LEVETIRACETAM EXTENDED-RELEASE- levetiracetam tablet, film coated, extended release
Par Pharmaceutical, Inc.
Levetiracetam (lee'' ve tye ra' se tam) Extended-Release Tablets
Read this Medication Guide before you start taking extended-release 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 extended-release levetiracetam tablets?
Like other antiepileptic drugs, extended-release 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 extended-release levetiracetam tablets without first talking to a healthcare provider.
How can I watch for early symptoms of suicidal thoughts and actions?
What are extended-release levetiracetam tablets?
Extended-release levetiracetam tablet is a prescription medicine taken by mouth that is used with other medicines to treat partial onset seizures in people 12 years of age and older with epilepsy.
It is not known if extended-release levetiracetam 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 extended-release levetiracetam 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 to off-white, oval shaped, film coated tablets with A195 engraved on one side and plain on the other side.
750 mg levetiracetam extended-release tablets are pale yellow, oval shaped, film coated tablets with A214 engraved on one side and plain on the other side.
Who should not take extended-release levetiracetam tablets?
Do not take extended-release levetiracetam tablets if you are allergic to levetiracetam.
What should I tell my healthcare provider before starting extended-release levetiracetam tablets?
Before taking extended-release 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 extended-release levetiracetam tablets?
Take extended-release levetiracetam tablets exactly as prescribed.
What should I avoid while taking extended-release levetiracetam tablets?
Do not drive, operate machinery or do other dangerous activities until you know how extended-release levetiracetam tablets affect you. Extended-release levetiracetam tablets may make you dizzy or sleepy.
What are the possible side effects of extended-release levetiracetam tablets?
Extended-release levetiracetam 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 extended-release levetiracetam tablets and other formulations of immediate-release levetiracetam tablets include:
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 extended-release levetiracetam 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 Par Pharmaceutical at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
How should I store extended-release levetiracetam tablets?
General information about the safe and effective use of extended-release levetiracetam tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use extended-release levetiracetam tablets for a condition for which it was not prescribed. Do not give extended-release 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 extended-release levetiracetam tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about extended-release levetiracetam tablets that is written for health professionals.
What are the ingredients of extended-release levetiracetam tablets?
Levetiracetam extended-release tablet active ingredient: levetiracetam
Inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc and titanium dioxide.
In addition, the 750 mg strength contains iron oxide yellow and iron oxide red.
Levetiracetam extended-release tablets do not contain lactose or gluten.
This Medication Guide has been approved by the US Food and Drug Administration.
Chestnut Ridge, NY 10977