Medication Guide

LIBRAX (lee braks)

(chlordiazepoxide HCl and clidinium bromide) capsules

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

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Do not stop taking Librax without first talking to your healthcare provider. Stopping Librax suddenly can cause serious side effects.

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Taking Librax 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 Librax affects you.

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

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Librax can cause abuse and dependence.

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Do not stop taking Librax all of a sudden. Stopping Librax 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 Librax?

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Librax 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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Librax contains the medicines chlordiazepoxide HCl and clidinium bromide.

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Librax can be abused or lead to dependence. Keep Librax in a safe place to prevent misuse and abuse. Selling or giving away Librax 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 Librax is safe and effective in children.

Do not take Librax 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 Librax, 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. Librax may harm your unborn baby. Avoid taking Librax during the first trimester of pregnancy. Tell your healthcare provider right away if you become pregnant during treatment with Librax.

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are breastfeeding or plan to breastfeed. Librax 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 Librax. Librax 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 Librax with certain other medicines can cause side effects or affect how well Librax 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 Librax?

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Take Librax exactly as your healthcare provider tells you to take it.

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Your healthcare provider may change your dose of Librax if needed. Do not change your dose of Librax or suddenly stop taking Librax without talking with your healthcare provider.

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If you take too much Librax, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of Librax?

Librax may cause serious side effects, including: See “What is the most important information I should know about Librax?”

The most common side effects of Librax include:

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dry mouth

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blurred vision

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nausea

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constipation

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skin problems

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swelling

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irregular menstrual (periods) cycles

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increase 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 Librax.

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 Librax?

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Store Librax at room temperature 77°F (25°C).

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

General information about the safe and effective use of Librax.

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

What are the ingredients in Librax?

Active ingredient: chlordiazepoxide hydrochloride and clidinium bromide

Inactive ingredients: corn starch, lactose and talc. Gelatin capsule shells may contain methyl and propyl parabens and potassium sorbate, with the following dye systems: D&C Yellow No. 10 and either FD&C Blue No.1 or FD&C Green No. 3.

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

Manufactured for: Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA

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

Issued: 01/2017