Clonazepam Tablet
FDA Label NDC 80425-0358

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Of Tennessee, Llc for the product Clonazepam (NDC 80425-0358). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding warning: risks from concomitant use with opioids; abuse, misuse, and addiction; and dependence and withdrawal reactions, description, pharmacodynamics:, pharmacokinetics:, seizure disorders:, panic disorder:, contraindications, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Warning: Risks From Concomitant Use With Opioids; Abuse, Misuse, And Addiction; And Dependence And Withdrawal Reactions

→ Description

→ Pharmacodynamics:

→ Pharmacokinetics:

→ Seizure Disorders:

→ Panic Disorder:

→ Contraindications

→ Warnings

→ Suicidal Behavior And Ideation:

→ Adverse Reactions

→ Other

→ Dosage And Administration

→ How Supplied

→ Spl Medguide

→ Principal Display Panel - 0.5 Mg

Warning: Risks From Concomitant Use With Opioids; Abuse, Misuse, And Addiction; And Dependence And Withdrawal Reactions

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation (see WARNINGSand PRECAUTIONS).
The use of benzodiazepines, including clonazepam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing clonazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS).
The continued use of benzodiazepines, including clonazepam, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of clonazepam after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue clonazepam or reduce the dosage (see DOSAGE AND ADMINISTRATIONand WARNINGS).

Description

Clonazepam, a benzodiazepine, is available as scored tablets debossed with “1” and “2” containing 0.5 mg of clonazepam and unscored tablets debossed with “C 1” on 1 mg tablets and “C 2” on 2 mg tablets containing 1 mg or 2 mg of clonazepam. Each tablet contains anhydrous lactose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and starch (corn), with the following colorants: 0.5 mg-FD&C Yellow No. 6 Lake and 1 mg- FD&C Blue No.2 Lake.

Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2 H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula:

Clonazepam Structural Formula (Fig 1)

Pharmacodynamics:

The precise mechanism by which clonazepam exerts its antiseizure and antipanic effects is unknown, although it is believed to be related to its ability to enhance the activity of gamma aminobutyric acid (GABA), the major inhibitory neurotransmitter in the central nervous system.

Pharmacokinetics:

Clonazepam is rapidly and completely absorbed after oral administration. The absolute bioavailability of clonazepam is about 90%. Maximum plasma concentrations of clonazepam are reached within 1 to 4 hours after oral administration. Clonazepam is approximately 85% bound to plasma proteins. Clonazepam is highly metabolized, with less than 2% unchanged clonazepam being excreted in the urine. Biotransformation occurs mainly by reduction of the 7-nitro group to the 4-amino derivative. This derivative can be acetylated, hydroxylated and glucuronidated. Cytochrome P-450 including CYP3A, may play an important role in clonazepam reduction and oxidation. The elimination half-life of clonazepam is typically 30 to 40 hours. Clonazepam pharmacokinetics are dose-independent throughout the dosing range. There is no evidence that clonazepam induces its own metabolism or that of other drugs in humans.

Seizure Disorders:

Clonazepam is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam may be useful.

Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect).

Panic Disorder:

Clonazepam is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.

The efficacy of clonazepam was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see CLINICAL PHARMACOLOGY:Clinical Trials).

Panic disorder (DSM-V) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.

The effectiveness of clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

Contraindications

Clonazepam is contraindicated in patients with the following conditions:

History of sensitivity to benzodiazepines
Clinical or biochemical evidence of significant liver disease
Acute narrow angle glaucoma (it may be used in patients with open angle glaucoma who are receiving appropriate therapy).

Warnings

Risks from Concomitant Use with Opioids:Concomitant use of benzodiazepines, including clonazepam, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of benzodiazepines and opioids for patients for whom alternative treatment options are inadequate.

Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe clonazepam concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. Advise both patients and caregivers about the risks of respiratory depression and sedation when clonazepam is used with opioids (see PRECAUTIONS: Information for Patientsand PRECAUTIONS: Drug Interactions).

Abuse, Misuse, and Addiction:The use of benzodiazepines, including clonazepam, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death (see DRUG ABUSE AND DEPENDENCE: Abuse).

Before prescribing clonazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (e.g., using a standardized screening tool). Use of clonazepam, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of clonazepam along with monitoring for signs and symptoms of abuse, misuse, and addiction. Prescribe the lowest effective dosage; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate.

Dependence and Withdrawal Reactions:To reduce the risk of withdrawal reactions, use a gradual taper to discontinue clonazepam or reduce the dosage (a patient-specific plan should be used to taper the dose) (see DOSAGE AND ADMINISTRATION:Discontinuation or Dosage Reduction of clonazepam).

Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use.

Acute Withdrawal ReactionsThe continued use of benzodiazepines, including clonazepam, may lead to clinically significant physical dependence. Abrupt discontinuation or rapid dosage reduction of clonazepam after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) (see DRUG ABUSE AND DEPENDENCE: Dependence).

Protracted Withdrawal SyndromeIn some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months (see DRUG ABUSE AND DEPENDENCE: Dependence).

Interference with Cognitive and Motor Performance:Since clonazepam produces CNS depression, patients receiving this drug should be cautioned against engaging in hazardous occupations requiring mental alertness, such as operating machinery or driving a motor vehicle. They should also be warned about the concomitant use of alcohol or other CNS-depressant drugs during clonazepam therapy (see PRECAUTIONS: Drug Interactionsand PRECAUTIONS: Information for Patients).

Suicidal Behavior And Ideation:

Antiepileptic drugs (AEDs), including clonazepam, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43% compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.

The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.

The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed.

Table 1 shows absolute and relative risk by indication for all evaluated AEDs.

Table 1 Risk by Indication for Antiepileptic Drugs in the Pooled Analysis
Indication	Placebo Patients with Events Per 1000 Patients	Drug Patients with Events Per 1000 Patients	Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients	Risk Difference: Additional Drug Patients with Events per 1000 Patients
Epilepsy	1.0	3.4	3.5	2.4
Psychiatric	5.7	8.5	1.5	2.9
Other	1.0	1.8	1.9	0.9
Total	2.4	4.3	1.8	1.9

The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.

Anyone considering prescribing clonazepam or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and with an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Neonatal Sedation and Withdrawal Syndrome:Use of clonazepam late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate (see PRECAUTIONS: Pregnancy). Monitor neonates exposed to clonazepam during pregnancy or labor for signs of sedation and monitor neonates exposed to clonazepam during pregnancy for signs of withdrawal; manage these neonates accordingly.

Adverse Reactions

The adverse experiences for clonazepam are provided separately for patients with seizure disorders and with panic disorder.

Other

Adverse Events Occurring at an Incidence of 1% or More among Clonazepam-Treated Patients:

Table 3 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred during acute therapy of panic disorder from a pool of two 6- to 9-week trials. Events reported in 1% or more of patients treated with clonazepam (doses ranging from 0.5 to 4 mg/day) and for which the incidence was greater than that in placebo-treated patients are included.

The prescriber should be aware that the figures in Table 3 cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence in the population studied.

Table 3. Treatment-Emergent Adverse Event Incidence in 6- to 9- Week Placebo-Controlled Clinical Trials
Events reported by at least 1% of patients treated with clonazepam and for which the incidence was greater than that for placebo.
Clonazepam Maximum Daily Dose
Adverse Event by Body System	< 1 mg n = 96 %	1- < 2 mg n = 129 %	2- < 3 mg n = 113 %	≥ 3 mg n = 235 %	All Clonazepam Groups N = 574 %	Placebo N = 294 %
Central & Peripheral Nervous System
Somnolence Indicates that the p-value for the dose-trend test (Cochran-Mantel-Haenszel) for adverse event incidence was ≤ 0.10.	26	35	50	36	37	10
Dizziness	5	5	12	8	8	4
Coordination Abnormal ^†	1	2	7	9	6	0
Ataxia ^†	2	1	8	8	5	0
Dysarthria ^†	0	0	4	3	2	0
Psychiatric
Depression	7	6	8	8	7	1
Memory Disturbance	2	5	2	5	4	2
Nervousness	1	4	3	4	3	2
Intellectual Ability Reduced	0	2	4	3	2	0
Emotional Lability	0	1	2	2	1	1
Libido Decreased	0	1	3	1	1	0
Confusion	0	2	2	1	1	0
Respiratory System
Upper Respiratory Tract Infection ^†	10	10	7	6	8	4
Sinusitis	4	2	8	4	4	3
Rhinitis	3	2	4	2	2	1
Coughing	2	2	4	0	2	0
Pharyngitis	1	1	3	2	2	1
Bronchitis	1	0	2	2	1	1
Gastrointestinal System
Constipation ^†	0	1	5	3	2	2
Appetite Decreased	1	1	0	3	1	1
Abdominal Pain ^†	2	2	2	0	1	1
Body as a Whole
Fatigue	9	6	7	7	7	4
Allergic Reaction	3	1	4	2	2	1
Musculoskeletal
Myalgia	2	1	4	0	1	1
Resistance Mechanism Disorders
Influenza	3	2	5	5	4	3
Urinary System
Micturition Frequency	1	2	2	1	1	0
Urinary Tract Infection ^†	0	0	2	2	1	0
Vision Disorders
Blurred Vision	1	2	3	0	1	1
Reproductive Disorders Denominators for events in gender-specific systems are: n = 240 (clonazepam), 102 (placebo) for male, and 334 (clonazepam), 192 (placebo) for female.
Female
Dysmenorrhea	0	6	5	2	3	2
Colpitis	4	0	2	1	1	1
Male
Ejaculation Delayed	0	0	2	2	1	0
Impotence	3	0	2	1	1	0

Dosage And Administration

Clonazepam is available as a tablet. The tablets should be administered with water by swallowing the tablet whole.

How Supplied

Clonazepam tablets USP 0.5 mg are orange, round, flat faced, beveled edge, scored, debossed with “1” and “2” on one side and plain on other. They are supplied as follows:

Bottles of 30 NDC: 80425-0358-01

Bottles of 60 NDC: 80425-0358-02

Bottles of 90 NDC: 80425-0358-03

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].

Manufactured For:
Accord Healthcare, Inc.,
1009 Slater Road,
Suite 210-B,
Durham, NC 27703,
USA.

Manufactured By:
Intas Pharmaceuticals Limited,
Ahmedabad -380 054, India.

10 0533 4 6023293

Issued April 2023

Distributed by:

Advanced Rx Pharmacy of Tennessee, LLC

Spl Medguide

MEDICATION GUIDE Clonazepam Tablets USP (kloe-NA-za-pam) for oral use
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 4/2023
What is the most important information I should know about Clonazepam tablets? Clonazepam 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: shallow or slowed breathing breathing stops (which may lead to the heart stopping) excessive sleepiness (sedation) Do not drive or operate heavy machinery until you know how taking clonazepam tablets and opioids affects you. Risk of abuse, misuse, and addiction.There is a risk of abuse, misuse, and addiction with benzodiazepines, including clonazepam 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 clonazepam 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 clonazepam tablets as prescribed by your healthcare provider. Take clonazepam tablets exactly as your healthcare provider prescribed. Do not share your clonazepam tablets with other people. Keep clonazepam tablets in a safe place and away from children. Physical dependence and withdrawal reactions.Clonazepam tablets can cause physical dependence and withdrawal reactions. Do not suddenly stop taking clonazepam tablets.Stopping clonazepam 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 clonazepam tablets than prescribed or take clonazepam tablets for longer than prescribed. Clonazepam tablets can make you sleepy or dizzy and can slow your thinking and motor skills. This may get better over time. Do not drive, operate heavy machinery, or do other dangerous activities until you know how clonazepam affects you. Clonazepam tablets may cause problems with your coordination, especially when you are walking or picking things up. Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking clonazepam tablets until you talk to your healthcare provider.When taken with alcohol or drugs that cause sleepiness or dizziness, clonazepam tablets may make your sleepiness or dizziness worse. Like other antiepileptic medicines, clonazepam 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 new or worse anxiety trouble sleeping (insomnia) acting on dangerous impulses	attempts to commit suicide feeling agitated or restless new or worse irritability an extreme increase in activity and talking (mania)	new or worse depression panic attacks acting aggressive, being angry, or violent 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. 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. Do not stop clonazepam tablets without first talking to a healthcare provider. Stopping clonazepam tablets suddenly can cause serious problems. Stopping clonazepam tablets suddenly can cause seizures that will not stop (status epilepticus).
What is Clonazepam tablets? Clonazepam tablets is a prescription medicine used alone or with other medicines to treat: certain types of seizure disorders (epilepsy) in adults and children panic disorder with or without fear of open spaces (agoraphobia) in adults Clonazepam tablets are a federally controlled substance (C-IV) because it contains clonazepam that can be abused or lead to dependence.Keep clonazepam tablets in a safe place to prevent misuse and abuse. Selling or giving away clonazepam tablets 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 tablets is safe or effective in treating panic disorder in children younger than 18 years old.
Who should not take Clonazepam tablets? Do not take clonazepam tablets if you: are allergic to benzodiazepines have significant liver disease 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 tablets, tell your healthcare provider if you: have liver or kidney problems have lung problems (respiratory disease) have or have had depression, mood problems, or suicidal thoughts or behavior have any other medical problems are pregnant or plan to become pregnant. Taking clonazepam tablets 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). Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with clonazepam tablets. If you become pregnant while taking clonazepam 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. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy. are breastfeeding or plan to breastfeed. Clonazepam can pass into breast milk. Breastfeeding during treatment with clonazepam tablets may cause your baby to have sleepiness, feeding problems, and decreased weight gain. Talk to your healthcare provider about the best way to feed your baby while you take clonazepam tablets.
Tell your healthcare provider about all the medicines you take,including prescription and over-the- counter medicines, vitamins, and herbal supplements. Taking clonazepam tablets with certain other medicines can cause side effects or affect how well clonazepam tablets or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.
How should I take clonazepam tablets? Take clonazepam tablets exactly as your healthcare provider tells you. If you take clonazepam tablets for seizures, your healthcare provider may change the dose until you are taking the right amount of medicine to control your symptoms. Clonazepam tablets are available as a tablet. Do not stop taking clonazepam tablets without first talking to your healthcare provider. Stopping clonazepam tablets suddenly can cause serious problems. Clonazepam tablets should be taken with water and swallowed whole. If you take too much clonazepam tablets, call your healthcare provider or local Poison Control Center right away.
What should I avoid while taking clonazepam tablets? Clonazepam tablets can slow your thinking and motor skills. Do not drive, operate heavy machinery, or do other dangerous activities until you know how clonazepam tablets affects you. Do not drink alcohol or take other medicines that may make you sleepy or dizzy while taking clonazepam tablets until you talk to your healthcare provider. When taken with alcohol or medicines that cause sleepiness or dizziness, clonazepam tablets may make your sleepiness or dizziness much worse.
What are the possible side effects of clonazepam tablets? See “What is the most important information I should know about clonazepam tablets?” Clonazepam tablets 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 tablets. The most common side effects of clonazepam tablets include:
drowsiness problems with walking and coordination	dizziness depression	fatigue problems with memory
These are not all the possible side effects of clonazepam tablets. 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 the Safety Call Center at 1-866-788-3904.
How should I store clonazepam tablets? Store clonazepam tablets between 59°F to 86°F (15°C to 30°C) Keep clonazepam tablets and all medicines out of the reach of children
General Information about the safe and effective use of clonazepam tablets Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use clonazepam tablets for a condition for which it was not prescribed. Do not give clonazepam tablets 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 tablets that is written for health professionals. For more information, go to www.accordhealthcare.usor call Accord Healthcare Inc. at 1-866-941-7875.
What are the ingredients in clonazepam tablets? Active ingredient:clonazepam Inactive ingredients: Tablets: 0.5 mg tablets contain anhydrous lactose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, starch (corn) and FD&C Yellow No. 6 Lake. 1 mg tablets contain anhydrous lactose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, starch (corn) and FD&C Blue No. 2 Lake. 2 mg tablets contain anhydrous lactose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and starch (corn) Medication guide available at https://www.accordhealthcare.us/medication-guides
Manufactured For: Accord Healthcare, Inc., 1009 Slater Road, Suite 210-B, Durham, NC 27703, USA. Manufactured By: Intas Pharmaceuticals Limited, Ahmedabad -380 054, India. 10 0533 4 6023293

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