MEDICATION GUIDE

Dispense with Medication Guide available at:

www.solcohealthcare.com/medguide/clonazepam-tablets.pdf

Clonazepam Tablets

for oral use

What is the most important information I should know about clonazepam tablets?

•Clonazepam tablets are 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:oshallow or slowed breathingobreathing stops (which may lead to the heart stopping)oexcessive sleepiness (sedation)Do not drive or operate heavy machinery until you know how taking clonazepamtablets 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.oSerious 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. oYou can develop an addiction even if you take clonazepam tablets as prescribed by your healthcare provider. oTake clonazepam tablets exactly as your healthcare provider prescribed. oDo not share your clonazepamtablets with other people.oKeep clonazepam tablets in a safe place and away from children.•Physical dependence and withdrawal reactions. Clonazepam tablets can cause physical dependence and withdrawal reactions.oDo 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. oSome 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.oPhysical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.oDo 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. oDo not drive, operate heavy machinery, or do other dangerous activities until you know how clonazepam tablets affect you.oClonazepam 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 drugs, clonazepam tablets 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:

othoughts about suicide or dying	oattempts to commit suicide	onew or worse depression
onew or worse anxiety	ofeeling agitated or restless	opanic attacks
otrouble sleeping (insomnia)	onew or worse irritability	oacting aggressive, being angry, or violent
oacting on dangerous impulses	oan extreme increase in activity and talking (mania)	oother unusual changes in behavior or mood

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

oPay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.oKeep 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. oStopping clonazepam tablets suddenly can cause serious problems. Stopping clonazepam tablets suddenly can cause seizures that will not stop (status epilepticus). 

What are clonazepam tablets?

•Clonazepam tablets are a prescription medicine used alone or with other medicines to treat: ocertain types of seizure disorders (epilepsy) in adults and childrenopanic disorder with or without fear of open spaces (agoraphobia) in adults •Clonazepam tablets are 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 are 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.oTaking 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).oTell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with clonazepam tablets.oIf 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.oBreastfeeding during treatment with clonazepam tablets may cause your baby to have sleepiness, feeding problems, and decreased weight gain.oTalk 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 is 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 affect 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 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	•dizziness	•fatigue
•problems with walking and coordination	•depression	•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 Solco Healthcare US, LLC at 1-866-257-2597.

How should I store clonazepam tablets?

•Store clonazepam tablets at room temperature, between 68°F to 77°F (20°C to 25°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.

What are the ingredients in clonazepam tablets?

Active ingredient: clonazepam

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose, with the following colorants: 0.5 mg – D&C Yellow #10 aluminum lake; 1 mg – FD&C Blue #1 aluminum lake.

Manufactured by:
Prinston Laboratories
Charlotte, NC 28206, USA

Distributed by:
Solco Healthcare US, LLC
Somerset, NJ 08873, USA

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: 04/2023