SPRITAM is manufactured with US-sourced levetiracetam by Aprecia Pharmaceuticals, LLC in Blue Ash, Ohio USA. The manufacturing facility is the first and only in the world to receive FDA authorization to produce a three-dimensionally printed pharmaceutical product for commercial sale in the United States.

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SPRITAM® Important Safety Information

SPRITAM® (levetiracetam) tablets, for oral suspension

Indications and Usage

SPRITAM (levetiracetam) is a prescription medicine taken by mouth that is used to treat partial-onset seizures in people 4 years of age and older. SPRITAM is also used with other medicines to treat 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 more than 20 kg (44 lbs).

Important Safety Information

SPRITAM may not be for everyone. Ask your healthcare provider if SPRITAM is right for you. Do not take SPRITAM if you are allergic to levetiracetam.

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.

SPRITAM can cause severe allergic reactions after the first dose or at any time during treatment. Discontinue SPRITAM and seek immediate medical attention if you have allergic reactions such as swelling of the face, lips, eyes, tongue and throat, trouble swallowing or breathing, and hives.

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 at the first sign of rash.

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, which is 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 adults 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. To report SUSPECTED ADVERSE REACTIONS, contact Aprecia Pharmaceuticals, LLC at 1-844-882-7732.

Administration

SPRITAM is intended to disintegrate in the mouth when taken with a sip of liquid. As a main way to take SPRITAM, 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.

Manufactured by Aprecia Pharmaceuticals, LLC, Blue Ash, OH 45242 USA Distributed by Prasco, LLC, Mason, OH 45040 USA

SPRITAM® is a registered trademark of Aprecia Pharmaceuticals, LLC.
© 2021 Prasco LLC all rights reserved.

LB-SI-0001.G
Revised 3/2021