Sympazan is a prescription medication used along with other medications to treat seizures caused by Lennox-Gastaut Syndrome.

Sympazan belongs to a group of drugs called benzodiazepines. It works by decreasing abnormal electrical activity in the brain.

This medication comes in an oral film. Do not chew, spit, or talk while the film dissolves. Do not take with liquids. 

Common side effects include fever, drooling, constipation and upper respiratory tract infection. Sympazan can make you sleepy or dizzy. Do not drive or operate heavy machinery until you know how Sympazan affects you.

Sympazan 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.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Sympazan. See the “Sympazan Precautions” section.

Common side effects of Sympazan include the following:

• Drowsiness / sleepiness
• Feeling calm
• Fever
• Upper respiratory tract infection (infection of the nose, throat, and airways)
• Tiredness
• Drooling
• Aggressive behavior
• Irritability
• Vomiting

This is not a complete list of Sympazan side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Opioid pain relieving medications including

  • tramadol (Ultram), morphine (MS Contin), hydromorphone (Dilaudid), oxymorphone (Opana), oxycodone (Oxycontin), hydrocodone (Vantrela), fentanyl (Duragesic), codeine, meperidine (Demerol)

• Alcohol and other sedating medications such as:

  • barbiturate medications including butalbital, pentobarbital (Nembutal), phenobarbital (Luminal)

  • benzodiazepine medications including clonazepam (Klonopin), diazepam (Diastat), lorazepam (Ativan), midazolam (Versed), alprazolam (Xanax), temazepam (Restoril)

  • hypnotic medications including eszopiclone (Lunesta), zeleplon (Sonata), zolpidem (Ambien)

  • first generation antihistamine medications including diphenhydramine (Benedryl), doxylamine (Diclectin), promethazine (Phenergan), hydroxyzine (Vistaril), chlorpheniramine (Chlor-Trimeton)

  • muscle relaxant medications including baclofen (Lioresal), carisoprodol (Somadril), cyclobenzaprine (Flexeril), methocarbamol (Robaxin), tizanidine (Zanaflex), gabapentin (Neurontin), pregabalin (Lyrica)

  • opioid pain relieving medications including tramadol (Ultram), morphine (MS Contin), hydromorphone (Dilaudid), oxymorphone (Opana), oxycodone (Oxycontin), hydrocodone (Vantrela), fentanyl (Duragesic), codeine, meperidine (Demerol)

  • antidepressant medications including amitriptyline (Elavil), trazodone (Oleptro), mirtazapine (Remeron), doxepin (Sinequan), nortriptyline (Pamelor), nefazodone (Serzone)

  • antipsychotic medications including olanzepine (Zyprexa), clozapine (Clozaril), haloperidol (Haldol), fluphenazine (Prolixin), quetiapine (Seroquel), prochlorperazine (Compazine)

• Certain birth control pills

• Medications that use the enzyme CYP2D6 such as desipramine, dextromethorphan, atomoxetine

• Medications that strongly inhibit the enzyme CYP2C19 such as fluconazole, fluvoxamine, ticlopidine, and others.

This is not a complete list of Sympazan drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Sympazan including the following:

• Do not stop taking Sympazan without first talking to your healthcare provider. Stopping Sympazan suddenly can cause serious side effects.

• Sympazan is a benzodiazepine medicine. Benzodiazepines can cause severe drowsiness, breathing problems (respiratory depression), coma, and death when taken with opioid medicines.

• Sympazan can make you sleepy or dizzy and can slow your thinking and motor skills. This may get better over time. Do not drive, operate heavy machinery, or do other dangerous activities until you know how Sympazan affects you. Sympazan may cause problems with your coordination, especially when you are walking or picking things up.

• Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking Sympazan until you talk to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, Sympazan may make your sleepiness or dizziness much worse.

• Sympazan can cause withdrawal symptoms. Do not stop taking Sympazan all of a sudden without first talking to a healthcare provider. Stopping Sympazan suddenly can cause seizures that will not stop (status epilepticus), hearing or seeing things that are not there (hallucinations), shaking, nervousness, and stomach and muscle cramps. o Talk to your healthcare provider about slowly stopping Sympazan to avoid withdrawal symptoms.

• Sympazan can be abused and cause dependence. Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.

• Sympazan is a federally controlled substance (CIV) because it can be abused or lead to dependence. Keep Sympazan in a safe place to prevent misuse and abuse. Selling or giving away Sympazan may harm others, and is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

• Serious skin reactions have been seen when Sympazan is taken with other medicines and may require stopping its use. Do not stop taking Sympazan without first talking to your healthcare provider. A serious skin reaction can happen at any time during your treatment with Sympazan, but is more likely to happen within the first 8 weeks of treatment. These skin reactions may need to be treated right away. Call your healthcare provider immediately if you have skin blisters, rash, sores in mouth, hives or any other allergic reaction.

• Like other antiepileptic drugs, 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, especially if they are new, worse, or worry you:

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

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. 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.

Do not take Sympazan if you are allergic to Sympazan or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Sympazan, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Sympazan, tell your doctor about all of your medical conditions. Especially tell your doctor 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. Sympazan may harm your unborn baby.
  • Tell your healthcare provider right away if you become pregnant while taking Sympazan. You and your healthcare provider will decide if you should take Sympazan while you are pregnant.
  • Babies born to mothers receiving benzodiazepine medications (including Sympazan) late in pregnancy may be at some risk of experiencing breathing problems, feeding problems, dangerously low body temperature, and withdrawal symptoms.
  • 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.
• Sympazan can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Sympazan. You and your healthcare provider should decide if you will take Sympazan or breast feed. You should not do both.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. Sympazan may harm your unborn baby.

Tell your healthcare provider right away if you become pregnant while taking Sympazan. You and your healthcare provider will decide if you should take Sympazan while you are pregnant.

Babies born to mothers receiving benzodiazepine medications (including Sympazan) late in pregnancy may be at some risk of experiencing breathing problems, feeding problems, dangerously low body temperature, and withdrawal symptoms.

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.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Sympazan can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Sympazan. You and your healthcare provider should decide if you will take Sympazan or breast feed. You should not do both.

• Take Sympazan exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how much Sympazan to take and when to take it.
• Place the entire Sympazan oral film on top of the tongue.
• Sympazan oral films can be taken with or without food.
• Do not take liquids with Sympazan oral films.
• Take only 1 Sympazan oral film at a time.
• Read the Instructions for Use at the end of this Medication Guide for information on the right way to take Sympazan oral films.
• Your healthcare provider may change your dose if needed. Do not change your dose of Sympazan without talking to your healthcare provider.
• Do not stop taking Sympazan without first talking to your healthcare provider.
• Stopping Sympazan suddenly can cause serious problems.
• If you take too much Sympazan, call your healthcare provider or go to the nearest hospital emergency room right away.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• The condition being treated
• Other medical conditions you have
• Other medications you are taking
• How you respond to this medication
• Your weight
• Your age

The recommended dose range of Sympazan (clobazam) for the treatment of seizures caused by Lennox-Gastaut Syndrome (LGS) is 5 mg to 40 mg.

If you take too much Sympazan, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Sympazan oral film between 68°F to 77°F (20°C to 25°C).

• Keep this and all medicines out of the reach of children.

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

• Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate

• Limit dosages and durations to the minimum required

• Follow patients for signs and symptoms of respiratory depression and sedation