Issued: 02/2017

MEDICATION GUIDE
Chlordiazepoxide Hydrochloride/Clidinium Bromide capsules

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

•

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

•

**Taking Chlordiazepoxide Hydrochloride/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.**

•

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

•

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

•

**Chlordiazepoxide Hydrochloride/Clidinium Bromide can cause abuse and dependence**. 

•

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

•

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 Hydrochloride/Clidinium Bromide?

•

Chlordiazepoxide Hydrochloride/Clidinium Bromide 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

•

The product contains chlordiazepoxide hydrochloride and clidinium bromide.

•

**Chlordiazepoxide Hydrochloride/Clidinium Bromide can be abused or lead to dependence**. Keep Chlordiazepoxide Hydrochloride/Clidinium Bromide in a safe place to prevent misuse and abuse. Selling or giving away Chlordiazepoxide Hydrochloride/Clidinium Bromide 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 Chlordiazepoxide Hydrochloride/Clidinium Bromide is safe and effective in children.

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

•

are breastfeeding or plan to breastfeed. Chlordiazepoxide Hydrochloride/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 Hydrochloride/Clidinium Bromide capsules. Chlordiazepoxide Hydrochloride/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 Hydrochloride/Clidinium Bromide with certain other medicines can cause side effects or affect how well Chlordiazepoxide Hydrochloride/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:

•

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

How should I take Chlordiazepoxide Hydrochloride/Clidinium Bromide capsules?

•

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

•

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

•

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

What are the possible side effects of Chlordiazepoxide Hydrochloride/Clidinium Bromide capsules?
Chlordiazepoxide Hydrochloride/Clidinium Bromide may cause serious side effects, including: See "What is the most important information I should know about Chlordiazepoxide Hydrochloride/Clidinium Bromide capsules?"
The most common side effects of Chlordiazepoxide Hydrochloride/Clidinium Bromide 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 Chlordiazepoxide Hydrochloride/Clidinium Bromide capsules.  

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 Hydrochloride/Clidinium Bromide capsules?

•

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

•

**Keep Chlordiazepoxide Hydrochloride/Clidinium Bromide capsules and all medicines out of the reach of children.**

**General information about the safe and effective use of Chlordiazepoxide Hydrochloride/Clidinium Bromide capsules.**   

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Chlordiazepoxide Hydrochloride/Clidinium Bromide capsules for a condition for which it was not prescribed. Do not give Chlordiazepoxide Hydrochloride/Clidinium Bromide capsules 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 Hydrochloride/Clidinium Bromide capsules that is written for health professionals.
** Active ingredient:** chlordiazepoxide hydrochloride and clidinium bromide
** Inactive ingredients:** lactose monohydrate, pregelatinized starch, talc. Gelatin capsule shells may contain titanium dioxide with the following dye systems: D&C Yellow #10, FD&C Green #3 and gelatin.
Manufactured for: Virtus Pharmaceuticals OPCO II, LLC
Nashville, TN 37217
For more information go to www.virtusrx.com or contact Virtus Pharmaceuticals OPCO II, LLC at 1-855-255-6076.