ONFI contains the active ingredient clobazam, which is in tablet form with available strengths of 10 mg and 20 mg. It includes inactive ingredients like corn starch, lactose monohydrate, and magnesium stearate. Clobazam is a benzodiazepine class medication but the specific use is not mentioned in this section.

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label. Shake well before using. Use a specially marked oral syringe, spoon, or dropper to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions. Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 2 years for selected conditions, precautions do apply. People 65 years and older may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets. Store it out of sight in a safe place. Do not share it with others. Misuse of this medication is dangerous and against the law. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container. Get rid of any unused medication 90 days after opening the bottle or after the medication expires, whichever is first. This medication may cause harm and death if it is taken by other adults, children, or pets. It is important to get rid of the medication as soon as you no longer need it, or it is expired. To get rid of this medication: -Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location. -Follow the steps given to you by your pharmacy. You may be given a pre-paid mail-back envelope or disposal product to safely get rid of your medication. -If other options are not available, check the package insert or medication guide to see if it should be flushed down the toilet or put in your trash at home. If you are not sure, ask your care team. If it is safe to put it in your trash, empty the medication out of the container. Mix it with cat litter, dirt, used coffee grounds, or another unwanted substance. Seal the mixture in a container, such as a plastic bag. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake -Rash, fever, and swollen lymph nodes -Redness, blistering, peeling, or loosening of the skin, including inside the mouth -Thoughts of suicide or self-harm, worsening mood, feelings of depression Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome): -Constipation -Dizziness -Drowsiness -Excessive drooling -Fever -Unusual weakness or fatigue

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -CYP2C19 poor metabolizer, which means your body breaks down certain medications slowly -Glaucoma -Kidney disease -Liver disease -Lung or breathing disease, such as asthma or COPD -Mental health conditions -Substance use disorder -Suicidal thoughts, plans, or attempt by you or a family member -An unusual or allergic reaction to clobazam, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following: -Sodium oxybate -Thioridazine This medication may interact with the following: -Alcohol -Cannabidiol -Estrogen and progestin hormones -Medications that cause drowsiness before a procedure, such as propofol -Medications that help you fall asleep -Medications that relax muscles -Opioids for pain or cough -Other benzodiazepines -Phenothiazines, such as chlorpromazine or prochlorperazine -Some antihistamines -Some medications for depression, such as amitriptyline or trazodone -Some medications for seizures, such as phenobarbital or primidone -Valerian This medication may affect how other medications work, and other medications may affect the way this medication works. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. There is a risk of abuse, misuse, and addiction with this medication. It is important to take this medication as directed by your care team. This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects. This medication is a CNS depressant. This is a type of medication or substance that slows down your brain and nervous system. Taking it with other CNS depressants can make you too sleepy. This can make it hard to breathe and stay awake. In some cases, it can cause coma and death. CNS depressants include opioids, benzodiazepines, muscle relaxants, medications for sleep, alcohol, and street drugs. Talk to your care team about all the medications, vitamins, and supplements you take. They can tell you what is safe to take together. Call emergency services right away if you have slow or shallow breathing, feel dizzy or confused, or have trouble staying awake. Do not stop taking this medication or reduce your dose without first talking to your care team. If you have taken this medication for a long time or take a high dose, your body may rely on it. Stopping it suddenly may cause a severe reaction. Talk to your care team about how long you need to take this medication. When it is time to stop, the dose will be slowly lowered over time to reduce the risk of side effects. This medication may worsen depression and cause thoughts of suicide. This can happen at any time but is more common after first starting treatment and after a change in dose. Talk to your care team right away if you have changes in mood and behavior or thoughts of self-harm or suicide. They can help you. This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Talk to your care team right away if you have fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or you might notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms. Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the medications and doses you take on the card. Talk to your care team if you may be pregnant. Prolonged use of this medication during pregnancy can cause withdrawal in a newborn. Estrogen and progestin hormones may not work as well while you are taking this medication and for 28 days after the last dose. Your care team can help you find the contraceptive option that works for you. Talk to your care team before breastfeeding. Changes to your treatment plan may be needed. If you breastfeed while taking this medication, seek medical care right away if you notice the child has slow or noisy breathing, is unusually sleepy or not able to wake up, or is limp.

What are the most serious risks of this medication?

Do not stop taking this medication or reduce your dose without first talking to your care team. If you have taken this medication for a long time or take a high dose, your body may rely on it. Taking the medication away too quickly can cause symptoms, such as anxiety, tremors, and trouble sleeping. In severe cases, hallucinations and seizures can occur. Talk to your care team about how long you need to take this medication. When it is time to stop, the dose will be slowly lowered over time to reduce the risk of side effects.