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 this medicine 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.

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 this medicine 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.

• Take Spritam exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how much 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 product carton (box).
    • Make sure your hands are dry before you remove the 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 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 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 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 or overdose, call your Poison Control Center at 1-800-222-1222 or go to the nearest emergency room right away.
• As shown on the 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.

Usual Adult and Pediatric Dosage for Partial-Onset Seizures (monotherapy or adjunctive therapy)

- Adults/pediatric patients 4 years and older weighing over 40 kg: 500 mg twice daily; increase as needed/tolerated by 500 mg twice daily every 2 weeks to a maximum recommended dose of 1500 mg twice daily
- Pediatric patients 4 years and older weighing 20 to 40 kg: 250 mg twice daily; increase by 250 mg twice daily every two weeks to a maximum of 750 mg twice daily
 
- Use: treatment of partial-onset seizures in patients 4 years of age and older weighing more than 20 kg 

Usual Adult and Pediatric Dosage for Myoclonic Seizures

- Adults/pediatric patients 12 years and older:  500 mg twice daily; increase by 500 mg twice daily every 2 weeks to recommended dose of 1500 mg twice daily

- Use: treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy

Usual Adult and Pediatric Dosage for Primary Generalized Tonic-Clonic Seizures

- Adults/pediatric patients 6 years and older weighing over 40 kg: 500 mg twice daily; increase as needed/tolerated by 500 mg twice daily every 2 weeks to a maximum recommended dose of 1500 mg twice daily
- Pediatric patients 6 years and older weighing 20 to 40 kg: 250 mg twice daily; increase by 250 mg twice daily every 2 weeks to a maximum of 750 mg twice daily

- Use: treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy 

Do not take Spritam if you are allergic to levetiracetam.

Before taking Spritam

Before you start treatment, 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 during treatment, 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 during treatment.

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

See Important information.

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.
• problems with muscle coordination (problems walking and moving).

The most common side effects seen in adults include:

• sleepiness
• infection
• weakness
• dizziness

The most common side effects seen in children 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. 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.

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.