Librax (with clidinium) 5 mg-2.5 mg capsule

Generic name:
Clidinium/chlordiazepoxide - oral

Pronunciation
(kli-DIN-ee-um/KLOR-dye-AZ-e-POX-ide)

Brand name(s)
Librax

Chlordiazepoxide has a risk for abuse and addiction, which can lead to overdose and death. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems (especially opioid medications such as codeine, hydrocodone) may cause very serious side effects, including death. To lower your risk, your doctor should have you take the smallest dose of chlordiazepoxide that works, and take it for the shortest possible time. Be sure you know how to take chlordiazepoxide and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.

Suddenly stopping this medication may cause serious (possibly fatal) withdrawal, especially if you have used it for a long time or in high doses. To prevent withdrawal, your doctor may lower your dose slowly. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as headaches, trouble sleeping, restlessness, hallucinations/confusion, depression, nausea, or seizures. Withdrawal symptoms may sometimes last weeks to months.

This medication is a combination of 2 drugs, clidinium and chlordiazepoxide. It is used along with other medications to help treat stomach/intestinal disorders (such as ulcers, irritable bowel syndrome, bowel infections). Clidinium helps to reduce the symptoms of stomach and intestinal cramping. It works by slowing the natural movements of the gut and by relaxing the muscles in the stomach and intestines. Clidinium belongs to a class of drugs known as anticholinergics/antispasmodics. Chlordiazepoxide helps to reduce anxiety. It acts on the brain and nerves to produce a calming effect. It belongs to a class of drugs known as benzodiazepines.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to relieve the symptoms of irritable bowel syndrome.

See also Warning section.

Read the Medication Guide provided by your pharmacist before you start taking clidinium/chlordiazepoxide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually 3 to 4 times a day (30 to 60 minutes before meals and at bedtime).

If you are taking an antacid, take it after meals and take this medication before meals.

The dosage is based on your age, medical condition, and response to treatment. Older adults usually start with a lower dose to decrease the risk of side effects.

Do not increase your dose or take this drug more often without your doctor's approval. Your condition will not improve any faster and the risk of serious side effects may increase.

When this medication is used for a long time, it may not work as well. Your doctor may need to increase your dose or change your medication. Talk with your doctor if this medication stops working well.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

Tell your doctor if your condition lasts or gets worse.

See also Warning section.

Dizziness, drowsiness, weakness, blurred vision, dry eyes, dry mouth, nausea, constipation, and abdominal bloating may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute. To relieve dry eyes, consult your pharmacist for artificial tears or other eye lubricants.

To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• decreased sweating
• dry/hot/flushed skin
• fast/irregular heartbeat
• loss of coordination
• trouble speaking
• fainting
• uncontrollable/unusual muscle movements
• mental/mood changes (such as confusion, agitation, unusual excitement, depression, strange thoughts)
• difficulty urinating
• decreased sexual ability
• signs of infection (such as sore throat that doesn't go away, fever)
• signs of liver problems (nausea that doesn't stop, dark urine, vomiting, stomach/abdominal pain, yellowing eyes/skin, unusual tiredness)

Get medical help right away if you have any very serious side effects, including:

• eye pain/swelling/redness
• vision changes (such as seeing rainbows around lights at night)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this medication, tell your doctor or pharmacist if you are allergic to clidinium or chlordiazepoxide; or to other benzodiazepines (such as diazepam, lorazepam); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• personal or family history of glaucoma (angle-closure type)
• difficulty urinating (such as due to an enlarged prostate)
• other stomach/intestinal problems (such as slow gut, blockage, ulcerative colitis, infection, little/no stomach acid, ileostomy/colostomy patients with diarrhea)
• overactive thyroid
• heart problems (such as coronary artery disease, angina, heart failure, fast/irregular heartbeat, heart problems due to severe bleeding)
• high blood pressure
• heartburn problems (such as acid reflux, hiatal hernia, esophagus problems)
• a certain nervous system problem (autonomic neuropathy)
• myasthenia gravis
• liver problems
• kidney problems
• breathing/lung problems
• personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol)
• mental/mood conditions (such as depression, thoughts of suicide, psychosis, schizophrenia)
• a certain blood disorder (porphyria)

This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, confusion, unusual excitement, memory problems, constipation, urination problems, and unsteadiness. Drowsiness, confusion, and unsteadiness can increase the risk of falling.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using clidinium/chlordiazepoxide. This medication may harm an unborn baby. Newborn babies of mothers who use this medication late in pregnancy may have symptoms such as slow/shallow breathing, nonstop crying, shaking, or trouble feeding. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

See also Warning and How to Use sections.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• potassium tablets/capsules
• sodium oxybate
• drugs that are affected by slowed gut movement (such as pramlintide)

This medication may affect the absorption of other products such as certain azole anti-fungal drugs (ketoconazole, itraconazole), slowly-dissolving forms of digoxin, among others. If you are taking either ketoconazole or itraconazole, take it at least 2 hours before this medication.

Other medications can affect the removal of chlordiazepoxide from your body, which may affect how this drug works. Examples include cimetidine, disulfiram, among others.

Cigarette smoking decreases blood levels of chlordiazepoxide. Tell your doctor if you smoke or if you have recently stopped smoking.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products, diet aids) because they may contain ingredients that cause drowsiness or a fast heartbeat. Ask your pharmacist about using those products safely.

This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe drowsiness, hot/dry skin, fever, severe dizziness, severe thirst, mental/mood changes (such as confusion, unusual excitement), fast/irregular heartbeat, muscle weakness, inability to move (paralysis), slowed breathing, fainting, seizures.

Do not share this medication with others.

Management of digestive disorders may include lifestyle changes such as stress reduction programs, exercise, stopping smoking, and dietary changes, in addition to medication. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.

If this medication is used for a long time, lab and/or medical tests (such as blood counts, liver function) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.