KEPPRA - levetiracetam tablet, film coated
STAT RX USA LLC
KEPPRA® (KEPP-ruh) (levetiracetam)
tablets and oral solution
Read this Medication Guide before you start taking KEPPRA 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 KEPPRA?
Like other antiepileptic drugs, KEPPRA 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 KEPPRA without first talking to a healthcare provider.
How can I watch for early symptoms of suicidal thoughts and actions?
What is KEPPRA?
KEPPRA is a prescription medicine taken by mouth that is used with other medicines to treat:
It is not known if KEPPRA is safe or effective in children under 4 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 KEPPRA provided below. Tell your pharmacist immediately if you think you have been given the wrong medicine.
250 mg KEPPRA tablets are blue, oblong-shaped, scored, film-coated tablets marked with "ucb 250" on one side.
500 mg KEPPRA tablets are yellow, oblong-shaped, scored, film-coated tablets marked with "ucb 500" on one side.
750 mg KEPPRA tablets are orange, oblong-shaped, scored, film-coated tablets marked with "ucb 750" on one side.
1000 mg KEPPRA tablets are white, oblong-shaped, scored, film-coated tablets marked with "ucb 1000" on one side.
KEPPRA oral solution is a clear, colorless, grape-flavored liquid.
What should I tell my healthcare provider before starting KEPPRA?
Before taking KEPPRA, 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 KEPPRA?
Take KEPPRA exactly as prescribed.
What should I avoid while taking KEPPRA?
Do not drive, operate machinery or do other dangerous activities until you know how KEPPRA affects you. KEPPRA may make you dizzy or sleepy.
What are the possible side effects of KEPPRA?
KEPPRA 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 KEPPRA include:
The most common side effects seen in children who take KEPPRA 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 away.
These are not all the possible side effects of KEPPRA. 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.
How should I store KEPPRA?
General information about KEPPRA.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use KEPPRA for a condition for which it was not prescribed. Do not give KEPPRA 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 KEPPRA. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about KEPPRA that is written for health professionals. You can also get information about KEPPRA at www.keppra.com or call 1-866-822-0068.
What are the ingredients of KEPPRA?
KEPPRA tablet active ingredient: levetiracetam
Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below:
250 mg tablets: FD&C Blue #2/indigo carmine aluminum lake
500 mg tablets: iron oxide yellow
750 mg tablets: FD&C yellow #6/sunset yellow FCF aluminum lake, iron oxide red
KEPPRA oral solution active ingredient: levetiracetam
Inactive ingredients: ammonium glycyrrhizinate, citric acid monohydrate, glycerin, maltitol solution, methylparaben, potassium acesulfame, propylparaben, purified water, sodium citrate dihydrate and natural and artificial flavor.
KEPPRA does not contain lactose or gluten. KEPPRA oral solution does contain carbohydrates. The liquid is dye-free.
This Medication Guide has been approved by the US Food and Drug Administration.
Smyrna, GA 30080
KEPPRA is a registered trademark of the UCB Group of companies
©2009, UCB, Inc., Smyrna, GA 30080
All rights reserved.
Printed in the U.S.A.
Rev. 1E 04/2009