Medication Guide

Chlordiazepoxide HCl/Clidinium Bromide
capsules

What is the most important information I should know about Chlordiazepoxide HCl/Clidinium Bromide?

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Do not stop taking Chlordiazepoxide HCl/Clidinium Bromide without first talking to your healthcare provider. Stopping Chlordiazepoxide HCl/Clidinium Bromide suddenly can cause serious side effects.

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Taking Chlordiazepoxide HCl/Clidinium Bromide with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death.

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Do not drive, operate heavy machinery, or do other dangerous activities until you know how Chlordiazepoxide HCl/Clidinium Bromide affects you.

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Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking Chlordiazepoxide HCl/Clidinium Bromide without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, Chlordiazepoxide HCl/Clidinium Bromide may make your sleepiness or dizziness much worse.

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Chlordiazepoxide HCl/Clidinium Bromide can cause abuse and dependence.

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Do not stop taking Chlordiazepoxide HCl/Clidinium Bromide all of a sudden. Stopping Chlordiazepoxide HCl/Clidinium Bromide suddenly can cause seizures, shaking, stomach and muscle cramps, vomiting and sweating.

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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.

What is Chlordiazepoxide HCl/Clidinium Bromide?

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Chlordiazepoxide HCl/Clidinium Bromide is a prescription medicine that is used with other therapies for the treatment of:

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stomach (peptic) ulcers

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irritable bowel syndrome (IBS)

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inflammation of the colon called acute enterocolitis

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Chlordiazepoxide HCl/Clidinium Bromide contains the medicines chlordiazepoxide HCl and clidinium bromide.

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Chlordiazepoxide HCl/Clidinium Bromide can be abused or lead to dependence. Keep Chlordiazepoxide HCl/Clidinium Bromide in a safe place to prevent misuse and abuse. Selling or giving away Chlordiazepoxide HCl/Clidinium Bromide may harm others. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.

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It is not known if Chlordiazepoxide HCl/Clidinium Bromide is safe and effective in children.

Do not take Chlordiazepoxide HCl/Clidinium Bromide if you:

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have glaucoma

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have an enlarged prostate

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have a blockage of your bladder that causes problems with urination

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are allergic to chlordiazepoxide hydrochloride or clidinium bromide

Before you take Chlordiazepoxide HCl/Clidinium Bromide, tell your healthcare provider about all of your medical conditions, including if you:

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have eye problems

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have problems urinating or emptying your bladder

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have coordination problems

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have kidney or liver problems

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have a history of depression, mental illness, or suicidal thoughts

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have a history of drug or alcohol abuse or addiction

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have bleeding problems

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are pregnant or plan to become pregnant. Chlordiazepoxide HCl/Clidinium Bromide may harm your unborn baby. Avoid taking Chlordiazepoxide HCl/Clidinium Bromide during the first trimester of pregnancy. Tell your healthcare provider right away if you become pregnant during treatment with Chlordiazepoxide HCl/Clidinium Bromide.

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are breastfeeding or plan to breastfeed. Chlordiazepoxide HCl/Clidinium Bromide may pass through your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take Chlordiazepoxide HCl/Clidinium Bromide. Chlordiazepoxide HCl/Clidinium Bromide may decrease the amount of breast milk your body makes.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking Chlordiazepoxide HCl/Clidinium Bromide with certain other medicines can cause side effects or affect how well Chlordiazepoxide HCl/Clidinium Bromide or the other medicines work.

Do not start or stop other medicines without talking to your healthcare provider.

Especially tell your healthcare provider if you:

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take a monoamine oxidase inhibitor (MAOI) medicine or an anti-psychotic medicine called phenothiazine.

How should I take Chlordiazepoxide HCl/Clidinium Bromide?

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Take Chlordiazepoxide HCl/Clidinium Bromide exactly as your healthcare provider tells you to take it.

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Your healthcare provider may change your dose of Chlordiazepoxide HCl/Clidinium Bromide if needed. Do not change your dose of Chlordiazepoxide HCl/Clidinium Bromide or suddenly stop taking Chlordiazepoxide HCl/Clidinium Bromide without talking with your healthcare provider.

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If you take too much Chlordiazepoxide HCl/Clidinium Bromide, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of Chlordiazepoxide HCl/Clidinium Bromide?

Chlordiazepoxide HCl/Clidinium Bromide may cause serious side effects, including: See "What is the most important information I should know about Chlordiazepoxide HCl/Clidinium Bromide?"

The most common side effects of Chlordiazepoxide HCl/Clidinium Bromide include:

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dry mouth

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nausea

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skin problems

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blurred vision

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constipation

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swelling

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irregular menstrual (periods) cycles

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increased and decreased desire for sex (libido)

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problems starting to urinate

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drowsiness, coordination problems, and confusion may happen, especially in people who are elderly or weak

These are not all the possible side effects of Chlordiazepoxide HCl/Clidinium Bromide.

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 Chlordiazepoxide HCl/Clidinium Bromide?

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Store Chlordiazepoxide HCl/Clidinium Bromide at room temperature 77°F (25°C).

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Keep Chlordiazepoxide HCl/Clidinium Bromide and all medicines out of the reach of children.

General information about the safe and effective use of Chlordiazepoxide HCl/Clidinium Bromide.

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

What are the ingredients in Chlordiazepoxide HCl/Clidinium Bromide?

Active ingredient: chlordiazepoxide hydrochloride and clidinium bromide

Inactive ingredients: corn starch, lactose and talc. Gelatin capsule shells may contain methylparaben, propylparaben, and potassium sorbate, with the following dye systems: D&C Yellow No. 10 and FD&C Green No. 3.

Distributed by: Cameron Pharmaceuticals
Louisville, KY 40245 USA

Manufactured by: Valeant Pharmaceuticals International, Inc.
Steinbach, MB R5G 1Z7 Canada

Librax is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.

©Valeant Pharmaceuticals North America LLC

For more information, go to www.valeant.com or contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576.

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

Revised: 04/2017

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