SPL MEDGUIDE SECTION

See FDA-approved Patient Labeling (Medication Guide).

Counsel patients on the benefits and risks of receiving levetiracetam. Provide the Medication Guide to patients and/or caregivers, and instruct them to read the Medication Guide prior to taking levetiracetam. Instruct patients to take levetiracetam only as prescribed.

Suicidal Behavior and Ideation

Counsel patients, their caregivers, and/or families that antiepileptic drugs (AEDs), including levetiracetam, may increase the risk of suicidal thoughts and behavior and advise patients to be alert for the emergence or worsening of symptoms of depression; unusual changes in mood or behavior; or suicidal thoughts, behavior, or thoughts about self-harm. Advise patients, their caregivers, and/or families to immediately report behaviors of concern to a healthcare provider.

Psychiatric Reactions and Changes in Behavior

Advise patients that levetiracetam may cause changes in behavior (e.g. aggression, agitation, anger, anxiety, apathy, depression, hostility, and irritability) and in rare cases, psychotic symptoms have occurred.

Effects on Driving or Operating Machinery

Inform patients that levetiracetam may cause dizziness and somnolence. Inform patients not to drive or operate machinery until they have gained sufficient experience on levetiracetam to gauge whether it adversely affects their ability to drive or operate machinery.

Dermatological Adverse Reactions

Advise patients that serious dermatological adverse reactions have occurred in patients treated with levetiracetam and instruct them to call their physician immediately if a rash develops.

Pregnancy

Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during levetiracetam therapy. Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States.

MADE IN INDIA.

November 2013                                                         ID# 233259

MEDICATION GUIDE

LEVETIRACETAM TABLETS USP

250 mg, 500 mg, 750 mg and 1000 mg

Rx only

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 are levetiracetam tablets?

Levetiracetam tablets are 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 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:

•   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 tablets 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 these registries is to collect information about the safety of levetiracetam 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 tablets 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 tablets are usually taken twice a day. Take levetiracetam tablets 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 you miss a dose of levetiracetam tablets, 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 tablets affect you. Levetiracetam tablets may make you dizzy or sleepy.

What are the possible side effects of levetiracetam tablets?

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

Levetiracetam tablets 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)
•   a skin rash. Serious skin rashes can happen after you start taking levetiracetam tablets. There is no way to tell if a mild rash will become a serious reaction.

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

•   sleepiness
•   weakness
•   infection
•   dizziness

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

•   tiredness
•   acting aggressive
•   nasal congestion
•   decreased appetite
•   irritability

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. 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) 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?

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 #2 aluminum lake

500 mg tablets: Yellow Iron Oxide

750 mg tablets: FD&C Blue #2 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide red

For 1000 mg strength:

Inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

Levetiracetam tablets do not contain lactose or gluten.

Information on the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.'s levetiracetam tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

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

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States.

MADE IN INDIA.

November 2013                                                         ID#: 233261

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Levetiracetam Tablets USP

Rx Only

250 mg

NDC 68180-112-02

500's Bottle Pack