MEDICATION GUIDE

Levetiracetam Tablets

250 mg, 500 mg and 750 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:

• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood

Do not stop levetiracetam tablets without first talking to a healthcare provider.

• Stopping levetiracetam tablets suddenly can cause serious problems. Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus).
• Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

How can I watch for early symptoms of suicidal thoughts and actions?

• Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.
• Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

What is levetiracetam tablet?

Levetiracetam tablet is a prescription medicine taken by mouth that is used with other medicines to treat:

• partial onset seizures in people 4 years of age and older with epilepsy
• 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 tablet 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 levetiracetam tablets provided below. Contact your pharmacist immediately if you believe a dispensing error may have occurred.

Levetiracetam tablets, 250 mg are yellow colored, film coated, oblong, biconvex, debossed with "L" breakline and "250" on one side and plain on the other side.

Levetiracetam tablets, 500 mg are orange colored, film coated, oblong, biconvex, debossed with "L" breakline and "500" on one side and plain on the other side.

Levetiracetam tablets, 750 mg are blue colored, film coated, oblong, biconvex, debossed with "L" breakline and "750" on one side and plain 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:

• have or have had depression, mood problems or suicidal thoughts or behavior
• have kidney problems
• are pregnant or planning to become pregnant. It is not known if levetiracetam will harm your unborn baby. You and your healthcare provider will have to decide if you should take levetiracetam tablets while you are pregnant. If you become pregnant while taking levetiracetam tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about safety of levetiracetam tablets and other antiepileptic medicine during pregnancy.
• are breast feeding. Levetiracetam can pass into your milk and may harm your baby. You and your healthcare provider should discuss whether you should take levetiracetam or breast feed; you should not do both.

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.

• Your healthcare provider will tell you how much levetiracetam tablets to take and when to take it. Levetiracetam tablet is usually taken twice a day. Take levetiracetam tablet at the same times each day.
• Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
• Take levetiracetam tablets with or without food.
• Swallow the tablets whole. Do not chew or crush tablets. Ask your healthcare provider for levetiracetam oral solution if you cannot swallow tablets.
• If your healthcare provider has prescribed levetiracetam oral solution, be sure to ask your pharmacist for a medicine dropper or medicine cup to help you measure the correct amount of levetiracetam oral solution. Do not use a household teaspoon. Ask your pharmacist for instructions on how to use the measuring device the right way.
• If you miss a dose of levetiracetam tablet, take it as soon as you remember. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. Do not take two doses at the same time.
• If you take too much levetiracetam tablets, call your local Poison Control Center or go to the nearest emergency room right away.

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 tablet?

See "What is the most important information I should know about levetiracetam tablet?"

Levetiracetam tablet can cause serious side effects.

Call your healthcare provider right away if you have any of these symptoms:

• mood and behavior changes such as aggression, agitation, anger, anxiety, apathy, mood swings, depression, hostility, and irritability. A few people may get psychotic symptoms such as hallucinations (seeing or hearing things that are really not there), delusions (false or strange thoughts or beliefs) and unusual behavior.
• extreme sleepiness, tiredness, and weakness
• problems with muscle coordination (problems walking and moving)

The most common side effects seen in people who take levetiracetam tablets include:

• sleepiness
• weakness
• dizziness
• infection

The most common side effects seen in children who take levetiracetam tablets include, in addition to those listed above:

• accidental injury
• irritability
• hostility

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 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.

How should I store levetiracetam tablets?

• Store levetiracetam tablets at room temperature 59° F to 86° F (15°C to 30°C) 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 healthcare professionals. 

What are the ingredients of levetiracetam tablets?

Levetiracetam tablet active ingredient: levetiracetam USP.

Inactive ingredients: colloidal silicon dioxide, corn starch,croscarmellose sodium, magnesium stearate, povidone and additional agents listed below:

250 mg tablets: Opadry Yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, polyethylene glycol 4000, iron oxide yellow and FD&C Blue #2/indigo carmine aluminum lake).

500 mg tablets: Opadry Orange (hypromellose 3cP, hypromellose 6cP, titanium dioxide, polyethylene glycol 4000, iron oxide red, FD&C Yellow #6/sunset yellow FCF aluminum lake and FD&C Blue #2/indigo carmine aluminum lake).

750 mg tablets: Opadry Blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, polyethylene glycol 4000 and FD&C Blue #2/indigo carmine aluminum lake).

Levetiracetam tablet does not contain lactose or gluten.

Rx Only

This Medication Guide has been approved by the US Food and Drug Administration.

Manufactured by

Orchid Healthcare

(A Division of Orchid Chemicals & Pharmaceuticals Ltd.)

Irungattukottai-602 105, India

Manufactured for

Karalex Pharma, LLC

700 Alexander Park, Suite 104

Princeton NJ 08540

Issued: December, 2010

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320