What is the most important information I should know about clobazam tablets?
Clobazam tablets are 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:
Do not drive or operate heavy machinery until you know how taking clobazam tablets with opioids affects you.
- shallow or slowed breathing
- breathing stops (which may lead to the heart stopping)
- excessive sleepiness (sedation)
Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including clobazam tablets, 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 tablets. These serious side effects may also 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 tablets as prescribed by your healthcare provider.
Take clobazam tablets exactly as your healthcare provider prescribed.
- Do not share your clobazam tablets with other people.
- Keep clobazam tablets in a safe place and away from children.
Physical dependence and withdrawal reactions. Clobazam tablets can cause physical dependence and withdrawal reactions.
Do not suddenly stop taking clobazam tablets. Stopping clobazam tablets 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 tablets than prescribed or take clobazam tablets for longer than prescribed.
Clobazam tablets 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 tablets affects you.
- Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking clobazam tablets without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, clobazam tablets may make your sleepiness or dizziness much worse.
Serious skin reactions have been seen when clobazam tablets are taken with other medicines and may require stopping its use. Do not stop taking clobazam tablets without first talking to your healthcare provider.
- A serious skin reaction can happen at any time during your treatment with clobazam tablets, 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 the mouth, hives or any other allergic reaction.
Like other antiepileptic medicines, clobazam tablets 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 panic attacks
- new or worse depression
- feeling agitated or restless
- trouble sleeping (insomnia)
- new or worse anxiety or irritability
- acting aggressive, being angry or violent
- acting on dangerous impulses
- an extreme increase in activity and talking (mania)
- 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.
Before you take clobazam tablets, 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 tablets 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 tablets may harm your unborn baby.
- Tell your healthcare provider right away if you become pregnant while taking clobazam tablets. You and your healthcare provider will decide if you should take clobazam tablets while you are pregnant.
- Babies born to mothers receiving benzodiazepine medications (including clobazam tablets) 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 tablets, 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 tablets. You and your healthcare provider should decide if you will take clobazam tablets or breastfeed. 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 tablets with certain other medicines can cause side effects or affect how well clobazam tablets or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.
What are the ingredients in clobazam tablets?
Active Ingredient: clobazam
Inactive Ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch, silicon dioxide, and talc.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
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