IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Clobazam - ORAL

COMMON BRAND NAME(S): Onfi

USES: This medication is used with other medications to help control seizures. It belongs to a class of medications called benzodiazepines, which act on the brain and nerves (central nervous system) to produce a calming effect. This drug works by enhancing the effects of a certain natural chemical in the body (GABA).

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking clobazam and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor. If unable to swallow tablets, they may be crushed and mixed with applesauce. If you are using the liquid form of this medication, shake the bottle well before each dose. Carefully measure the dose using a special measuring device/syringe. Do not use a household spoon because you may not get the correct dose. Read the Instructions for Use on how to properly use the special measuring device/syringe. If you have any questions, ask your pharmacist. If you are taking this medication once daily, then take it at bedtime. If you are taking this medication in divided doses, take the largest dose at bedtime. Dosage is based on your medical condition and response to treatment. In infants, the dosage may also be based on weight. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day. This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as headaches, trouble sleeping, restlessness, hallucinations/confusion, nausea, seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away. Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Do not increase your dose, take it more often, or use it for a longer time than prescribed. Properly stop the medication when so directed. When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well. Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: See also Warning section. Drowsiness, dizziness, tiredness, headache, constipation, weight gain, fever, cough, drooling, trouble sleeping, or nausea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: mental/mood/behavior changes (e.g., agitation, nervousness, confusion, memory loss), muscle weakness, loss of coordination, shaking (tremor) of the fingers, vision changes (e.g., blurred vision, double vision), slurred speech, decrease in sexual interest, painful urination. A small number of people who take anticonvulsants for any condition may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself. Get medical help right away if you have any very serious side effects, including: slow/shallow breathing. Clobazam may rarely cause very serious (possibly fatal) skin reactions, especially during the first 8 weeks of treatment or when restarting treatment with this medication. Get medical help right away if you develop any of the following symptoms: skin rash/blisters/peeling, itching, or mouth sores. If you have a very serious skin reaction and your doctor says it was caused by clobazam, you should not take the medication again. Ask your doctor or pharmacist for more details. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Before taking clobazam, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (e.g., diazepam); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: myasthenia gravis, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), kidney disease, liver disease, glaucoma, mental/mood disorders (e.g., depression, psychosis), brain disorders (e.g., head injury, brain damage), breathing problems (e.g., asthma, chronic obstructive pulmonary disease-COPD, sleep apnea), muscle disorders (e.g., weakness, loss of coordination). Before having surgery, tell your doctor or dentist that you are taking this medication. This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Alcohol may also increase the drug levels. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially drowsiness. This drug may also cause excitement instead of drowsiness in the elderly. Caution is advised when using this drug in children because they are more sensitive to the effects. This drug can often cause excitement in young children instead of drowsiness. During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor about the benefits and risks of using this medication during pregnancy. Since birth control pills, patches, implants, and injections may not work if taken with this medication (see also Drug Interactions section), discuss reliable forms of birth control with your doctor. This drug passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Severe Interactions These medications are not usually taken together. Consult your healthcare professional (e.g., doctor or pharmacist) for more in formation. SEDATIVE HYPNOTICS; ALCOHOL/SODIUM OXYBATE Serious Interactions These medications may interact and cause very harmful effects. Consult your healthcare professional (e.g., doctor or pharmacist) for more in formation. CLOBAZAM/STRONG; SELECTED MODERATE CYP2C19 INHIBITORS WEAK CYP2D6 INHIBITORS/ELIGLUSTAT BENZODIAZEPINES/OPIOIDS (COUGH AND COLD) CLOBAZAM/HORMONAL CONTRACEPTIVE AGENTS CYP2D6 INHIBITORS/TAMOXIFEN BENZODIAZEPINES/ETHYL ALCOHOL BENZODIAZEPINES/CLOZAPINE Moderate Interactions These medications may cause some risk when taken together. Consult your healthcare professional (e.g., doctor or pharmacist) for more in formation. CLOBAZAM/SELECTED MODERATE CYP2C19 INHIBITORS BENZODIAZEPINES/METHADONE FOR MAT BENZODIAZEPINES/OPIOIDS (IMMEDIATE RELEASE) BENZODIAZEPINES/OPIOIDS (EXTENDED RELEASE) SELECTED MODERATE-WEAK CYP3A4 INDUCERS/EXEMESTANE BENZODIAZEPINES/BUPRENORPHINE

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, slowed/reduced reflexes, slowed breathing, loss of consciousness.

NOTES: Do not share this medication with others. It is against the law. Laboratory and/or medical tests (such as liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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