Chlordiazepoxide and clidinium

LIBRAX
(lee braks)
(chlordiazepoxide HCl and clidinium bromide) Capsules

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

• Do not stop taking Librax without first talking to your healthcare provider. Stopping Librax suddenly can cause serious side effects.
• 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.
  • 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.
• Librax can cause abuse and dependence.
  • Do not stop taking Librax all of a sudden. Stopping Librax 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 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 HCl and clidinium bromide.
• 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.
• 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. Avoid taking Librax during the first trimester of pregnancy. Tell your healthcare provider right away if you become pregnant during treatment with Librax.
• 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-thecounter 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?”

The most common side effects of Librax include:

• dry mouth
• nausea
• skin problems
• blurred vision
• constipation
• 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 1-800FDA-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 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.

• Anxiety

You should not use this medicine if you have glaucoma, an enlarged prostate, bladder obstruction, or problems with urination.

You should not use this medicine if you are allergic to chlordiazepoxide or clidinium, or if you have:

• glaucoma;

• an enlarged prostate;

• bladder obstruction; or

• problems with urination.

To make sure chlordiazepoxide and clidinium is safe for you, tell your doctor if you have:

• liver or kidney disease;

• a history of depression or suicidal thoughts or behavior;

• a history of drug or alcohol addiction; or

• if you use a narcotic (opioid) medication.

Chlordiazepoxide can cause birth defects in an unborn baby. Tell your doctor if you are pregnant or if you become pregnant while using this medicine. Use an effective form of birth control while you are using this medication.

Chlordiazepoxide and clidinium may pass into breast milk and could harm a nursing baby. This medicine may also slow breast milk production. Tell your doctor if you are breast-feeding a baby.

The sedative effects of this medicine may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are taking chlordiazepoxide and clidinium.

Chlordiazepoxide and clidinium is not approved for use by anyone younger than 18 years old.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Chlordiazepoxide and clidinium is usually taken before meals and at bedtime. Follow your doctor's instructions.

Chlordiazepoxide may be habit-forming. Never share chlordiazepoxide and clidinium with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using chlordiazepoxide and clidinium.

Call your doctor if your symptoms do not improve, or if they get worse.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Chlordiazepoxide and clidinium is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Avoid drinking alcohol. Dangerous side effects could occur.

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe drowsiness;

• a light-headed feeling, like you might pass out;

• problems with balance or coordination;

• confusion, excitement, anger, or feeling restless;

• severe constipation;

• painful or difficult urination;

• restless muscle movements in your eyes, tongue, jaw, or neck;

• fever, sore throat; or

• jaundice (yellowing of the skin or eyes).

Side effects may be more likely in older adults.

Common side effects may include:

• dry mouth;

• blurred vision;

• constipation, nausea;

• urination problems;

• drowsiness;

• rash;

• swelling;

• irregular menstrual periods; or

• increased or decreased interest in sex.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Chlordiazepoxide and clidinium combination is used in combination with other medicines to treat stomach or bowel problems such as peptic ulcers, irritable bowel syndrome (IBS), and enterocolitis (inflammation of the colon and small intestines).

Chlordiazepoxide is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system. Clidinium is an anticholinergic agent. It reduces stomach acid and decreases bowel spasms.

chlordiazepoxide and clidinium is available only with your doctor's prescription.

It is very important that your doctor check your progress at regular visits to make sure chlordiazepoxide and clidinium is working properly. Blood tests may be needed to check for unwanted effects.

Using chlordiazepoxide and clidinium while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using chlordiazepoxide and clidinium.

chlordiazepoxide and clidinium may cause some people, especially elderly patients, to become drowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than they are normally. Make sure you know how you react to chlordiazepoxide and clidinium before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think or see well.

Check with your doctor before using chlordiazepoxide and clidinium with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with Librax® may worsen the side effects of chlordiazepoxide and clidinium, such as dizziness, irregular, fast or slow, or shallow breathing, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

If you develop any unusual and strange thoughts or behavior while you are taking chlordiazepoxide, be sure to discuss it with your doctor. Some changes that have occurred in people taking chlordiazepoxide and clidinium are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, suicidal thoughts, and unusual excitement, nervousness, or irritability.

Do not suddenly stop taking chlordiazepoxide and clidinium without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a worsening of your condition and reduce the possibility of withdrawal symptoms, such as convulsions (seizures), stomach or muscle cramps, tremors, or unusual behavior.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Applies to chlordiazepoxide / clidinium: oral capsule

Nervous system

The elderly and debilitated may be more susceptible to the side effects of chlordiazepoxide-clidinium. Drowsiness, ataxia, and confusion have occasionally been reported at the lower dosage ranges.[Ref]

Nervous system side effects have included drowsiness, ataxia, confusion, and extrapyramidal symptoms. Chlordiazepoxide-clidinium may impair the psychomotor skills necessary for driving. Changes in electroencephalogram (EEG) patterns (low-voltage fast activity) have been reported during and after chlordiazepoxide treatment.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea, constipation, and dryness of the mouth.[Ref]

Hematologic

Hematologic side effects have included blood dyscrasias (including agranulocytosis).[Ref]

Hepatic

Hepatic side effects have included jaundice and hepatic dysfunction.[Ref]

Other

Other side effects have included increased and decreased libido, edema, and withdrawal symptoms. Rarely, syncope has been reported.[Ref]

Withdrawal symptoms after abrupt cessation of chlordiazepoxide-clidinium may include dysphoria, insomnia, convulsions, tremor, abdominal and muscle cramps, vomiting, sweating, agitation, restlessness, and anxiety.[Ref]

Ocular

Ocular side effects have included blurring of vision.[Ref]

Genitourinary

Genitourinary side effects have included minor menstrual irregularities and urinary hesitancy.[Ref]

Dermatologic

Dermatologic side effects have included skin eruptions.[Ref]

Some side effects of chlordiazepoxide / clidinium may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.