LEVETIRACETAM - levetiracetam tablet, film coated
Lupin Pharmaceuticals, Inc.
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:
Levetiracetam tablets are a prescription medicine taken by mouth that is used to treat partial-onset seizures in people 1 month of age and older.
Levetiracetam tablets are a prescription medicine taken by mouth that is used with other medicines to treat:
myoclonic seizures in people 12 years of age and older with juvenile myoclonic epilepsy
primary generalized tonic-clonic seizures in people 6 years of age and older with certain types of generalized epilepsy.
It is not known if levetiracetam tablets are safe or effective in children under
1 month of age to treat partial-onset seizures
12 years of age to treat myoclonic seizures
6 years of age to treat primary generalized tonic-clonic seizures
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.
Who should not take levetiracetam tablets?
Do not take levetiracetam tablets if you are allergic to levetiracetam.
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 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 levetiracetam tablets?
Take levetiracetam tablets exactly as prescribed.
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?
can cause serious side effects including:
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 safe and effective use of 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. You can ask your pharmacist or healthcare provider information about over-the counter that is written for health professionals
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, polyethylene glycol, polyvinyl alcohol, povidone, 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, polyethylene glycol, polyvinyl alcohol, povidone, 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: February 2021 ID#: 266798