MEDICATION GUIDEClobazam (KLOE-ba-zam) Tablets,CIV

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

• Clobazam 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 clobazam with opioids affects you.

• Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including clobazam, 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 clobazam. These serious side effects may include delirium, 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 clobazam as prescribed by your healthcare provider.
  • Take clobazam exactly as your healthcare provider prescribed.
  • Do not share your clobazam with other people.
  • Keep clobazam in a safe place and away from children.
• Physical dependence and withdrawal reactions. Clobazam can cause physical dependence and withdrawal reactions.
  • Do not suddenly stop taking clobazam. Stopping clobazam 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 between physical dependence and drug addiction.
  • Do not take more clobazam than prescribed or take clobazam for longer than prescribed.

• Clobazam 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 clobazam affects you.
• Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking clobazam without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, clobazam may make your sleepiness or dizziness much worse.

• Serious skin reactions have been seen when clobazam is taken with other medicines and may require stopping its use. Do not stop taking clobazam without first talking to your healthcare provider.
  • A serious skin reaction can happen at any time during your treatment with clobazam, 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 medicines, clobazam 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
• 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)
• new or worse panic attacks
• acting aggressive, being angry or violent
• acting on dangerous impulses
• other unusual changes in behavior or mood

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.

Stopping a seizure medicine suddenly in a patient who has epilepsy 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.

What is clobazam?

• Clobazam 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.
• Clobazam is a federally controlled substance (C-IV) because it contains clobazam that can be abused or lead to dependence. Keep clobazam in a safe place to prevent misuse and abuse. Selling or giving away clobazam 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.

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

Do not take clobazam if you:

• are allergic to clobazam or any of the ingredients in clobazam.  See the end of this Medication Guide for a complete list of ingredients in clobazam tablets.

Before you take clobazam, tell your healthcare provider about all 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. Clobazam 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. Clobazam may harm your unborn baby.
  • Tell your healthcare provider right away if you become pregnant while taking clobazam. You and your healthcare provider will decide if you should take clobazam while you are pregnant.
  • Babies born to mothers receiving benzodiazepine medications (including clobazam) 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 clobazam, 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.
• Clobazam can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take clobazam. You and your healthcare provider should decide if you will take clobazam or breast feed. You should not do both.

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

How should I take clobazam?

• Take clobazam exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how much clobazam to take and when to take it.
• Clobazam tablets can be taken whole, broken in half along the score, or crushed and mixed in applesauce.
• Clobazam tablets can be taken with or without food.
• Your healthcare provider may change your dose if needed. Do not change your dose of clobazam without talking to your healthcare provider.
• Do not stop taking clobazam without first talking to your healthcare provider.
• Stopping clobazam suddenly can cause serious problems.
• If you take too much clobazam, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking clobazam?

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

What are the possible side effects of clobazam?

Clobazam may cause serious side effects, including: See "What is the most important information I should know about clobazam?"

The most common side effects of clobazam include:

• sleepiness
• drooling
• constipation
• cough
• pain with urination
• fever
• acting aggressive, being angry, or violent
• difficulty sleeping
• slurred speech
• tiredness
• problems with breathing

These are not all the possible side effects of clobazam. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store clobazam?

• Store clobazam tablets at room temperature between 68°F to 77°F (20°C to 25°C).

Tablets

• Keep clobazam tablets in a dry place.

General Information about the safe and effective use of clobazam.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use clobazam for a condition for which it was not prescribed. Do not give clobazam to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about clobazam that is written for health professionals.

What are the ingredients in clobazam?

Tablets

Active ingredient: clobazam
Inactive ingredients: lactose monohydrate, pregelatinized starch, colloidal silicon dioxide, talc, and magnesium stearate.

Distributed by: Celltrion USA, Inc.
One Evertrust Plaza Suite 1207, Jersey City, New Jersey, 07302, USA

For more information about Clobazam, call Celltrion at 1-844-837-6511.

This Medication Guide has been approved by the U.S. Food and Drug Administration                                                                                                                           Revised: 02/2021