CLONAZEPAM- clonazepam tablet 
Eon Labs, Inc.

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Medication Guide

Clonazepam Tablets USP

CIV symbol

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

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

Do not stop taking Clonazepam Tablets USP without first talking to your healthcare provider. Stopping Clonazepam Tablets USP suddenly can cause serious problems.

Clonazepam Tablets USP can cause serious side effects, including:

1. Clonazepam Tablets USP can slow your thinking and motor skills

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how Clonazepam Tablets USP affects you.

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

2. Like other antiepileptic drugs, Clonazepam Tablets USP 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 Tablets USP without first talking to a healthcare provider.

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

3. Clonazepam Tablets USP may harm your unborn or developing baby.

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

4. Clonazepam Tablets USP can cause abuse and dependence.

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

Clonazepam Tablets USP 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 Tablets USP is safe or effective in treating panic disorder in children younger than 18 years old.

Who should not take Clonazepam Tablets USP?

Do not take Clonazepam Tablets USP 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 Tablets USP?

Before you take Clonazepam Tablets USP, 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 nonprescription medicines, vitamins, and herbal supplements.

Taking Clonazepam Tablets USP 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 Tablets USP?

• Take Clonazepam Tablets USP exactly as your healthcare provider tells you.

Do not stop taking Clonazepam Tablets USP without first talking to your healthcare provider. Stopping Clonazepam Tablets USP suddenly can cause serious problems.
Clonazepam Tablets USP should be taken with water and swallowed whole.

• If you take too much Clonazepam Tablets USP, call your healthcare provider or local Poison Control Center right away.

What should I avoid while taking Clonazepam Tablets USP?

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

What are the possible side effects of Clonazepam Tablets USP?

See “What is the most important information I should know about Clonazepam Tablets USP?”

Clonazepam Tablets USP 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 USP.

The most common side effects of Clonazepam Tablets USP include:

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

These are not all the possible side effects of Clonazepam Tablets USP. 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 Sandoz Inc. at 1-800-525-8747.

How should I store Clonazepam Tablets USP?

Store Clonazepam Tablets USP between 20° to 25°C (68° to 77°F).

Keep Clonazepam Tablets USP and all medicines out of the reach of children.

General Information about Clonazepam Tablets USP

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

What are the ingredients in Clonazepam Tablets USP?

Active ingredient: clonazepam

Inactive ingredients:

0.5 mg tablets contain corn starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, D&C yellow No. 10 aluminum lake
1 mg tablets contain corn starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, FD&C Blue No. 1 aluminum lake
2 mg tablets contain corn starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose

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

Sandoz Inc.

Princeton, NJ 08540

OS7057

Rev. 05/13

MF0063REV05/13

MG #12628

Revised: 03/2014
 
Eon Labs, Inc.