Onfi

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 has a risk for abuse and addiction, which can lead to overdose and death. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems (especially opioid medications such as codeine, hydrocodone) may cause very serious side effects, including death. To lower your risk, your doctor should have you take the smallest dose of clobazam that works, and take it for the shortest possible time. Be sure you know how to take clobazam and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.

Suddenly stopping this medication may cause serious (possibly fatal) withdrawal, especially if you have used it for a long time or in high doses. To prevent withdrawal, your doctor may lower your dose slowly. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as headaches, trouble sleeping, restlessness, hallucinations/confusion, depression, nausea, or seizures. Withdrawal symptoms may sometimes last weeks to months.

See also Warning section.

Drowsiness, dizziness, tiredness, headache, constipation, weight gain, 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 this medication has been prescribed because your doctor 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 (such as agitation, nervousness, confusion, memory loss), muscle weakness, loss of coordination, shaking (tremor) of the fingers, vision changes (such as blurred vision, double vision), trouble speaking, 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: fever, swollen lymph nodes, 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.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Do not share this medication with others. Sharing it is against the law.

Lab and/or medical tests (such as complete blood count, liver/kidney/thyroid function) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

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. Take your next dose at the regular time. Do not double the dose to catch up.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Before taking clobazam, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (such as 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: muscle disorders (such as myasthenia gravis, weakness, loss of coordination), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), liver disease, glaucoma, mental/mood disorders (such as depression, psychosis), breathing problems (such as asthma, chronic obstructive pulmonary disease-COPD, sleep apnea).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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.

Older adults may be more sensitive to the effects of the drug, especially drowsiness. This drug may also cause excitement instead of drowsiness in older adults.

Children may be more sensitive to the effects of the drug. 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. Newborn babies of mothers who use this medication late in pregnancy may have symptoms such as slow/shallow breathing, nonstop crying, shaking, or trouble feeding. 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, talk to your doctor right away about the risks and benefits of this medication. 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 may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: orlistat, sodium oxybate.

Other medications can affect the removal of clobazam from your body, which may affect how clobazam works. Examples include fluconazole, fluvoxamine, among others.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

See also Warning section.

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, read the Instructions for Use if available from your pharmacist before you start taking clobazam and each time you get a refill. Shake the medication 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. If your medication comes in an oral dosing syringe, use the syringe to measure the dose. 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.

The dosage is based on your medical condition and response to treatment. Infant's 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.

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 lasts or gets worse.