Safety

What is the most important information I should know about Keppra XR®?
Like other antiepileptic drugs, Keppra XR® may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it.

Call a doctor 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 Keppra XR® without first talking to a doctor.

  • Stopping Keppra XR® 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 doctor 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 doctor as scheduled.
  • Call your doctor between visits as needed, especially if you are worried about symptoms.

What should I tell my neurologist before starting Keppra XR®?
Tell your neurologist about all of your medical conditions, including if you:

  • have or have had depression, mood problems or suicial thoughts or behavior.
  • have kidney problems.
  • are pregnant or planning to become pregnant. It is not known if Keppra XR® will harm your unborn baby. If you become pregnant while taking Keppra XR®, talk to your doctor about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. You can also enroll in the UCB AED Pregnancy Registry by calling 1-888-537-7734. The purpose of these registries is to collect information about the safety of Keppra XR® and other antiepileptic medicine during pregnancy.
  • are breast feeding. Keppra XR® can pass into your milk and may harm your baby. You and your doctor should discuss whether you should take Keppra XR® or breast feed; you should not do both.

Tell your neurologist 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 doctor.

Know the medicines you take. Keep a list of them to show your neurologist and pharmacist each time you get a new medicine.

What should I avoid while taking Keppra XR®?
Do not drive, operate machinery, or do other dangerous activities until you know how Keppra XR® affects you. Keppra XR® may make you dizzy or sleepy.

General information about Keppra XR®.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Keppra XR® for a condition for which it was not prescribed. Do not give Keppra XR® to other people, even if they have the same symptoms that you have. It may harm them.

Next: Side Effects

IMPORTANT SAFETY INFORMATION

Keppra XR® is a prescription medicine that is used with other medicines to treat partial onset seizures in people 16 years of age and older with epilepsy.

Keppra XR® is generally well-tolerated, but may not be for everyone. Ask your doctor if Keppra XR® is right for you. Like other antiepileptic drugs, Keppra XR® may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it. Patients should call their healthcare provider right away if they have depression, mood problems, or suicidal thoughts or behavior while taking Keppra XR®. Keppra XR® may cause extreme sleepiness, tiredness, and weakness, and problems with muscle coordination. Keppra XR® may also cause mood and behavior changes including psychotic symptoms such as hallucinations, delusions, and unusual behavior. Call your healthcare provider right away if you have any of these symptoms. The most common side effects seen with Keppra XR® and other formulations of Keppra® include sleepiness, weakness, dizziness, and infection. Do not stop taking Keppra XR® unless instructed by your healthcare provider. Stopping a seizure medication all at once can cause seizures that will not stop, a very serious problem. Call your doctor for medical advice about side effects. You may also report side effects to FDA at 1-800-FDA-1088 or go to www.fda.gov/medwatch or contact UCB, Inc. at 1-866-822-0068.

Please see Keppra XR® Medication Guide and Full Prescribing Information for additional important patient information.

*With this coupon, you pay the first $25 of your Keppra XR® or Keppra® co-pay and we pay your remaining out-of-pocket expense up to a maximum of $30. This coupon may not be reproduced and must accompany a valid, signed Keppra XR® prescription. No cash value. Offer not valid for prescriptions reimbursed or paid under any government health insurance program (e.g., Medicaid, Medicare) or any private payer in Massachusetts or where otherwise prohibited by law. Patients are responsible for reporting this rebate to any private insurer that covers any part of the prescription. Offer expires on 12/31/12. UCB may cancel or alter this program at any time without notice.