Patient Medication Information: uses, side effects, how to take - Librax
Serious Warnings and Precautions
Addiction, Abuse and Misuse: Even if you take LIBRAX exactly as you were told to, you are at risk for abuse, misuse, addiction, physical dependence and withdrawal. Abuse and misuse can result in overdose or death, especially if you take LIBRAX with:
Your healthcare professional should:
Store LIBRAX in a secure place to avoid theft or misuse. Withdrawal: If you suddenly stop taking LIBRAX, lower your dose too fast, or switch to another medication, you can experience severe or life-threatening withdrawal symptoms (see Other warnings you should know about)
LIBRAX with Opioids: Taking LIBRAX with opioid medicines can cause:
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What is LIBRAX used for?
LIBRAX is used to treat the following conditions when they are associated with anxiety and tension:
- Peptic ulcers (open sores in the lining of your stomach and small intestine)
- Irritable bowel syndrome (irritable colon, spastic colon, mucous colitis)
- Acute entero-colitis (inflammation of the colon)
If you are 65 years or older, talk to your doctor before starting LIBRAX. LIBRAX may not be an effective treatment for you and you may be more sensitive to experiencing side effects.
How does LIBRAX work?
LIBRAX belongs to a group of medications called benzodiazepines. It affects chemical activity in your brain, to help promote sleep and to reduce anxiety and worry. It also works by slowing down the natural movements of your stomach and lower intestine to relieve stomach pain or discomfort. This helps to treat peptic ulcers, irritable bowel syndrome and acute enterocolitis.
What are the ingredients in LIBRAX ?
Medicinal ingredients: chlordiazepoxide hydrochloride and clidinium bromide.
Non-medicinal ingredients: Gelatin, lactose monohydrate, starch, talc, titanium dioxide, D&C Yellow # 10, FD&C Green, black imprinting ink.
LIBRAX comes in the following dosage forms:
Capsule: 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide.
Do not use LIBRAX if:
- you have any heart instability
- you have a history of drug abuse or dependence
- you have angle-closure glaucoma (eye disorder), or are at risk of developing glaucoma
- you have any liver problems
- you have a hiatal hernia (a condition where the top of your stomach bulges through an opening in your diaphragm) with acid reflux
- you are elderly or very weak and have intestinal or bowel problems
- you have an intestinal obstruction
- you have myasthenia gravis (a disease that causes weakness in your muscles)
- you have an enlarged prostate gland or are unable to voluntarily urinate (urinary retention)
- you have ulcerative colitis (an inflammatory bowel disease)
- you are allergic to chlordiazepoxide hydrochloride and/or clidinium bromide, or to any of the ingredients in LIBRAX (see What are the ingredients in LIBRAX?)
- you have severe lung or breathing problems
- you have a mental health disorder (psychosis)
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take LIBRAX. Talk about any health conditions or problems you may have, including if you:
- have open-angle glaucoma
- have high blood pressure
- have an overactive thyroid (hyperthyroidism)
- have depression or psychosis
- have a type of lung disease called chronic obstructive pulmonary disease (COPD)
- have any kidney problems
- have memory problems
- have impaired thinking, confusion or any other type of brain damage
- have dry mouth
- are allergic to any other benzodiazepines or anticholinergic medications
- are taking pain killers, known as opioids
have ever had a problem with:
- substance use, including prescribed or illegal drugs, or
- alcohol
- have ever had seizures or convulsions (violent uncontrollable shaking of the body with or without loss of consciousness)
- live or work in a high temperature environment
- are sensitive to drugs known as benzodiazepines, atropine or belladonna
- are 65 years of age, or older
- are pregnant, think you may be pregnant or are planning to become pregnant, LIBRAX may harm your baby
- are breastfeeding, LIBRAX may harm your baby
Other warnings you should know about:
Pregnancy and Breastfeeding: Benzodiazepines such as LIBRAX may harm your unborn baby (e.g. birth defects) if you take them while you are pregnant. The risk is higher if you take LIBRAX during the first trimester of pregnancy, just before labour, or during labour. If you are able to get pregnant, want to be pregnant, or think you are pregnant, there are specific risks you should discuss with your healthcare professional. LIBRAX may stop lactation and/or cause unwanted side effects to your baby if you take it while breastfeeding.
Withdrawal: If you suddenly stop your treatment, lower your dose too fast, or switch to another medication, you can experience withdrawal symptoms that can range from mild symptoms to severe or life threatening. Some of your withdrawal symptoms can last for months after you stop LIBRAX.
Your risk of going through withdrawal is higher if you are taking LIBRAX for a long time or at high doses. However, symptoms can still occur if you are taking LIBRAX as directed for a short period of time or slowly reducing the dose.
The symptoms of withdrawal often resemble the condition that you are being treated for. After stopping your treatment, it may be hard to tell if you are experiencing withdrawal or a return of your condition
(relapse).
Tell your doctor right away if you experience any symptoms of withdrawal after changing or stopping your treatment.
Severe symptoms of withdrawal include:
- feeling like you cannot move or respond (catatonia)
- severe confusion, shivering, irregular heartrate and excessive sweating (delirium tremens)
- feeling depressed
- feeling disconnected from reality (dissociation)
- seeing or hearing things that are not there (hallucinations)
- overactive behavior and thoughts (mania)
- believing in things that are not true (psychosis)
- convulsions (seizures), including some that do not stop
- thoughts or actions of suicide
For other symptoms of withdrawal, see the Serious side effects and what to do about them table (below).
To reduce your chances of going through withdrawal:
- always contact your doctor before stopping or reducing your dose of LIBRAX or changing medications
- always follow your doctor’s instructions on how to reduce your dose carefully and safely
- tell your doctor right away if you experience any unusual symptoms after changing or stopping your treatment
LIBRAX with Opioids: Taking LIBRAX with opioid medicines can cause severe drowsiness and breathing problems.
Tell your doctor if you:
- are taking opioid medicines
- are prescribed an opioid medicine after you start taking LIBRAX
Do NOT drive or operate heavy machinery or do tasks that require special attention until you know how taking an opioid medicine and LIBRAX affects you.
Falls and Fractures: Benzodiazepines like LIBRAX can cause you to feel sleepy, dizzy and affect your balance. This increases your risks of falling, which can cause fractures or other fall related-injuries, especially if you:
- take other sedatives
- consume alcohol
- are elderly or
- have a condition that causes weakness or frailty
Dental Problems: If you use LIBRAX for a long time, it may cause you to produce less saliva or it might stop your saliva production. This may cause dental problems such as cavities, swollen gums or gingivitis, oral thrush and/or discomfort.
Monitoring and Tests: During your treatment with LIBRAX, your healthcare professional may do tests to monitor your blood cell count and your liver function.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious Drug Interactions Taking LIBRAX and opioids may cause:
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The following may also interact with LIBRAX:
- Alcohol
- Sedative antihistamines
- Medications used to treat epilepsy (anticonvulsants)
- Medications used to manage psychosis (antipsychotics)
- Medications used to treat depression (antidepressants)
- Medications that affect your mind, emotions, or behaviour (psychotropics)
- Cimetidine, a medicine used to treat heartburn and stomach ulcers
- Erythromycin, a medicine used to treat bacterial infections
- Ketoconazole or itraconazole, which are medicines used to treat fungal infections
- Nefazodone, a medicine used to treat depression
- Certain medicines used to treat HIV/AIDS
How to take LIBRAX:
- Take LIBRAX exactly as your healthcare professional tells you to take it
Take LIBRAX before meals
Usual dose:
Adults (18 to 64 years of age): 1 or 2 capsules one to four times a day, 30 to 60 minutes before meals or food. The maximum dose is 8 capsules per day.
Elderly (65 years of age and older): The starting dose is no more than 1 capsule two times a day.
Your doctor will slowly decrease your dose and will tell you when to stop taking this medication. Always follow your doctor’s instructions on how to lower your dose carefully and safely to avoid experiencing withdrawal symptoms.
Overdose:
| If you think you, or a person you are caring for, have taken too much LIBRAX, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
If you forget to take LIBRAX capsules at the correct time, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue to take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
What are possible side effects from using LIBRAX?
These are not all the possible side effects you may have when taking LIBRAX. If you experience any side effects not listed here, tell your healthcare professional.
- Headache
- Dizziness
- Drowsiness
- Unusual tiredness or weakness
- Blurred vision
- Dry mouth
- Feeling bloated
- Stomach or muscle cramps
- Constipation
- Nausea
- Skin rash or hives
- Decreased sweating
- Decreased sexual ability; changes in sexual desire
- Menstrual irregularities
- Falls and fractures
SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM
| Symptom/effect | Talk to your Healthcare Professional | Stop taking drug and seek immediate medical help | |
| Only if severe | In all cases | ||
| LESS COMMON | |||
| Confusion, memory loss | ✓ | ||
| RARE | |||
| Agranulocytosis (severe reduction in white blood cell count): fever, chills, low blood pressure | ✓ | ||
| Depression: Depressed mood; thoughts of death or suicide | ✓ | ||
| Mental and behavioural changes: Unexpected reactions such as agitation, anxiety, hyperactivity, excitement, hallucination, impaired concentration or memory, worsened insomnia, feeling nervous, irritable, increased muscle spasticity, aggressiveness, irritability, rages, psychoses and violent behavior | ✓ | ||
| Movement problems: ataxia (including unsteadiness and clumsiness), trembling (extrapyramidal symptoms) | ✓ | ||
| Severe allergic reaction: skin reactions (skin eruptions, rash, hives), swelling including of the tongue or throat, trouble breathing, nausea and vomiting | ✓ | ||
| Syncope (fainting): a temporary loss of consciousness due to a sudden drop in blood pressure | ✓ | ||
| UNKNOWN FREQUENCY | |||
| Blurred of vision, eye pain | |||
| Hepatic dysfunction (liver function abnormalities): jaundice (yellowing of the skin and eyes), dark urine, light coloured stool, itching all over your body | |||
| Oedema: swelling of hands, ankles or feet | |||
| Overdose: extreme sleepiness, confusion, slurred speech, slow reflexes, slow shallow breathing, coma, loss of balance and coordination, uncontrolled rolling of the eyes, and low blood pressure. | ✓ | ||
| Respiratory Depression: slow, shallow or weak breathing. | ✓ | ||
| Seizures (fits): uncontrollable shaking with or without loss of consciousness | ✓ | ||
| Somnambulism (sleepwalking): getting out of bed while not fully awake and do activities you do not remember the day after, or sleep driving | |||
| Urinary hesitancy: trouble starting or maintaining urine flow |
Withdrawal: Severe symptoms include: Catatonia: feeling like you cannot move or respond Delirium Tremens: severe confusion, shivering, irregular heartrate and excessive sweating Feeling depressed Dissociation: feeling disconnected from reality Hallucinations: seeing or hearing things that are not there Mania: overactive behaviour and thoughts Psychosis: believing in things that are not true Convulsions: (seizures – including some that do not stop): loss of consciousness with uncontrollable shaking Thoughts or actions of suicide Other symptoms include: Stomach cramps; trouble remembering or concentrating; diarrhea; feeling uneasy or restless; severe anxiety or panic-attacks; headache; sensitivity to light, noise or physical contact; shaking; vomiting; trouble sleeping; feeling irritable; muscle pain or stiffness; a burning or prickling feeling in the hands, arms, legs or feet; sweating. | ✓ |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store at room temperature (15oC to 30oC)
Keep out of reach and sight of children.
If you want more information about LIBRAX:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html, or by calling 1-800-361-4261.