2/indigo carmine aluminum lake, hypromellose, polysorbate 80

750 mg tablets: FD&C Blue #2/indigo carmine aluminum lake, FD&C Red #40/allura red AC aluminum lake, polyvinyl alcohol, talc

1000 mg tablets: hypromellose, lactose monohydrate, stearic acid, triacetin

Levetiracetam tablets do not contain gluten. Levetiracetam 250 mg, 500 mg and 750 mg tablets do not contain lactose. Levetiracetam 1000 mg tablets contain lactose.

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 and oral solution. 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 U.S. Food and Drug Administration.

Revised: 01/2013
 
Qualitest Pharmaceuticals