Sympazan is a benzodiazepine derivative and is supplied as an oral film containing 5 mg, 10 mg, or 20 mg of clobazam.

Sympazan is used in combination with other medications to treat seizures caused by Lennox-Gastaut syndrome in people 2 years of age or older. Lennox-Gastaut syndrome is a severe form of childhood epilepsy that also causes developmental and behavior problems.

It is not known if Sympazan is safe and effective in children less than 2 years old.

Sympazan can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing.

MISUSE OF SYMPAZAN CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Some people have thoughts about suicide while taking Sympazan. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Get emergency medical help if you have a severe skin reaction (skin pain, skin rash with blistering).

Do not stop using Sympazan without asking your doctor. You may have increased seizures or life-threatening withdrawal symptoms if you stop using the medicine suddenly after long-term use. Some withdrawal symptoms may last up to 12 months or longer.

Get medical help right away if you stop using Sympazan and have symptoms such as: unusual muscle movements, being more active or talkative, sudden and severe changes in mood or behavior, confusion, hallucinations, seizures, or thoughts about suicide.

Before taking this medicine

You should not take Sympazan if you are allergic to clobazam.

To make sure Sympazan is safe for you, tell your doctor if you have ever had:

• breathing problems or lung disease;

• depression, mood problems, or suicidal thoughts or behavior;

• a drug or alcohol addiction; or

• liver or kidney disease.

Some people have thoughts about suicide while taking seizure medicine. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

If you use Sympazan during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks.

Do not start or stop seizure medication during pregnancy without your doctor's advice. Clobazam may harm an unborn baby, but having a seizure during pregnancy could harm both mother and baby. Preventing seizures may outweigh these risks. Tell your doctor right away if you become pregnant.

There may be other seizure medications that are safer to use during pregnancy.

Sympazan can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. Use a back-up barrier birth control to prevent pregnancy: condom, diaphragm, cervical cap, or contraceptive sponge. Keep using birth control for at least 28 days after your last dose of Sympazan.

If you are breastfeeding, tell your doctor if you notice drowsiness or feeding problems in the nursing baby.

Sympazan is not approved for use by anyone younger than 2 years old.

Take Sympazan exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use Sympazan in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share Sympazan with another person, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it. Selling or giving away this medicine is against the law.

• For doses above 5 mg/day, take in two separate doses.

• Patients that weigh 30 kg or less, start at 5 mg daily, and increase as tolerated up to 20 mg daily.

• Patients who weigh greater than 30 kg, start at 10 mg daily, and increase as tolerated up to 40 mg daily.

You may take Sympazan with or without food. Do not take Sympazan with liquids.

Place the oral film on top of your tongue and allow it to dissolve.

Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.

Seizures may increase if you stop using Sympazan suddenly. Do not stop using Sympazan without asking your doctor. You may have life-threatening withdrawal symptoms if you stop using the medicine suddenly after long-term use.

Store at room temperature away from moisture and heat. Keep your medicine in a place where no one can use it improperly.

Throw away any unused oral suspension 90 days after you first opened the bottle.

Usual Adult Dose for Lennox-Gastaut Syndrome:

Initial total daily dose:
-Body weight 30 kg or less: 5 mg orally per day
-Body weight 30 over kg: 10 mg orally per day
Day 7 total daily dose:
-Body weight 30 kg or less: 10 mg orally per day
-Body weight over 30 kg: 20 mg orally per day
Day 14 total daily dose:
-Body weight 30 kg or less: 20 mg orally per day
-Body weight over 30 kg: 40 mg orally per day.

Usual Geriatric Dose for Lennox-Gastaut Syndrome:

Initial dose: 5 mg orally per day
Day 7 total daily dose:
-Body weight 30 kg or less: 5 mg orally per day
-Body weight over 30 kg: 10 mg orally per day
Day 14 total daily dose:
-Body weight 30 kg or less: 10 mg orally per day
-Body weight over 30 kg: 20 mg orally per day
Maximum dose:
-Body weight 30 kg or less: 20 mg/day
-Body weight over 30 kg: 40 mg/day.

Usual Pediatric Dose for Lennox-Gastaut Syndrome:

2 years or older:
Initial daily dose:
-Body weight 30 kg or less: 5 mg orally per day
-Body weight over 30 kg: 10 mg orally per day
Day 7 total daily dose:
-Body weight 30 kg or less: 10 mg orally per day
-Body weight over 30 kg: 20 mg orally per day
Day 14 total daily dose:
-Body weight 30 kg or less: 20 mg orally per day
-Body weight over 30 kg: 40 mg orally per day

Comments:
-Daily dose greater than 5 mg should be administered in divided doses 2 times a day.
-Doses should be escalated no more rapidly than weekly.
-Doses should be withdrawn gradually by tapering the total daily dose by 5 to 10 mg on a weekly basis until discontinued.

Use: Adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome:

You should not take Sympazan if you are allergic to clobazam.

To make sure Sympazan is safe for you, tell your doctor if you have ever had:

• breathing problems or lung disease;

• depression, mood problems, or suicidal thoughts or behavior;

• a drug or alcohol addiction; or

• liver or kidney disease.

Some people have thoughts about suicide while taking seizure medicine. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

If you use Sympazan during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks.

Do not start or stop seizure medication during pregnancy without your doctor's advice. Clobazam may harm an unborn baby, but having a seizure during pregnancy could harm both mother and baby. Preventing seizures may outweigh these risks. Tell your doctor right away if you become pregnant.

There may be other seizure medications that are safer to use during pregnancy.

Sympazan can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. Use a back-up barrier birth control to prevent pregnancy: condom, diaphragm, cervical cap, or contraceptive sponge. Keep using birth control for at least 28 days after your last dose of Sympazan.

If you are breastfeeding, tell your doctor if you notice drowsiness or feeding problems in the nursing baby.

Sympazan is not approved for use by anyone younger than 2 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of clobazam can be fatal if you take it with alcohol, opioid medicine, or other drugs that cause drowsiness or slow your breathing.

Overdose symptoms may include extreme drowsiness or weakness, confusion, slow breathing, or loss of consciousness.

Avoid drinking alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how Sympazan will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction to Sympazan (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Sympazan can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• weak or shallow breathing;

• severe drowsiness, feeling like you might pass out; or

• problems with balance or muscle movement.

Drowsiness or dizziness may last longer in older adults. Use caution to avoid falling or accidental injury.

Common Sympazan side effects may include:

• drowsiness, tiredness, trouble sleeping;

• slurred speech;

• anger, aggression;

• constipation;

• painful urination;

• fever, cough, breathing problems; or

• drooling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Taking Sympazan with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may interact with clobazam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.