Uses of Clobazam Oral Film:

• It is used to help control certain kinds of seizures.

What do I need to tell my doctor BEFORE I take Clobazam Oral Film?

• If you have an allergy to clobazam or any other part of clobazam oral film.
• If you are allergic to clobazam oral film; any part of clobazam oral film; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take clobazam oral film with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Clobazam Oral Film?

• Tell all of your health care providers that you take clobazam oral film. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may be habit-forming with long-term use.
• Do not change the dose or stop clobazam oral film. This could cause seizures. Talk with your doctor.
• Do not stop taking clobazam oral film all of a sudden without calling your doctor. You may have a greater risk of signs of withdrawal. If you need to stop clobazam oral film, you will want to slowly stop it as ordered by your doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how clobazam oral film affects you.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• If you are 65 or older, use clobazam oral film with care. You could have more side effects.
• Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also, like a condom, when taking clobazam oral film and for 1 month after the last dose.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking clobazam oral film, call your doctor right away.
• Taking clobazam oral film late in pregnancy may raise the chance of breathing or feeding problems, low body temperature, or withdrawal symptoms in the newborn. Talk with the doctor.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Clobazam Oral Film) best taken?

Use clobazam oral film as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Wash your hands before and after use.
• Be sure your hands are dry before you touch clobazam oral film.
• Place on the tongue and let dissolve.
• Do not take with liquid.
• When the film is dissolving, swallow saliva like normal. Do not chew, spit, or talk when the film is dissolving.
• If your dose is more than 1 film, take only 1 film at a time.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Shortness of breath.
• Fever.
• Feeling confused.
• Change in balance.
• Feeling very tired or weak.
• Slurred speech.
• If seizures are worse or not the same after starting clobazam oral film.
• Very bad dizziness or passing out.
• Feeling very sleepy.
• Patients who take clobazam oral film may be at a greater risk of having thoughts or actions of suicide. The risk may be greater in people who have had these thoughts or actions in the past. Call the doctor right away if signs like low mood (depression), nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of Clobazam Oral Film?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Dizziness.
• Drooling.
• Feeling tired or weak.
• Constipation.
• Throwing up.
• Feeling more or less hungry.
• Not able to sleep.
• Cough.
• Signs of a common cold.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Clobazam Oral Film?

• Store at room temperature.
• Store in foil pouch until ready for use.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time clobazam oral film is refilled. If you have any questions about clobazam oral film, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Frequently asked questions

• What is the difference between Sympazan and Onfi?