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Librax 5-2.5mg Capsules
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Product ID: **LIBRAX
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Product Summary

PRESCRIPTION REQUIRED


IMPORTANT: 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.

CLIDINIUM/CHLORDIAZEPOXIDE - ORAL

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

COMMON BRAND NAME(S): Librax

USES: This medication is a combination of 2 drugs, clidinium and chlordiazepoxide. 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.

OTHER USES: 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.

HOW TO USE: Take this medication by mouth, usually 3 to 4 times a day (30 to 60 minutes before meals and at bedtime) or as directed by your doctor. 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. This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as shakiness, sweating, nausea, seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately. 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. Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction. Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Dizziness, drowsiness, weakness, blurred vision, dry eyes, dry mouth, nausea, constipation, and abdominal bloating may occur. If any of these effects persist or worsen, 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 a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener). Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these unlikely but serious side effects occur: decreased sweating, dry/hot/flushed skin, fast/irregular heartbeat, loss of coordination, slurred speech, fainting, uncontrollable/unusual muscle movements, mental/mood changes (such as confusion, agitation, unusual excitement, depression, strange thoughts), eye pain, vision changes, difficulty urinating, decreased sexual ability, slow/shallow breathing. Tell your doctor immediately if any of these rare but serious side effects occur: signs of infection (such as fever, persistent sore throat), signs of liver problems (dark urine, persistent nausea, vomiting, stomach/abdominal pain, yellowing eyes/skin, unusual tiredness). A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to clidinium or chlordiazepoxide; 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: glaucoma, enlarged prostate, problems with urination due to a blocked urinary tract, 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, congestive 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, drug/alcohol abuse, 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 cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages. This medication may make you sweat less which can increase your risk for heat stroke, a very serious condition. Avoid activities that might cause you to overheat (such as doing strenuous work/exercise in hot weather, using hot tubs). Drink plenty of fluids, and dress lightly while in hot weather or when exercising. If you become overheated, stop exercising and promptly seek cooler shelter. Seek immediate medical attention if you develop a fever, mental/mood changes, headache, or dizziness. 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. This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details. If you become pregnant or think you may be pregnant while taking this medication, tell your doctor immediately. This medication passes into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also the How to Use section. The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring. To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using 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 metoclopramide, pramlintide). This medication may affect the absorption of other products such as levodopa, 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. Many other drugs that also cause dry mouth and constipation may interact with anticholinergics/antispasmodics such as clidinium. Tell your doctor or pharmacist about all the products you take, including: amantadine, other anticholinergic drugs (such as atropine, glycopyrrolate, scopolamine), other antispasmodic drugs (such as dicyclomine, propantheline), belladonna alkaloids, certain drugs used to treat Parkinson's disease (such as benztropine, trihexyphenidyl), certain drugs used to treat irregular heart rhythms (such as disopyramide, quinidine), MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), phenothiazines (such as chlorpromazine), tricyclic antidepressants (such as amitriptyline). Tell your doctor or pharmacist if you are taking other products that cause drowsiness or slow/shallow breathing including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), kava, drugs to treat mental/mood conditions, muscle relaxants, and narcotic pain relievers (such as codeine). 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 laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug. This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. 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.

NOTES: 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 an extended period of time, laboratory and/or medical tests (such as blood counts, liver function tests) may be performed periodically to check for side effects. Consult your doctor for more details.

MISSED DOSE: 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 and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product.

Information last revised September 2011. Copyright(c) 2011 First Databank, Inc.

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