Learn about SYMPAZAN^®

Important Safety Information

What is SYMPAZAN^®?

SYMPAZAN (clobazam) oral film, CIV is a prescription medicine used along with other medicines to treat seizures associated with Lennox-Gastaut Syndrome in people 2 years of age or older. It is not known if SYMPAZAN is safe and effective in children less than 2 years old.

IMPORTANT SAFETY INFORMATION for SYMPAZAN

What is the most important information I should know about SYMPAZAN?

SYMPAZAN 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)

Do not drive or operate heavy machinery until you know how taking SYMPAZAN with opioids affects you.

Risk of abuse, misuse, and addiction. There is a risk for abuse, misuse, and addiction with benzodiazepines, including SYMPAZAN treatment, 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 SYMPAZAN. These serious side effects may also include delirium (severe state of confusion), paranoia, suicidal thoughts or actions, seizures, and difficulty breathing.
  Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.
• You can develop an addiction even if you take SYMPAZAN as prescribed by your healthcare provider.
• Take SYMPAZAN exactly as your healthcare provider prescribed.
• Do not share your SYMPAZAN with other people.
• Keep SYMPAZAN in a safe place and away from children.

Physical dependence and withdrawal reactions. SYMPAZAN can cause physical dependence and withdrawal reactions, especially if you continue to take SYMPAZAN for several days to several weeks.

• Do not suddenly stop taking SYMPAZAN. Stopping SYMPAZAN suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions.
  Call your healthcare provider or go to the nearest hospital emergency room right away if you get 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 healthcare provider can tell you more about the differences.
• Do not take more SYMPAZAN than prescribed or take SYMPAZAN for longer than prescribed.

SYMPAZAN can make you sleepy or dizzy and can slow your thinking and motor skills.

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how SYMPAZAN affects you.

Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking SYMPAZAN without first talking to your healthcare provider.

• When taken with alcohol or drugs that cause sleepiness or dizziness, SYMPAZAN may make your sleepiness or dizziness much worse.

Serious skin reactions have been seen when SYMPAZAN is taken with other medicines and may require stopping its use. However, do not stop taking SYMPAZAN without first talking to your healthcare provider.  ­A serious skin reaction can happen at any time during treatment with SYMPAZAN. Call your healthcare provider immediately if you have skin blisters, rash, sores in mouth, hives, or any other allergic reaction. SYMPAZAN may also cause 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 or go to the emergency room if you have: a skin rash, fever or swollen glands that do not go away, swelling of your face, shortness of breath, dark urine, or yellowing of the skin or whites of the eyes.

Like other seizure medicines, SYMPAZAN 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 any of these symptoms:

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

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.

Do not take SYMPAZAN if you are allergic to clobazam or any of the ingredients in SYMPAZAN.

Before you take SYMPAZAN, tell your healthcare provider about all of your medical conditions, including if you:

• have liver or kidney problems
• have lung problems (respiratory disease)
• have or have had depression, mood problems, or suicidal thoughts or behavior
• use birth control medicine. SYMPAZAN may cause your birth control medicine to be less effective. Talk to your healthcare provider about the best birth control method to use.
• are pregnant or plan to become pregnant.
  • Taking SYMPAZAN late in pregnancy may cause your baby to have symptoms of sedation (breathing problems, sluggishness, low muscle tone) and/or withdrawal symptoms (jitteriness, irritability, restlessness, shaking, excessive crying, feeding problems).
  • Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with SYMPAZAN.
  • If you become pregnant while taking SYMPAZAN, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can register by calling 1-888-233-2334. For more information about the registry go to http://www.aedpregnancyregistry.org. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
• are breastfeeding or plan to breastfeed. SYMPAZAN can pass into breast milk.
  • Breastfeeding during treatment with SYMPAZAN may cause your baby to have sleepiness, feeding problems, and decreased weight gain.
  • Talk to your healthcare provider about the best way to feed your baby if you take SYMPAZAN.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking SYMPAZAN with certain other medicines can cause side effects or affect how well SYMPAZAN or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.

The most common side effects of SYMPAZAN are: sleepiness; pain with urination; slurred speech; drooling; fever; tiredness; constipation; acting aggressive; angry; or violent; problems with breathing; cough; and difficulty sleeping. These are not all the possible side effects of SYMPAZAN.

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

Please see full Prescribing Information, including Boxed Warning and Patient Information, at https://www.sympazan.com/pdfs/pi.pdf

References
1.SYMPAZAN [package insert]. Aquestive Therapeutics; 2024. 2. Integrated Clinical and Statistical Report. A pivotal, open-label, randomized, single-dose, four-period, four-arm, crossover, comparative bioavailability study of clobazam 20 mg and 10 mg oral films and ONFI® 20 mg and 10 mg tablets in healthy male and female volunteers under fasting conditions. August 2017. 3. Calories from carbohydrate content in SYMPAZAN, Nov 2019.