What is the most important information I should know about SPRITAM?
Like other antiepileptic drugs, SPRITAM may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it.
Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• new or worse depression
• feeling agitated or restless
• trouble sleeping (insomnia)
• acting aggressive, being angry, or violent
• an extreme increase in activity or talking (mania)
• attempts to commit suicide
• new or worse anxiety
• panic attacks
• new or worse irritability
• acting on dangerous impulses
• other unusual changes in behavior or mood

Do not stop SPRITAM without first talking to a healthcare provider.

• Stopping SPRITAM 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 healthcare provider 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 healthcare provider as scheduled.
• Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

What is SPRITAM?

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

• myoclonic seizures in people 12 years of age and older with juvenile myoclonic epilepsy.
• primary generalized tonic-clonic seizures in people 6 years of age and older with certain types of generalized epilepsy.

It is not known if SPRITAM is safe or effective in children under:

• 4 years of age to treat partial-onset seizures
• 12 years of age to treat myoclonic seizures
• 6 years of age to treat primary generalized tonic-clonic seizures

SPRITAM is not recommended for children that weigh 20 kg (44 pounds) or less.

Before taking your medicine, make sure you have received the correct medicine. Compare the name above with the name on your package. Tell your pharmacist immediately if you think you have been given the wrong medicine.

Who should not take SPRITAM?

Do not take SPRITAM if you are allergic to levetiracetam.

What should I tell my healthcare provider before starting SPRITAM?

Before taking SPRITAM, tell your healthcare provider about all of your medical conditions, including if you:

• have or have had depression, mood problems or suicidal thoughts or behavior.
• have kidney problems.
• are pregnant or planning to become pregnant. It is not known if SPRITAM will harm your unborn baby. You and your healthcare provider will have to decide if you should take SPRITAM while you are pregnant. If you become pregnant while taking SPRITAM, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334 or go to http://www.aedpregnancyregistry.org. The purpose of the registry is to collect information about the safety of SPRITAM and other antiepileptic medicine during pregnancy.
• are breastfeeding or plan to breastfeed. SPRITAM can pass into your breast milk. It is not known if the SPRITAM that passes into your breast milk can harm your baby. Talk to your doctor about the best way to feed your baby while you receive SPRITAM.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not start a new medicine without first talking with your healthcare provider.

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 SPRITAM?

• Take SPRITAM exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how much SPRITAM to take and when to take it. SPRITAM is usually taken 2 times each day.
• Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
• As a main way to take SPRITAM, it is intended to disintegrate in your mouth when taken with a sip of liquid.
• Alternately, SPRITAM may be taken by adding the whole tablet to a small volume of liquid in a cup.
  • How to take SPRITAM with a sip of liquid:
    • Take SPRITAM as shown on the SPRITAM carton (box).
    • Make sure your hands are dry before you remove the SPRITAM tablet(s).
    • Peel the foil away from the blister. Do not push the tablet(s) through the foil packaging.
    • Peel the foil away from the blister by bending up and lifting the peel tab around the blister seal.
    • Empty the tablet into your dry hand.
    • Place the SPRITAM tablet on your tongue and follow with a sip of liquid. Let the tablet disintegrate all the way on your tongue before swallowing.
    • SPRITAM disintegrates in an average time of 11 seconds (ranging from 2 to 27 seconds) in the mouth when taken with a sip of liquid.
  • How to take SPRITAM with a small volume of liquid in a cup:
    • Make sure your hands are dry before you remove the SPRITAM tablet(s).
    • Peel the foil away from the blister. Do not push the tablet through the foil packaging.
    • Peel the foil away from the blister by bending up and lifting the peel tab around the blister seal.
    • Add whole SPRITAM tablet(s) to a small volume of liquid in a cup (1 tablespoon or enough to cover the medicine), and swirl gently.
    • Swallow right after the tablet(s) disintegrates.
    • If there is any medicine left in the cup, add a small volume of liquid to the cup, swirl gently, and swallow the liquid.
• SPRITAM can be taken with or without food.
• If you take too much SPRITAM, call your Poison Control Center at 1-800-222-1222 or go to the nearest emergency room right away.
• As shown on the SPRITAM carton (box), do not push the tablet through foil. The foil should be peeled away from the blister. Bend up and lift the peel tab, pulling open the seal around the blister.

What should I avoid while taking SPRITAM?

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

What are the possible side effects of SPRITAM?

• See "What is the most important information I should know about SPRITAM?"

SPRITAM can cause serious side effects.
Call your healthcare provider right away if you have any of these symptoms:

• 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.
• extreme sleepiness, tiredness, and weakness.
• allergic reactions such as swelling of the face, lips, eyes, tongue, and throat, trouble swallowing or breathing, and hives.
• a skin rash. 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.
• a serious allergic reaction that may affect your skin or other parts of your body such as your liver, kidneys, heart, or blood cells. This allergic reaction can be life-threatening and can cause death, particularly if it is not treated as early as possible. Call your healthcare provider right away if you have:
  • a skin rash
  • swelling of your face
  • dark urine
  • fever or swollen glands that do not go away
  • shortness of breath
  • yellowing of the skin or whites of the eyes
• problems with muscle coordination (problems walking and moving).

The most common side effects seen in adults who take SPRITAM include:

• sleepiness
• infection
• weakness
• dizziness

The most common side effects seen in children who take SPRITAM include the side effects above and:

• tiredness
• decreased appetite
• irritability
• acting aggressive
• nasal congestion

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of SPRITAM. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to Aprecia Pharmaceuticals, LLC at 1-844-882-7732 or FDA at 1-800-FDA-1088.

How should I store SPRITAM?

• Store SPRITAM at room temperature, between 59°F to 86°F (15°C to 30°C).
• Keep SPRITAM and all medicines out of the reach of children.

General information about the safe and effective use of SPRITAM.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SPRITAM for a condition for which it was not prescribed. Do not give SPRITAM to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about SPRITAM that is written for health professionals. You can also get information about SPRITAM at 1-844-882-7732.

What are the ingredients in SPRITAM?

Active ingredient: levetiracetam

Inactive ingredients: colloidal silicon dioxide, glycerin, mannitol, microcrystalline cellulose, polysorbate 20, povidone, sucralose, butylated hydroxyanisole, and natural and artificial spearmint flavor.

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.

Patent(s): www.aprecia.com/patents

©2023 Aprecia Pharmaceuticals, LLC all rights reserved. Printed in the USA