CLOBAZAM- clobazam tablet 
Breckenridge Pharmaceutical, Inc.

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MEDICATION GUIDE
Clobazam (KLOE-ba-zam) Tablets, CIV

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

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
  • attempts 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?

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.

What are clobazam tablets?

Clobazam Tablets are a prescription medicine used along with other medicines to treat seizures associated with Lennox-Gastaut syndrome in people 2 years of age or older.

It is not known if clobazam tablets are safe and effective in children less than 2 years old.

Do not take clobazam tablets if you:

Before you take clobazam tablets, tell your healthcare provider about all your medical conditions, including if you:

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

How should I take clobazam tablets?

What should I avoid while taking clobazam tablets?

What are the possible side effects of clobazam tablets?

Clobazam Tablets may cause serious side effects, including:

See "What is the most important information I should know about clobazam tablets?"

The most common side effects of clobazam tablets include:

  • sleepiness
  • drooling
  • constipation
  • cough
  • pain with urination
  • fever
  • acting aggressive, being angry, or violent
  • difficulty sleeping
  • slurred speech
  • tiredness
  • problems with breathing

These are not all the possible side effects of clobazam tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store clobazam tablets?

Keep clobazam tablets and all medicines out of the reach of children.

General Information about the safe and effective use of clobazam tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use clobazam tablets for a condition for which it was not prescribed. Do not give clobazam 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 clobazam tablets that is written for health professionals.

What are the ingredients in clobazam tablets?

Tablets

Active ingredient: clobazam

Inactive ingredients: maize starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and talc

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

Manufactured by:
Centaur Pharmaceuticals Pvt. Ltd.
Pune 411057 INDIA.

Distributed by:
Breckenridge Pharmaceutical, Inc.
Berlin, CT 06037.

For more information about clobazam tablets, go to www.bpirx.com or call Breckenridge Pharmaceutical, Inc. at 1-800-367-3395.

Revised: 05/2019

Revised: 6/2020
Breckenridge Pharmaceutical, Inc.