PATIENT INFORMATION

Levetiracetam Tablets
1000 mg

Read the Patient Information that comes with Levetiracetam 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 Levetiracetam Tablets provided below. Contact your pharmacist immediately if you believe a dispensing error may have occurred.

1000 mg Levetiracetam Tablets are white to off-white, film-coated, modified oval, biconvex tablets with “LE" score "1000” on one side and “>” on the other side.

What is Levetiracetam?

Levetiracetam is a medicine taken by mouth that is used with other medicines to treat:

• partial onset seizures in patients 4 years of age and older with epilepsy

Who should not take Levetiracetam Tablets?

Do not take Levetiracetam Tablets if you are allergic to any of its ingredients. The active ingredient is levetiracetam. See the end of this leaflet for a list of all the ingredients in Levetiracetam Tablets.

What should I tell my healthcare provider before starting Levetiracetam Tablets?

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

• have kidney disease.You may need a lower dose of Levetiracetam Tablets.
• are pregnant or planning to become pregnant. It is not known if Levetiracetam Tablets can harm your unborn baby. You can join the North American Antiepileptic Drug Pregnancy Registry by calling (888) 233-2334 (toll free).
• are breast feeding. Levetiracetam Tablets can pass into your milk and may harm your baby. You should choose to either take Levetiracetam Tablets or breast feed, but not both.

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

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 Levetiracetam Tablets?

• Take Levetiracetam Tablets exactly as prescribed. Levetiracetam Tablets is usually taken twice a day. Once in the morning and once at night. Take Levetiracetam Tablets at the same times each day.
• Your healthcare provider may start you on a lower dose of Levetiracetam Tablets and increase it as your body gets used to the medicine.
• Take Levetiracetam Tablets with or without food. Swallow the tablets whole. Do not chew or crush tablets. Use the KEPPRA oral solution if you cannot swallow tablets. Use a medicine dropper or medicine cup to measure KEPPRA oral solution. Do not use a teaspoon. Ask your pharmacist for a medicine dropper or medicine cup to help you measure KEPPRA. If your healthcare provider has given you KEPPRA oral solution, be sure to ask your pharmacist for a medicine syringe to help you measure the correct amount of KEPPRA oral solution. Ask your pharmacist for instructions on how to properly use the medicine syringe or dosing device that has been provided to you.
• If you miss a dose of Levetiracetam 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 Levetiracetam 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 Levetiracetam Tablets or overdose, call your local Poison Control Center or emergency room right away.
• Do not stop taking Levetiracetam Tablets or any other seizure medicine unless your healthcare provider told you to. Stopping a seizure medicine all at once can cause status epilepticus (seizures that will not stop), 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 Levetiracetam Tablets?

Do not drive, operate machinery or other dangerous activities until you know how Levetiracetam Tablets affects you. Levetiracetam Tablets may make you dizzy or sleepy.

What are the possible side effects of Levetiracetam Tablets?

Adults

Levetiracetam Tablets may cause the following serious problems in adults. Call your healthcare provider right away if you get any of the following symptoms:

• 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).

The most common side effects with Levetiracetam Tablets in adults are:

• sleepiness
• weakness
• dizziness
• infection

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

Children

Levetiracetam Tablets may cause the following serious problems in children. Call your child’s healthcare provider right away if they get any of the following symptoms:

• extreme sleepiness, tiredness, and weakness
• mood and behavior changes such as aggression, agitation, anger, anxiety, apathy, depression, hostility, and irritability

The most common side effects with Levetiracetam Tablets in children, in addition to those seen in adults are:

• sleepiness
• accidental injury
• hostility
• irritability
• weakness

These side effects could happen at any time.

These are not all the side effects of Levetiracetam 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 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 conditions other than those described in patient information leaflets. Do not use Levetiracetam Tablets for a condition for which it was not prescribed. Do not give your Levetiracetam 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 Levetiracetam Tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Levetiracetam Tablets that is written for healthcare professionals.

What are the ingredients of Levetiracetam Tablets?

Levetiracetam Tablets contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, magnesium stearate, povidone, starch, talc, polyvinyl alcohol, titanium dioxide, and macrogol/polyethylene glycol 3350.

Levetiracetam Tablets do not contain lactose.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA 1088.

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

Rx only

Manufactured by: Mississauga, Canada L5N 2B8

Manufactured for: Cobalt Laboratories, Bonita Springs, Florida, U.S.A., 34134

Item Number: 104-029-01

Date: December 2008