LEVETIRACETAM EXTENDED-RELEASE- levetiracetam tablet, film coated, extended release 
Trupharma, LLC


Levetiracetam Extended-Release Tablets

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?

What islevetiracetam extended-release tablets?

Levetiracetam extended-release tablet is a prescription medicine taken by mouth that is used with other medicines to treat partial onset seizures in people 16 years of age and older with epilepsy.

It is not known if levetiracetam extended-release tablets are safe or effective in people under 16 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.

500 mg levetiracetam extended-release tablets are white, oblong-shaped, film coated tablets marked with "P46" in green on one side.

750 mg levetiracetam extended-release tablets are white, oblong-shaped, film-coated tablets marked with "P47" in green on one side.

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 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 extended-release tablets?

Take levetiracetam extended-release tablets exactly as prescribed.

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?

Levetiracetam extended-release tablets can cause serious side effects.

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

Common side effects seen in people who take levetiracetam extended-release tablets and other formulations of levetiracetam include:

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

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 Anchen Pharmaceuticals at 1-888-493-0857 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

How should I store levetiracetam extended-release tablets?

Store levetiracetam extended-release tablets at room temperature, 20 to 25ºC (68 to 77ºF) [see USP Controlled Room Temperature] away from heat and light.
Keep levetiracetam extended-release tablets and all medicines out of the reach of children.

General information about 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.

This Medication Guide summarizes the most important information about levetiracetam extended-release tablets. If you would like more information, talk with your healthcare provider. 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 of levetiracetam extended-release tablets?

Levetiracetam extended-release tablet active ingredient: levetiracetam

Inactive ingredients: alcohol (anhydrous), colloidal silicon dioxide, ethylcellulose, magnesium stearate, microcrystalline cellulose and talc. The imprinting ink contains ammonium hydroxide, D&C yellow #10, FD&C blue #1, isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac and titanium dioxide. Levetiracetam extended-release does not contain lactose or gluten.

Rx only

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

Manufactured for:

TruPharma, LLCC
Tampa, Florida 33609www.trupharma.com

Rev. 01/2016

Revised: 9/2019
Trupharma, LLC