MEDICATION GUIDE

Patient should be instructed to take extended-release levetiracetam tablets only as prescribed.

Levetiracetam Extended-Release Tablets

Read this Medication Guide before you start taking extended-release 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 extended-release levetiracetam tablets?

Like other antiepileptic drugs, extended-release 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 extended-release levetiracetam tablets without first talking to a healthcare provider.

Stopping extended-release 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 schedule

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

What are extended-release levetiracetam tablets?

Extended-release levetiracetam tablet is a prescription medicine taken by mouth that is used with other medicines to treat partial onset seizures in people 16 years of age and older with epilepsy.

It is not known if extended-release levetiracetam tablets are safe or effective in people under 16 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 extended-release levetiracetam tablets provided below.

Tell your pharmacist immediately if you think you have been given the wrong medicine.

500 mg levetiracetam extended-release tablets are white, oblong-shaped, film-coated extended-release tablets debossed with "500" on one side and plain on the other side.

750 mg levetiracetam extended-release tablets are white, oblong-shaped, film-coated extended-release tablets debossed with "750" on one side and plain on the other side. 

What should I tell my healthcare provider before starting extended-release levetiracetam tablets?

Before taking extended-release 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 extended-release levetiracetam tablets will harm your unborn baby. You and your healthcare provider will have to decide if you should take extended-release levetiracetam tablets while you are pregnant. If you become pregnant while taking extended-release 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 the registry is to collect information about the safety of extended-release 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 extended-release 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 extended-release levetiracetam tablets?

Take extended-release levetiracetam tablets exactly as prescribed.

Your healthcare provider will tell you how much extended-release levetiracetam tablets to take and when to take it. Extended-release levetiracetam tablets are usually taken once a day. Take extended-release levetiracetam tablets at the same time each day.

Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.

Take extended-release levetiracetam tablets with or without food.

Swallow the tablets whole. Do not chew, break, or crush tablets.

If you miss a dose of extended-release 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 extended-release levetiracetam tablets, call your local Poison Control Center or go to the nearest emergency room right away.

What should I avoid while taking extended-release levetiracetam tablets?

Do not drive, operate machinery or do other dangerous activities until you know how extended-release levetiracetam tablets affect you.  Extended-release levetiracetam tablets may make you dizzy or sleepy.

What are the possible side effects of extended-release levetiracetam tablets?

See “What is the most important information I should know about extended-release levetiracetam tablets?”

Extended-release 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)

Common side effects seen in people who take extended-release levetiracetam tablets and other formulations of levetiracetam include:

• sleepiness
  
• weakness
  
• dizziness
  
• infection

These side effects can happen at any time but happen more often within the first 4 weeks of treatment.

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 extended-release levetiracetam tablets. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may also report side effects to Quinn Pharmaceuticals at 1-844-477-8466 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

How should I store extended-release levetiracetam tablets?

• Store extended-release levetiracetam tablets at room temperature, 20 to 25ºC (68 to 77ºF) [see USP Controlled Room Temperature] away from heat and light.
  
• Keep extended-release levetiracetam tablets and all medicines out of the reach of children.

General information about extended-release levetiracetam tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use extended-release levetiracetam tablets for a condition for which it was not prescribed. Do not give extended-release 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 extended-release levetiracetam tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about extended-release levetiracetam tablets that is written for health professionals.

What are the ingredients of extended-release levetiracetam tablets?

Levetiracetam extended-release tablet active ingredient: levetiracetam

Inactive ingredients: cetostearyl alcohol, compressible sugar, copovidone, talc, polyvinyl alcohol-polyethylene glycol copolymer, magnesium stearate, colloidal silicon dioxide, titanium dioxide, kaolin, sodium lauryl sulfate, carnauba wax.

USP Dissolution Test pending.

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

Rx only