LEVETIRACETAM - levetiracetam tablet, film coated
Hetero Drugs Ltd.,
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MEDICATION GUIDE
Levetiracetam Tablets
Rx Only
Read this Medication Guidebefore you start taking levetiracetam and each time you get a refill. There may be new information. This informationdoes not take the place of talkingto your healthcare provider about your medical condition or treatment
What is the most important information I shouldknow about levetiracetam?
Like other antiepileptic drugs, levetiracetam may cause suicidal thoughts or actions in a very smallnumber of people, about 1 in 500 people taking it.
Call a healthcareprovider 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 commitsuicide
• new or worsedepression
• new or worse anxiety
• feeling agitated orrestless
• panic attacks
• trouble sleeping(insomnia)
• new or worseirritability
• acting aggressive,being angry, or violent
• acting on dangerous impulses
• an extremeincrease in activity and talking (mania)
• other unusual changesin behavior or mood
Do not stop levetiracetam without first talking to a healthcare provider.
• Stopping levetiracetamsuddenly can cause serious problems. Stopping aseizure 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 checkfor other causes.
How canI 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-upvisits with your healthcare provideras scheduled.
• Call your healthcare providerbetween visits as needed, especially if you are worried about symptoms.
What is levetiracetam?
Levetiracetam is a prescription medicine taken by mouth that is used with other medicines to treat:• partial onset seizures in people 4 years ofage and older with epilepsy
• myoclonic seizures in people 12 years ofage and older with juvenile myoclonic epilepsy
• primary generalized tonic-clonic seizuresin people 6 years of age and older with certain types of generalized epilepsy.
It is not known iflevetiracetam is safe or effectivein children under 4 years ofage.
Before taking your medicine,make sure you have received the correctmedicine. Comparethe name above with the name on your bottle and the appearance of your medicine with the description of levetiracetamprovided below. Contact your pharmacist immediately if you believe a dispensing error may have occurred.
Levetiracetamtablets, 250 mg are blue coloured, oblong shaped, scored, film coated tabletsdebossed with ‘H’ on one side and ‘87’ on other side.
Levetiracetamtablets, 500 mg are yellow coloured, oblong shaped, scored, film coated tabletsdebossed with ‘H’ on one side and ‘88’ on other side.
Levetiracetamtablets, 750 mg are orange coloured, oblong shaped, scored, film coated tabletsdebossed with ‘H’ on one side and ‘90’ on other side.
Levetiracetamtablets, 1000 mg are white coloured, oblong shaped, scored, film coated tabletsdebossed with ‘H’ on one side and ‘91’ on other side.
What should I tell my healthcare provider beforestarting levetiracetam?
Before taking levetiracetam, 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 shouldtake levetiracetam while you are pregnant. If you become pregnant while taking levetiracetam, talk to your healthcare provider about registering with the NorthAmerican Antiepileptic Drug Pregnancy Registry. You can enroll in this registryby calling 1-888-233-2334. The purpose of this registry is tocollect information about the safety of levetiracetam and otherantiepileptic medicine during the pregnancy.
• are breast feeding.Levetiracetam can pass into your milk and may harm your baby. You and your healthcare provider should discusswhether you should take levetiracetam or breast-feed; you should not do both.
Tell your healthcare providerabout all the medicines you take, including prescription and nonprescription medicines,vitamins, and herbalsupplements. Do not start a new medicine without first talking with your healthcare provider.
Know the medicinesyou take. Keepa list of them to show your healthcare providerand pharmacist each time you get a new medicine.
How shouldI take levetiracetam?
Take levetiracetam exactly as prescribed.• Your healthcare provider will tell you how much levetiracetam to take and when to take it.Levetiracetam is usually taken twicea day. Take levetiracetam at the same times each day.
• Your healthcare providermay change your dose. Do not changeyour dose without talking to your healthcareprovider.
• Take levetiracetam with or without food.
• Swallow the tabletswhole. Do not chew or crush tablets.
• If you miss a dose of levetiracetam, take it as soon as you remember. If it is almost time foryour 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, call your local Poison Control Center or go to the nearest emergency room right away.
What should I avoid while taking levetiracetam?
Do not drive, operate machinery or do other dangerous activities until you know howlevetiracetam affects you. Levetiracetam maymake you dizzy or sleepy.
What are the possible side effects oflevetiracetam?
• See “What is the mostimportant information I should know about levetiracetam?”
Levetiracetam can cause serious side effects.
Call your healthcare provider right away if you haveany of these symptoms:
• moodand behavior changessuch as aggression, agitation, anger, anxiety, apathy,mood swings, depression, hostility,and irritability. A few people may get psychoticsymptoms such as hallucinations (seeing or hearing things that are really not there),delusions (false or strangethoughts or beliefs) and unusual behavior.
• extreme sleepiness, tiredness, and weakness
• problems with musclecoordination (problems walking andmoving)
The most common side effects seen in people whotake levetiracetam include:
• sleepiness
• weakness
• dizziness
• infection
The mostcommon side effects seen in childrenwho take levetiracetam include, in addition to those listed above:
• accidental injury
• irritability
• hostility
These side effects can happen at any time but happen more often within thefirst 4 weeks of treatment except forinfection.
Tell your healthcare provider if you have any sideeffect that bothers you or that does not go away.
These are not all the possible side effects of levetiracetam. For more information, ask your healthcareprovideror pharmacist.
Call your doctor for medical adviceabout side effects. You may reportside effects to FDA at 1-800-FDA-1088.
How should I store levetiracetam?
• Store levetiracetam at room temperature, 20°C to 25°C (68°F to 77°F) awayfrom heat and light.
• Keeplevetiracetam and all medicines out ofthe reach of children.
Generalinformation about levetiracetam.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use levetiracetam for a condition for which it was not prescribed.Do not give levetiracetam to other people,even if they have the same symptoms that you have. It may harmthem.
This Medication Guide summarizes the most important information about levetiracetam. If you would like more information,talk with your healthcare provider.You can ask your pharmacist orhealthcare provider for information about levetiracetam that is writtenfor health professionals.
What are the ingredientsof levetiracetam?
Levetiracetam tablet active ingredient: levetiracetam
Inactive ingredients: corn starch, croscarmellose sodium, povidone, colloidal silicon dioxide, talc, magnesium stearate and additional agents listed below:
500mg tablets: opadry II yellow (polyvinyl alcohol, titanium dioxide, polyethyleneglycol 3350, talc, iron oxide yellow)
750mg tablets: opadry II orange (polyvinylalcohol, titanium dioxide, polyethyleneglycol 3350, talc, FD&C yellow #6/sunset yellow FCF aluminum lake, ironoxide red)
1000mg tablets: opadry II white (polyvinyl alcohol, titanium dioxide, polyethyleneglycol 3350, talc)
Levetiracetamdoes not contain lactose or gluten.