• LIBERVANT is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death. Get emergency help right away if any of the following happens:
  ◦ shallow or slowed breathing,
  ◦ breathing stops (which may lead to the heart stopping),
  ◦ excessive sleepiness (sedation).

• Risk of abuse, misuse, and addiction. LIBERVANT is used in children 2 to 5 years of age. The unapproved use of LIBERVANT has a risk for abuse, misuse, and addiction, which can lead to overdose and serious side effects including coma and death.
  ◦ Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including diazepam (the active ingredient in LIBERVANT). These serious side effects may also includedelirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your child’s healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.
  ◦ Your child can develop an addiction even if your child takes LIBERVANT as prescribed by your child’s healthcare provider.
  ◦ Give LIBERVANT exactly as your child’s healthcare provider prescribed.
  ◦ Do not share LIBERVANT with other people.
  ◦  Keep LIBERVANT in a safe place and away from children.
• Physical dependence and withdrawal reactions. LIBERVANT is intended for use if needed in order to treat higher than usual seizure activity. Benzodiazepines, including LIBERVANT, can cause physical dependence and withdrawal reactions, especially if used daily. LIBERVANT is not intended for daily use.
  ◦ Do not suddenly stop giving LIBERVANT to your child without talking to your child’s healthcare provider. Stopping LIBERVANT suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures that will not stop (status epilepticus), sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, homicidal thoughts, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your child’s healthcare provider or go to the nearest hospital emergency room right away if your child gets any of these symptoms.
  ◦ Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months including,anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning, or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.
  ◦Physical dependence is not the same as drug addiction. Your child’s healthcare provider can tell you more about the differences between physical dependence and drug addiction.
  ◦ Do not give your child more LIBERVANT than prescribed or give LIBERVANT more often than prescribed.

• LIBERVANT can make your child sleepy or dizzy and can slow your child’s thinking and motor skills.
  ◦ Do not allow your child to drive a motor vehicle, operate machinery, or ride a bicycle until you know how LIBERVANT affects your child.
  ◦ Do not give other drugs that may make your child sleepy or dizzy while taking LIBERVANT without first talking to your child’s healthcare provider. When taken with drugs that cause sleepiness or dizziness, LIBERVANT may make your child’s sleepiness or dizziness much worse.

• thoughts about suicide or dying

• attempts to commit suicide

• new or worse depression

• new or worse anxiety or irritability      

• feeling agitated or restless

• an extreme increase in activity and talking (mania)

• trouble sleeping (insomnia)

• acting aggressive, being angry or violent

• new or worse panic attacks

• other unusual changes in behavior or mood

• acting on dangerous impulses

• Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your child’s healthcare provider as scheduled.

• LIBERVANT is a prescription medicine used for the short-term treatment of seizure clusters (also known as “acute repetitive seizures”) that are different from a person’s usual seizure pattern in people 2 to 5 years of age.

• is allergic to diazepam or any of the ingredients in LIBERVANT. See the end of this Medication Guide for a complete list of ingredients in LIBERVANT.
• has an eye problem called acute narrow angle glaucoma.

• has a history of depression, mood problems, or suicidal thoughts or behavior.
• has liver or kidney problems.
• has asthma, emphysema, bronchitis, chronic obstructive pulmonary disease, or other breathing problems.

• Read the Instructions for Use that comes with this Medication Guide for detailed information about the right way to give LIBERVANT.
• Give LIBERVANT exactly as your child’s healthcare provider tells you to.
• Do not change your child’s dosage unless your child’s healthcare provider tells you to change it.
• To give LIBERVANT:
  ◦ You as the caregiver must be able to tell the difference between cluster seizures and ordinary seizures.
  ◦ You as the caregiver must be comfortable in your ability to give LIBERVANT as instructed by your child’s healthcare provider and as instructed in the Instructions for Use at the end of this Medication Guide.
  ◦ You as the caregiver must understand your child’s healthcare provider’s instructions about when to use LIBERVANT.
• Your child’s healthcare provider will tell you:
  ◦ what seizure clusters are,
  ◦ exactly how much LIBERVANT to give to your child,
  ◦ when to give LIBERVANT,
  ◦ how to give LIBERVANT,
  ◦ what to do after you give LIBERVANT if the seizures do not stop or there is a change in breathing, behavior, or condition that worries you.
• Your child’s healthcare provider should show you how to give LIBERVANT the right way.
• You should carry LIBERVANT with you in case you need to give it to treat your child’s seizure clusters.
• Before a seizure cluster happens, family members, caregivers, and other people who may have to give LIBERVANT should know where you keep your LIBERVANT and how to give LIBERVANT.
• Each LIBERVANT comes in a sealed foil pouch. Do not open the foil pouch until you are ready to use it.
• Do not split LIBERVANT. The entire film should be placed on the inside of the cheek.
• Allow LIBERVANT to dissolve. Do not chew or swallow the film.
• Do not take with liquids.
• LIBERVANT can be taken with or without food.
• What should I do after LIBERVANT has been given:
  ◦ Note the time LIBERVANT was given and changes in the resting breathing rate.
  ◦ Your child’s healthcare provider may prescribe a second dose of LIBERVANT.
  ◦ If a second dose is needed, it may be given at least 4 hours after the first dose of LIBERVANT film is given.
  ◦ Do not give more than 2 doses of LIBERVANT to treat a seizure cluster.                                                                                                                                        
  ◦ Do not give a second dose of LIBERVANT if:

• Do not use LIBERVANT for:
  ◦ more than 1 seizure cluster episode every 5 days and
  ◦ more than 5 episodes each month.
• Talk to your child’s healthcare provider about slowly stopping LIBERVANT to avoid withdrawal symptoms.
• If you give too much LIBERVANT, call your child’s healthcare provider or go to the nearest hospital emergency room right away.

• See “What is the most important information I should know about LIBERVANT?”

• sleepiness
• headache

These are not all the possible side effects of LIBERVANT.

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

• Store LIBERVANT at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep LIBERVANT in the foil pouch until ready to use.
• Keep LIBERVANT and all medicines out of the reach of children.