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KEPPRA XR™
(pronounced KEPP-ruh XR)
(levetiracetam) 500 mg and 750 mg extended-release tablets

Read the Patient Information that comes with KEPPRA XR (levetiracetam extended-release tablets) before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your condition or your treatment.

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 KEPPRA XR (levetiracetam extended-release tablets) provided below. Contact your pharmacist immediately if you believe a dispensing error may have occurred.

500 mg KEPPRA XR (levetiracetam extended-release tablets) tablets are white, oblong-shaped, film-coated tablets marked with “UCB 500XR” in red on one side. 750 mg KEPPRA XR (levetiracetam extended-release tablets) tablets are white, oblong-shaped, film-coated tablets marked with “UCB 750XR” in red on one side.

What is KEPPRA XR (levetiracetam extended-release tablets) ?

KEPPRA XR (levetiracetam extended-release tablets) is a medicine taken by mouth once daily that is used with other medicines to treat partial onset seizures in patients 16 years of age and older with epilepsy.

What should I tell my healthcare provider before starting KEPPRA XR (levetiracetam extended-release tablets) ?

Tell your healthcare provider about all of your medical conditions, including if you:

• have kidney disease. You may need a lower dose of KEPPRA XR (levetiracetam extended-release tablets) .
• are pregnant or planning to become pregnant. It is not known if KEPPRA XR can harm your unborn baby. If you use KEPPRA XR (levetiracetam extended-release tablets) while you are pregnant, ask your healthcare provider about being in the UCB AED Pregnancy Registry. You can join this registry by calling (888) 537-7734 (toll free). You may also join the North American Antiepileptic Drug Pregnancy Registry by calling (888) 233-2334 (toll free).
• are breast feeding. KEPPRA XR (levetiracetam extended-release tablets) can pass into your milk and may harm your baby. You should choose to either take KEPPRA XR (levetiracetam extended-release tablets) or breast feed, but not both.

Tell your healthcare provider about all the medicines you take, including prescription, nonprescription, vitamins, and herbal supplements. Tell your healthcare provider about any allergies you may have.

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 KEPPRA XR (levetiracetam extended-release tablets) ?

• Take KEPPRA XR (levetiracetam extended-release tablets) exactly as prescribed. KEPPRA XR (levetiracetam extended-release tablets) is usually taken once a day. Take KEPPRA XR (levetiracetam extended-release tablets) at the same time each day.
• Your healthcare provider may start you on a lower dose of KEPPRA XR (levetiracetam extended-release tablets) and increase it as your body gets used to the medicine.
• Take KEPPRA XR (levetiracetam extended-release tablets) with or without food. Swallow the tablets whole. Do not chew, break, or crush tablets.
• If you miss a dose of KEPPRA XR (levetiracetam extended-release tablets) , do not double your next dose to make up for the missed dose. If it has only been a few hours since your missed dose, take KEPPRA XR (levetiracetam extended-release tablets) as soon as you remember then return to your regular schedule. If it is almost time for the next dose, skip the missed dose and resume your regular schedule. Talk with your healthcare provider for more detailed instructions.
• If you take too much KEPPRA XR (levetiracetam extended-release tablets) or overdose, call your local Poison Control Center or emergency room right away.
• Do not stop taking KEPPRA XR (levetiracetam extended-release tablets) or any other seizure medicine unless your healthcare provider told you to. Stopping a seizure medicine all at once can cause seizures that will not stop (status epilepticus), a very serious problem.
• Tell your healthcare provider if your seizures get worse or if you have any new types of seizures.

What should I avoid while taking KEPPRA XR (levetiracetam extended-release tablets) ?

Do not drive, operate machinery or do other dangerous activities until you know how KEPPRA XR (levetiracetam extended-release tablets) affects you. KEPPRA XR (levetiracetam extended-release tablets) may make you dizzy or sleepy.

What are the possible side effects of KEPPRA XR (levetiracetam extended-release tablets) ?

KEPPRA XR (levetiracetam extended-release tablets) may cause the following serious problems:

• extreme sleepiness and dizziness
• behavior changes such as irritability and aggression

In addition, the following serious problems have been seen with other formulations of KEPPRA:

• extreme sleepiness, tiredness, and weakness
• problems with muscle coordination (problems walking and moving)
• 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. A few people may get thoughts of suicide (thoughts of killing yourself).

Call your healthcare provider right away if you get any of these symptoms.

The most common side effects with KEPPRA XR (levetiracetam extended-release tablets) are:

• sleepiness
• irritability

These side effects could happen at any time but happen most often within the first four weeks of treatment.

These are not all the side effects of KEPPRA XR (levetiracetam extended-release tablets) . For more information, ask your healthcare provider or pharmacist. If you get any side effects that concern you, call your healthcare provider.

How should I store KEPPRA XR (levetiracetam extended-release tablets) ?

• Store KEPPRA XR (levetiracetam extended-release tablets) at room temperature away from heat and light.
• Keep KEPPRA XR (levetiracetam extended-release tablets) and all medicines out of the reach of children.

General information about KEPPRA XR (levetiracetam extended-release tablets) .

Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use KEPPRA XR (levetiracetam extended-release tablets) for a condition for which it was not prescribed. Do not give your KEPPRA XR (levetiracetam extended-release tablets) to other people, even if they have the same symptoms that you have. It may harm them.

This leaflet summarizes the most important information about KEPPRA XR (levetiracetam extended-release tablets) . If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about KEPPRA XR (levetiracetam extended-release tablets) that is written for healthcare professionals.

What are the ingredients of KEPPRA XR?

KEPPRA XR tablets contain the labeled amount of levetiracetam. Inactive ingredients: colloidal anhydrous silica, hypromellose, magnesium stearate, polyethylene glycol 6000, polyvinyl alcohol-partially hydrolyzed, titanium dioxide (E171), Macrogol/PEG3350, and talc. The imprinting ink contains shellac, FD&C Red #40, n-butyl alcohol, propylene glycol, titanium dioxide, ethanol, and methanol.

KEPPRA XR (levetiracetam extended-release tablets) does not contain lactose or gluten.

This patient leaflet has been approved by the US Food and Drug Administration.

Last reviewed on RxList: 3/13/2009
This monograph has been modified to include the generic and brand name in many instances.