LEVETIRACETAM- levetiracetam tablet, film coated
NCS HealthCare of KY, LLC dba Vangard Labs
TABLETS USP 250 mg, 500 mg, 750 mg and 1000 mg
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 tablets USP, 250 mg are blue coloured, oblong-shaped, biconvex, film-coated tablets debossed with "L" and "U" on either side of the breakline on one side and "X01" on the other side.
Levetiracetam tablets USP, 500 mg are yellow coloured, oblong-shaped, biconvex, film-coated tablets debossed with "L" and "U" on either side of the breakline on one side and "X02" on the other side.
Levetiracetam tablets USP, 750 mg are orange coloured, oblong-shaped, biconvex, film-coated tablets debossed with "L" and "U" on either side of the breakline on one side and "X03" on the other side.
Levetiracetam tablets USP, 1000 mg are white to off-white coloured, oblong-shaped, biconvex, film-coated tablets debossed with "L" and "U" on either side of the breakline on one side and "X04" on the other 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 tablet affects 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
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. You may also report side effects to Lupin Pharmaceuticals, Inc. at 1-800-399-2561.
How should I store levetiracetam tablets?
Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].away from heat and light.
Keep levetiracetam tablets and all medicines out of the reach of children.
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 it was 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. You can also get information about levetiracetam tablets at www.lupinpharmaceuticals.com or call 1-800-399-2561.
What are the ingredients of levetiracetam tablets?
active ingredient: levetiracetam
For 250 mg, 500 mg and 750 mg strengths:
Inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below:
250 mg tablets: FD & C Blue No. 2/indigo carmine Aluminum Lake
500 mg tablets: Yellow Iron Oxide
750 mg tablets: FD & C Blue No. 2/indigo carmine Aluminum Lake, FD & C Yellow No. 6/sunset yellow FCF Aluminum Lake, iron oxide red
For 1000 mg strength:
Inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
Levetiracetam tablets do not contain lactose or gluten.
This Medication Guide has been approved by the US Food and Drug Administration.
Lupin Pharmaceuticals, Inc.
Baltimore, Maryland 21202
MADE IN INDIA.
Revised: August 2015 ID#: 241684