CLOBAZAM- clobazam tablet 
Lupin Pharmaceuticals, 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?

Do not drive or operate heavy machinery until you know how taking clobazam with opioids affects you.

Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

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.

Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

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?

  1. 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.
  2. Clobazam tablets is a federally controlled substance (C-IV) because it contains clobazam that can be abused or lead to dependence. Keep clobazam tablets in a safeplace to prevent misuse and abuse. Selling or giving away clobazam 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 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?

See "What is the most important information I should know about 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:

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. You may also report side effects to Lupin Pharmaceuticals, Inc. at 1-800-399-2561.

How should I store clobazam tablets?

Tablets

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?

Active ingredient: clobazam

Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.

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

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Nagpur - 441108

India

Revised: Aug 2023                                                                                              ID#: 274109

Revised: 11/2023
Lupin Pharmaceuticals, Inc.