LEVETIRACETAM - levetiracetam tablet, film coated, extended release
Physicians Total Care, Inc.
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 them.
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 are levetiracetam extended-release tablets?
Levetiracetam extended-release tablets are 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, oval-shaped, film-coated extended-release tablets imprinted with “TV/7795” with black ink on one side and plain on the other.
750 mg levetiracetam extended-release tablets are white, oval-shaped, film-coated extended-release tablets imprinted with “TV/7796” with black ink on one side and plain on the other.
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 FDA at 1-800-FDA-1088.
How should I store levetiracetam extended-release tablets?
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 they were not prescribed. Do not give levetiracetam extended-release tablets to other people, even if they have the same symptoms that you have. They 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. You can also get information about levetiracetam extended-release tablets by calling 1-888-838-2872, MEDICAL AFFAIRS.
What are the ingredients of levetiracetam extended-release tablets?
Levetiracetam extended-release tablet active ingredient: levetiracetam
Inactive ingredients: dibutyl sebacate, ethylcellulose, hydrogenated castor oil powder, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, and titanium dioxide. The imprinting ink contains iron oxide black and shellac glaze.
Levetiracetam extended-release tablets do not contain lactose or gluten.
This Medication Guide has been approved by the US Food and Drug Administration.
Manufactured In Israel By:
TEVA PHARMACEUTICAL IND. LTD.
Jerusalem, 91010, Israel
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. A 1/2011