Medication Guide

Clonazepam Orally Disintegrating Tablets

CIV

Read this Medication Guide before you start taking clonazepam 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 can cause serious side effects. Because stopping clonazepam suddenly can also cause serious problems, do not stop taking clonazepam without talking to your healthcare provider first.

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

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

Stopping clonazepam suddenly can cause serious problems.

Clonazepam can cause serious side effects, including:

1. Clonazepam can slow your thinking and motor skills
   • Do not drive, operate heavy machinery, or do other dangerous activities until you know how clonazepam affects you.
   • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking clonazepam until you talk to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, clonazepam may make your sleepiness or dizziness worse.
2. Like other antiepileptic drugs, clonazepam 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 without first talking to a healthcare provider.

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

3. Clonazepam may harm your unborn or developing baby.

• If you take clonazepam 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) 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. You and your healthcare provider should decide if you will take clonazepam while you are pregnant.
• If you become pregnant while taking clonazepam, 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 can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take clonazepam. You and your healthcare provider should decide if you will take clonazepam or breast feed. You should not do both.

4. Clonazepam can cause abuse and dependence.

• Do not stop taking clonazepam all of a sudden. Stopping clonazepam 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 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 is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep clonazepam in a safe place to prevent misuse and abuse. Selling or giving away clonazepam 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 is clonazepam?

Clonazepam 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

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

Who should not take clonazepam?

Do not take clonazepam 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?

Before you take clonazepam, 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 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?

• Take clonazepam exactly as your healthcare provider tells you. Clonazepam is available as an orally disintegrating tablet.
• Do not stop taking clonazepam without first talking to your healthcare provider. Stopping clonazepam suddenly can cause serious problems.
• Clonazepam tablets should be taken with water and swallowed whole.
• If you take too much clonazepam, call your healthcare provider or local Poison Control Center right away.

What should I avoid while taking clonazepam?

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

What are the possible side effects of clonazepam?

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

Clonazepam 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.

The most common side effects of clonazepam include:

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

These are not all the possible side effects of clonazepam. 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 Par Pharmaceutical at www.parpharm.com or call 1-800-828-9393.

How should I store clonazepam?

• Store clonazepam between 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature].

Keep clonazepam and all medicines out of the reach of children.

General Information about clonazepam

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use clonazepam for a condition for which it was not prescribed. Do not give clonazepam 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. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about clonazepam that is written for health professionals.

For more information, go to www.parpharm.com or call 1-800-828-9393.

What are the ingredients in clonazepam?

Active ingredient: clonazepam

Inactive ingredients:

• Tablets:
  • 0.125 mg tablets contain aspartame, crospovidone, magnesium stearate, mannitol, silicon dioxide, sorbitol, sodium lauryl sulfate and talc
  • .25 mg tablets contain aspartame, crospovidone, magnesium stearate, mannitol, silicon dioxide, sorbitol, sodium lauryl sulfate and talc
  • .5 mg tablets contain aspartame, crospovidone, magnesium stearate, mannitol, silicon dioxide, sorbitol, sodium lauryl sulfate and talc
  • 1 mg tablets contain contain aspartame, crospovidone, magnesium stearate, mannitol, silicon dioxide, sorbitol, sodium lauryl sulfate and talc
  • 2 mg tablets contain aspartame, crospovidone, magnesium stearate, mannitol, silicon dioxide, sorbitol, sodium lauryl sulfate and talc

MG Issued: November 2010

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

Distributed by:

Par Pharmaceutical Inc.

One Ram Ridge Rd.

Spring Valley, NY 10977

For additional copies of this Medication Guide, visit www.parpharm.com or call 1-800-828-9393.

Representative sample of labeling (see HOW SUPPLIED section for complete listing):

ATTENTION PHARMACIST: Dispense the accompanying Medication Guide to each patient. For additional copies of this Medication Guide, visit www.parpharm.com or call 1-800-828-9393