CLONAZEPAM- clonazepam tablet, orally disintegrating 
Barr Laboratories Inc.

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Medication Guide

CLONAZEPAM (kloe-NA-za-pam)

ORALLY DISINTEGRATING TABLETS USP CIV

Rx only

Read this Medication Guide before you start taking clonazepam orally disintegrating tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Clonazepam orally disintegrating tablets can cause serious side effects. Because stopping clonazepam orally disintegrating tablets suddenly can also cause serious problems, do not stop taking clonazepam orally disintegrating tablets without talking to your healthcare provider first.

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

Do not stop taking clonazepam orally disintegrating tablets without first talking to your healthcare provider.

Stopping clonazepam orally disintegrating tablets suddenly can cause serious problems.

Clonazepam orally disintegrating tablets can cause serious side effects, including:

1.Clonazepam orally disintegrating tablets can slow your thinking and motor skills

Do not drive, operate heavy machinery, or do other dangerous activities until you know how clonazepam orally disintegrating tablets affect you.
Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking clonazepam orally disintegrating tablets until you talk to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, clonazepam orally disintegrating tablets may make your sleepiness or dizziness worse.

2.Like other antiepileptic drugs, clonazepam orally disintegrating 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:

thoughts about suicide or dying
attempt to commit suicide
new or worse depression
new or worse anxiety
feeling agitated or restless
panic attacks
trouble sleeping (insomnia)
new or worse 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.

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 orally disintegrating tablets without first talking to a healthcare provider.

Stopping clonazepam orally disintegrating tablets suddenly can cause serious problems. Stopping clonazepam orally disintegrating tablets suddenly can cause seizures that will not stop (status epilepticus).

3.Clonazepam orally disintegrating tablets may harm your unborn or developing baby.

If you take clonazepam orally disintegrating tablets during pregnancy, your baby is at risk for serious birth defects. These defects can happen as early as in the first month of pregnancy, even before you know you are pregnant. Birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors.
Children born to mothers receiving benzodiazepine medications (including clonazepam orally disintegrating tablets) late in pregnancy may be at some risk of experiencing breathing problems, feeding problems, hypothermia, and withdrawal symptoms.
Tell your healthcare provider right away if you become pregnant while taking clonazepam orally disintegrating tablets. You and your healthcare provider should decide if you will take clonazepam orally disintegrating tablets while you are pregnant.
If you become pregnant while taking clonazepam orally disintegrating 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.
Clonazepam orally disintegrating tablets can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take clonazepam orally disintegrating tablets. You and your healthcare provider should decide if you will take clonazepam orally disintegrating tablets or breast feed. You should not do both.

4.Clonazepam orally disintegrating tablets can cause abuse and dependence.

Do not stop taking clonazepam orally disintegrating tablets all of a sudden. Stopping clonazepam orally disintegrating tablets suddenly can cause seizures that do not stop, hearing or seeing things that are not there (hallucinations), shaking, and stomach and muscle cramps.
Talk to your doctor about slowly stopping clonazepam orally disintegrating tablets to avoid getting sick with withdrawal symptoms.
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.

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

What are clonazepam orally disintegrating tablets?

Clonazepam orally disintegrating tablets are 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

It is not known if clonazepam orally disintegrating tablets are safe or effective in treating panic disorder in children younger than 18 years old.

Who should not take clonazepam orally disintegrating tablets?

Do not take clonazepam orally disintegrating 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.

What should I tell my healthcare provider before taking clonazepam orally disintegrating tablets?

Before you take clonazepam orally disintegrating 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 conditions

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking clonazepam orally disintegrating tablets with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take clonazepam orally disintegrating tablets?

Take clonazepam orally disintegrating tablets exactly as your healthcare provider tells you. Clonazepam is available as a tablet or as an orally disintegrating tablet.
Do not stop taking clonazepam orally disintegrating tablets without first talking to your healthcare provider. Stopping clonazepam orally disintegrating tablets suddenly can cause serious problems.
Clonazepam tablets should be taken with water and swallowed whole.
Clonazepam orally disintegrating tablets can be taken with or without water.
Do not open the blister pack until you are ready to take clonazepam orally disintegrating tablets.
After opening, peel back the foil on the blister pack.
Do not push the orally disintegrating tablet through the foil.
After opening the blister pack, with dry hands, take the orally disintegrating tablet and place it in your mouth.
The orally disintegrating tablet will melt quickly.
If you take too many clonazepam orally disintegrating tablets, call your healthcare provider or local Poison Control Center right away.

What should I avoid while taking clonazepam orally disintegrating tablets?

Clonazepam orally disintegrating tablets can slow your thinking and motor skills. Do not drive, operate heavy machinery, or do other dangerous activities until you know how clonazepam orally disintegrating tablets affect you.
Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking clonazepam orally disintegrating tablets until you talk to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, clonazepam orally disintegrating tablets may make your sleepiness or dizziness worse.

What are the possible side effects of clonazepam orally disintegrating tablets?

See “What is the most important information I should know about clonazepam orally disintegrating tablets?”

Clonazepam orally disintegrating 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 orally disintegrating tablets.

The most common side effects of clonazepam orally disintegrating tablets include:

Drowsiness
Problems with walking and coordination
Dizziness
Depression
Fatigue
Problems with memory

These are not all the possible side effects of clonazepam orally disintegrating tablets. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or drug.safety@tevapharm.com.

How should I store clonazepam orally disintegrating tablets?

Store clonazepam orally disintegrating tablets between 68°F to 77°F (20°C to 25°C).

Keep clonazepam orally disintegrating tablets and all medicines out of the reach of children.

General Information about clonazepam orally disintegrating tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use clonazepam orally disintegrating tablets for a condition for which they were not prescribed. Do not give clonazepam orally disintegrating tablets to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about clonazepam orally disintegrating tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about clonazepam orally disintegrating tablets that is written for health professionals.

For more information, call 1-888-838-2872.

What are the ingredients in clonazepam orally disintegrating tablets?

Active ingredient: clonazepam

Inactive ingredients: aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, sodium stearyl fumarate, strawberry flavor and xylitol.

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

TEVA PHARMACEUTICALS USA, INC.
North Wales, PA 19454

Rev. D 8/2015

Revised: 12/2015
Barr Laboratories Inc.