Important Safety Information

Indications and Usage

SPRITAM (levetiracetam) is a prescription 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, myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures in patients 6 years of age and older with certain types of generalized epilepsy. SPRITAM is recommended for use in patients weighing 20 kg (44 lbs) or more.

SPRITAM (levetiracetam) is a prescription medicine taken by mouth that is used with other medicines to treat partial onset seizures in people 4 years of age and older with epilepsy, myoclonic seizures in people 12 years of age and older with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures in people 6 years of age and older with certain types of generalized epilepsy. SPRITAM is recommended for use in people weighing 20 kg (44 lbs) or more.

Important Safety Information

SPRITAM may not be for everyone. Ask your healthcare provider if SPRITAM is right for you.

Warnings and Precautions

Antiepileptic drugs, including SPRITAM, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you have new or worsening symptoms of depression, any unusual changes in mood or behavior, or suicidal thoughts, behavior, or thoughts about self-harm that you have never had before or may be worse than before.

SPRITAM may cause extreme sleepiness, tiredness, and weakness, and problems with muscle coordination. You should not drive, operate machinery or do other dangerous activities until you know how SPRITAM affects you.

Serious skin rashes can happen after you start taking SPRITAM. There is no way to tell if a mild rash will become a serious reaction. Call your healthcare provider right away if you get a rash while taking SPRITAM.

Do not stop taking SPRITAM unless instructed by your healthcare provider. Stopping a seizure medication suddenly can cause you to have seizures more often or seizures that will not stop, a very serious problem. If you become pregnant or intend to become pregnant, contact your healthcare provider right away.

Common Adverse Reactions

In clinical trials, the most common side effects seen in people who take SPRITAM include sleepiness, weakness, dizziness, and infection. In addition to those previously listed, the most common side effects seen in children who take SPRITAM include tiredness, acting aggressive, nasal congestion, decreased appetite, and irritability.

Talk to your healthcare provider about other possible side effects with SPRITAM. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Administration

SPRITAM is intended to disintegrate in the mouth when taken with a sip of liquid. As a primary method of administration, place a tablet on the tongue with a dry hand, and then take a sip of liquid. SPRITAM should be swallowed only after the tablet disintegrates in the mouth. SPRITAM should not be swallowed intact. Partial tablet(s) should not be administered.

Alternately, add whole SPRITAM tablet(s) to a small volume of liquid in a cup and swirl gently. Swallow right after the tablet(s) disintegrate. If there is any medicine left in the cup, rinse with a small volume of liquid, swirl and swallow the remaining contents.

For additional safety information, please see US Full Prescribing Information and Medication Guide. This information does not take the place of talking with your healthcare provider about your condition or your treatment.

Important Safety Information

SPRITAM may not be for everyone.

Warnings and Precautions

Antiepileptic drugs, including SPRITAM, may cause suicidal thoughts or actions in a very small number of patients, about 1 in 500. Advise patients to contact you right away if they experience new or worsening symptoms of depression, any unusual changes in mood or behavior, or suicidal thoughts, behavior, or thoughts about self harm they have never had before or which may be worse than before.

SPRITAM may cause extreme sleepiness, tiredness, and weakness, and problems with muscle coordination. Patients should be instructed not to drive, operate machinery or do other dangerous activities until they know how SPRITAM affects them.

Serious skin rashes can occur after your patients start taking SPRITAM. There is no way to tell if a mild rash will become a serious reaction. Instruct patients to contact you right away if they develop a skin rash.

Advise patients not to stop SPRITAM unless instructed by you. Stopping a seizure medication suddenly can cause more frequent seizures or seizures that will not stop. Instruct patients to contact you right away if they become pregnant or intend to become pregnant.

Common Adverse Reactions

In clinical trials, the most common side effects seen in patients who take SPRITAM include sleepiness, weakness, dizziness, and infection. In addition to those previously listed, the most common side effects seen in children who take SPRITAM include tiredness, acting aggressive, nasal congestion, decreased appetite, and irritability.

You can report adverse reactions of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Administration

SPRITAM is intended to disintegrate in the mouth when taken with a sip of liquid. As a primary method of administration, instruct patients to place a tablet on their tongue with a dry hand, and then take a sip of liquid. SPRITAM should be swallowed only after the tablet disintegrates in the mouth. SPRITAM should not be swallowed intact. Partial tablet(s) should not be administered.

Alternately, patients can add whole SPRITAM tablet(s) to a small volume of liquid in a cup, swirl gently and swallow immediately after the tablet(s) disintegrate. If there is any medicine left in the cup, instruct patients to rinse with a small volume of liquid, swirl and swallow the remaining contents.

For additional safety information, please see US Full Prescribing Information and Medication Guide.