MEDICATION GUIDELEVETIRACETAM TABLETS

1000 mg

Read this Medication Guide before you start takingLEVETIRACETAM TABLETS and each time you get a refill.There may be new information. This information does nottake the place of talking to your healthcare provider aboutyour medical condition or treatment.What is the most important information I should know aboutLEVETIRACETAM TABLETS?Like other antiepileptic drugs, LEVETIRACETAM TABLETSmay cause suicidal thoughts or actions in a very smallnumber of people, about 1 in 500 people taking it.Call a healthcare provider right away if you have any ofthese symptoms, especially if they are new, worse, or worryyou:• 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 moodDo not stop LEVETIRACETAM TABLETS without first talkingto a healthcare provider.• Stopping LEVETIRACETAM TABLETS suddenly can cause

serious problems. Stopping a seizure medicine suddenlycan cause seizures that will not stop (status epilepticus).

• Suicidal thoughts or actions can be caused by things otherthan 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 thoughtsand 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 takenby mouth that is used with other medicines to treat:• partial onset seizures in people 4 years of age and older

with epilepsyIt is not known if LEVETIRACETAM TABLET is safe or effectivein children under 4 years of age.Before taking your medicine, make sure you have receivedthe correct medicine. Compare the name above with the nameon your bottle and the appearance of your medicine with the

description of LEVETIRACETAM TABLETS provided below.Contact your pharmacist immediately if you believe adispensing error may have occurred.LEVETIRACETAM TABLETS, 1000 mg are white to off-white,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 startingLEVETIRACETAM TABLETS?Before taking LEVETIRACETAM TABLETS, tell your healthcareprovider about all of your medical conditions, including ifyou:• 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 unbornbaby. You and your healthcare provider will have to decideif you should take LEVETIRACETAM TABLETS while youare pregnant. If you become pregnant while takingLEVETIRACETAM TABLETS, talk to your healthcareprovider about registering with the North AmericanAntiepileptic Drug Pregnancy Registry. You can enroll inthis registry by calling 1-888-233-2334.

• are breast feeding. LEVETIRACETAM TABLETS can passinto your milk and may harm your baby. You and yourhealthcare provider should discuss whether you shouldtake LEVETIRACETAM TABLETS or breast-feed; you shouldnot 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 newmedicine without first talking with your healthcare provider.Know the medicines you take. Keep a list of them to showyour healthcare provider and pharmacist each time you get anew 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 is usually taken twice a day.Take LEVETIRACETAM TABLETS at the same times eachday.

• Your healthcare provider may change your dose. Do notchange your dose without talking to your healthcareprovider.

• Take LEVETIRACETAM TABLETS with or without food.• Swallow the tablets whole. Do not chew or crush tablets.• If you miss a dose of LEVETIRACETAM TABLETS, take it

as soon as you remember. If it is almost time for your nextdose, just skip the missed dose. Take the next dose atyour regular time. Do not take two doses at the sametime.

• If you take too much LEVETIRACETAM TABLETS, call yourlocal Poison Control Center or go to the nearest emergencyroom right away.

TEMPLE Packaging Pvt. Ltd. 28476001 Email:-temple@bom4.vsnl.net.in

Customer: Lupin Pharma Location: Goa

Product Code & Name: 218953 Levetiracetam Tab 1000 mg Med Guide (Booklet-Front)

SAP Code: 60100000165 File No: 9864

Version No.: 11 Date: 15.10.2009

Open Size: 250 x 180 mm

Folding Size: Flat Pharma code: xxx

Colours: 1 Perforation: Yes(printed line)

Substrate: 60 maplitho paper Gluing: No

Artwork Sr. No.: 61/08/09

Artwork Status: in process

Note - This approval will be considered for final printing.Please recheck for corrections indicated earlier, in this proof also.

Prepared by : Checked by: Profile Checked: Approved by:

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What should I avoid while taking LEVETIRACETAMTABLETS?Do not drive, operate machinery or do other dangerousactivities until you know how LEVETIRACETAM TABLETSaffects you. LEVETIRACETAM TABLETS may make you dizzyor sleepy.What are the possible side effects of LEVETIRACETAMTABLETS?• See “What is the most important information I should know

LEVETIRACETAM TABLETS?”LEVETIRACETAM TABLETS can cause serious side effects.Call your healthcare provider right away if you have any ofthese symptoms:• mood and behavior changes such as aggression, agitation,

anger, anxiety, apathy, mood swings, depression, hostility,and irritability. A few people may get psychotic symptomssuch as hallucinations (seeing or hearing things that arereally not there), delusions (false or strange thoughts orbeliefs) 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 takeLEVETIRACETAM TABLETS include:• sleepiness• weakness• dizziness• infectionThe most common side effects seen in children who takeLEVETIRACETAM TABLETS include, in addition to those listedabove:• accidental injury• irritability• hostilityThese side effects can happen at any time but happen moreoften within the first 4 weeks of treatment except for infection.Tell your healthcare provider if you have any side effect thatbothers you or that does not go away.These are not all the possible side effects of LEVETIRACETAMTABLETS. For more information, ask your healthcare provideror pharmacist.Call your doctor for medical advice about side effects. Youmay 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 LEVETIRACETAM TABLETS at 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 thanthose listed in a Medication Guide. Do not use

LEVETIRACETAM TABLETS for a condition for which it wasnot prescribed. Do not give LEVETIRACETAM TABLETS toother people, even if they have the same symptoms that youhave. It may harm them.This Medication Guide summarizes the most importantinformation about LEVETIRACETAM TABLETS. If you wouldlike more information, talk with your healthcare provider. Youcan ask your pharmacist or healthcare provider forinformation about LEVETIRACETAM TABLETS that is writtenfor health professionals.What are the ingredients of LEVETIRACETAM TABLETS?LEVETIRACETAM TABLETS contain the labeled amount oflevetiracetam. Inactive ingredients: colloidal silicon dioxide,corn starch, croscarmellose sodium, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone,polyvinyl alcohol, talc and titanium dioxide.LEVETIRACETAM TABLETS does not contain lactose orgluten. It does contain carbohydrates.

Rx Only

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

Manufactured forLupin Pharmaceuticals, Inc.Baltimore, Maryland 21202United States

Manufactured byLupin LimitedGoa 403 722INDIA

Revised: November 2009 ID#: 218953

TEMPLE Packaging Pvt. Ltd. 28476001 Email:-temple@bom4.vsnl.net.in

Customer: Lupin Pharma Location: Goa

Product Code & Name: 218953 Levetiracetam Tab 1000 mg Med Guide (Booklet-Back)

SAP Code: 60100000165 File No: 9864

Version No.: 11 Date: 15.10.2009

Open Size: 250 x 180 mm

Folding Size: Flat Pharma code: xxx

Colours: 1 Perforation: Yes(printed line)

Substrate: 60 maplitho paper Gluing: No

Artwork Sr. No.: 61/08/09

Artwork Status: in process

Note - This approval will be considered for final printing.Please recheck for corrections indicated earlier, in this proof also.

Prepared by : Checked by: Profile Checked: Approved by:

shaji