LIBRAX- chlordiazepoxide hydrochloride and clidinium bromide capsule 
Bausch Health US LLC

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Medication Guide

MEDICATION GUIDE

Librax® (lee braks)

(chlordiazepoxide hydrochloride and clidinium bromide) Capsules

for oral use

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

Librax contains a benzodiazepine medicine. Taking Librax with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death. Get emergency help right away if any of the following happens:
shallow or slowed breathing
breathing stops (which may lead to the heart stopping)
excessive sleepiness (sedation)
 
Do not drive or operate heavy machinery until you know how taking Librax with opioids affects you.
Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including Librax, which can lead to overdose or death.
Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including Librax. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.
You can develop an addiction even if you take Librax as prescribed by your healthcare provider.
Take Librax exactly as your healthcare provider prescribed.
Do not share your Librax with other people.
Keep Librax in a safe place and away from children.
Physical dependence and withdrawal reactions. Librax can cause physical dependence and withdrawal reactions.
Do not suddenly stop using Librax. Stopping Librax suddenly can cause serious and life-threatening side effects, including unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms.
Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months, including anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitches, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.
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.
Do not take more Librax than prescribed or take Librax for longer than prescribed.

What is Librax?

Librax is a prescription medicine that is used with other therapies for the treatment of:
stomach (peptic) ulcers
irritable bowel syndrome (IBS)
inflammation of the colon called acute enterocolitis
Librax contains the medicines chlordiazepoxide hydrochloride and clidinium bromide.
Librax contains chlordiazepoxide hydrochloride that 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.
It is not known if Librax is safe and effective in children.

Do not take Librax if you:

have glaucoma
have an enlarged prostate
have a blockage of your bladder that causes problems with urination
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:

have eye problems
have problems urinating or emptying your bladder
have coordination problems
have kidney or liver problems
have a history of depression, mental illness, or suicidal thoughts
have a history of drug or alcohol abuse or addiction
have bleeding problems
are pregnant or plan to become pregnant. Librax may harm your unborn baby.
Taking Librax late in pregnancy may cause your baby to have symptoms of sedation (breathing problems, sluggishness, low muscle tone), and/or withdrawal symptoms (jitteriness, irritability, restlessness, shaking, excessive crying, feeding problems).
Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Librax.
are breastfeeding or plan to breastfeed. Librax may pass through your breast milk and may cause sedation, poor feeding or poor weight gain in 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:

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

How should I take Librax?

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

Librax can make you sleepy or dizzy and can slow your thinking and motor skills.
Do not drive, operate heavy machinery, or do other dangerous activities until you know how Librax affects you.
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.

The most common side effects of Librax include:

dry mouth
blurred vision
nausea
constipation
skin problems
swelling
irregular menstrual (periods) cycles
increase and decreased desire for sex (libido)
problems starting to urinate
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?

Store Librax at room temperature 77°F (25°C).
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 take 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 ingredients: chlordiazepoxide hydrochloride and clidinium bromide

Inactive ingredients: corn starch, lactose monohydrate, 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, titanium dioxide, and gelatin.

Distributed by:
Bausch Health US, LLC
Bridgewater, NJ 08807 USA

Manufactured by:
Bausch Health Companies Inc.
Steinbach, MB R5G 1Z7, Canada

For more information, go to bauschhealth.com or contact Bausch Health US, LLC at 1-800-321-4576.

Librax is a trademark of Bausch Health Companies Inc. or its affiliates.

© 2023 Bausch Health Companies Inc. or its affiliates

 
This Medication Guide has been approved by the U.S. Food and Drug Administration.
9548904
20003147
 
Revised: 01/2023
Revised: 1/2023
Bausch Health US LLC