Medication Guide

Clonazepam ODT (Kloe-NA-za-pam) Orally Disintegrating Tablets, USP (ODT) CIV

What is the most important information I should know about Clonazepam ODT?

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CLONAZEPAM ODT is 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:

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shallow or slowed breathing

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breathing stops (which may lead to the heart stopping)

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excessive sleepiness (sedation)

 

Do not drive or operate heavy machinery until you know how taking CLONAZEPAM ODT with opioids affects you.

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Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including CLONAZEPAM ODT, which can lead to overdose and serious side effects including coma and death.

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Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including CLONAZEPAM ODT. 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.

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You can develop an addiction even if you take CLONAZEPAM ODT exactly as prescribed by your healthcare provider.

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Take CLONAZEPAM ODT exactly as your healthcare provider prescribed.

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Do not share your CLONAZEPAM ODT with other people.

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Keep CLONAZEPAM ODT in a safe place and away from children.

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Physical dependence and withdrawal reactions. CLONAZEPAM ODT can cause physical dependence and withdrawal reactions, especially if you continue to take CLONAZEPAM ODT for several days to several weeks.

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Do not suddenly stop taking CLONAZEPAM ODT. Stopping CLONAZEPAM ODT 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.

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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.

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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.

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Do not take more CLONAZEPAM ODT than prescribed or take CLONAZEPAM ODT for longer than prescribed.

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CLONAZEPAM ODT can make you sleepy or dizzy and can slow your thinking and motor skills. This may get better over time.

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Do not drive, operate heavy machinery, or do other dangerous activities until you know how CLONAZEPAM ODT affects you.

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CLONAZEPAM ODT may cause problems with your coordination, especially when you are walking or picking things up.

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Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking CLONAZEPAM ODT until you talk to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, CLONAZEPAM ODT may make your sleepiness or dizziness worse.

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Like other antiepileptic medicines, CLONAZEPAM ODT may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

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thoughts about suicide or dying

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attempts to commit suicide

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new or worse depression

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new or worse anxiety

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feeling agitated or restless

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panic attacks

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trouble sleeping (insomnia)

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new or worse irritability

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acting aggressive, being angry, or violent

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acting on dangerous impulses

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an extreme increase in activity and talking(mania)

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other unusual changes in behavior or mood

 

How can I watch for early symptoms of suicidal thoughts and actions?

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Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.

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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. 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.

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Do not stop CLONAZEPAM ODT without first talking to a healthcare provider.

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Stopping CLONAZEPAM ODT suddenly can cause serious problems. Stopping CLONAZEPAM ODT suddenly can cause seizures that will not stop (status epilepticus).

What is CLONAZEPAM ODT?

CLONAZEPAM ODT is a prescription medicine used alone or with other medicines to treat:

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certain types of seizure disorders (epilepsy) in adults and children

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panic disorder with or without fear of open spaces (agoraphobia) in adults

CLONAZEPAM ODT is a federally controlled substance (C-IV) because if contains clonazepam that can be abused or lead to dependence. Keep CLONAZEPAM ODT in a safe place to prevent misuse and abuse. Selling or giving away CLONAZEPAM ODT may harm others, and is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

It is not known if CLONAZEPAM ODT is safe or effective in treating panic disorder in children younger than 18 years old.

Do not take CLONAZEPAM ODT if you:

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are allergic to benzodiazepines

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have significant liver disease

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have an eye disease called acute narrow angle glaucoma

Ask your healthcare provider if you are not sure if you have any of the problems listed above.

Before you take CLONAZEPAM ODT, tell your healthcare provider about all your medical conditions, including if you

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have liver or kidney problems

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have lung problems (respiratory disease)

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have or have had depression, mood problems, or suicidal thoughts or behavior

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are pregnant or plan to become pregnant.

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Taking CLONAZEPAM ODT late in pregnancy may cause your baby to have symptoms of sedation (breathing problems, sluggishness, low muscle tone), and/or withdrawal symptoms (jitteriness, irritability, restlessness, shaking, excessive crying, feeding problems).

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Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with CLONAZEPAM ODT.

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If you become pregnant while taking CLONAZEPAM ODT, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can register by calling 1-888-233- 2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.

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are breastfeeding or plan to breastfeed. Clonazepam can pass into your breast milk.

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Breastfeeding during treatment with CLONAZEPAM ODT may cause your baby to have sleepiness, feeding problems, and decreased weight gain.

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Talk to your healthcare provider about the best way to feed your baby while you take CLONAZEPAM ODT.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking CLONAZEPAM ODT with certain other medicines can cause side effects or affect how well CLONAZEPAM ODT or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.

How should I take CLONAZEPAM ODT?

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Take CLONAZEPAM ODT exactly as your healthcare provider tells you. CLONAZEPAM is available as a tablet or as an orally disintegrating tablet.

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Do not stop taking CLONAZEPAM ODT without first talking to your healthcare provider. Stopping CLONAZEPAM ODT suddenly can cause serious problems.

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CLONAZEPAM ODT can be taken with or without water.

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After opening the bottle, with dry hands, take the orally disintegrating tablet and place it in your mouth.

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The orally disintegrating tablet will melt quickly.

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If you take too much CLONAZEPAM ODT, call your healthcare provider or local Poison Control Center right away.

What should I avoid while taking CLONAZEPAM ODT?

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CLONAZEPAM ODT can slow your thinking and motor skills. Do not drive, operate heavy machinery, or do other dangerous activities until you know how CLONAZEPAM ODT affects you.

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Do not drink alcohol or take other medicines that may make you sleepy or dizzy while taking CLONAZEPAM ODT until you talk to your healthcare provider. When taken with alcohol or medicines that cause sleepiness or dizziness, CLONAZEPAM ODT may make your sleepiness or dizziness much worse.

What are the possible side effects of CLONAZEPAM ODT?

See “What is the most important information I should know about CLONAZEPAM ODT?”

CLONAZEPAM ODT can also make your seizures happen more often or make them worse. Call your healthcare provider right away if your seizures get worse while taking CLONAZEPAM ODT.

The most common side effects of CLONAZEPAM ODT include:

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Drowsiness

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Dizziness

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Fatigue

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problems with walking and coordination

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depression

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problems with memory

These are not all the possible side effects of CLONAZEPAM ODT. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Sun Pharmaceutical Industries, Inc. at 1-800-818-4555.

How should I store CLONAZEPAM ODT?

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Store clonazepam orally disintegrating tablets at 20° to 25°C (68° to 77°F); excursions permitted 15°to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture.

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Keep CLONAZEPAM ODT and all medicines out of the reach of children.

General information about the safe and effective use of CLONAZEPAM ODT. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CLONAZEPAM ODT for a condition for which it was not prescribed. Do not give CLONAZEPAM ODT to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about CLONAZEPAM ODT that is written for health professionals.

What are the ingredients in CLONAZEPAM ODT?

Active ingredient: clonazepam USP

Inactive ingredients: mannitol, crospovidone, pregelatinized maize starch, aspartame, talc, and magnesium stearate.

Distributed by:

Sun Pharmaceutical Industries Inc.

Cranbury, NJ 08512

For more information, go to www.sunpharma.com or call 1-800-818-4555. This Medication Guide has been approved by the U.S. Food and Drug Administration.

Rev. 08/2022