Active ingredients: Chlordiazepoxide, Clidinium bromide
Librax 5 mg + 2.5 mg coated tablets
Why is Librax used? What is it for?
Pharmacotherapeutic group
Librax belongs to the therapeutic category of associated antispasmodics.
Indications
Spastic-painful manifestations, with an anxious component, of the gastro-enteric system. Benzodiazepines are indicated in states of anxiety only when the disorder is severe, disabling or subjects the subject to severe discomfort.
Contraindications When Librax should not be used
- Hypersensitivity to the active substances or to any of the excipients.
- Closed-angle glaucoma.
- Prostatic hypertrophy or other causes of obstructive uropathy.
- Paralytic ileus and obstructive pathologies of the gastrointestinal system.
- Urinary retention syndromes.
- Ulcerative colitis and toxic megacolon.
- Patients with polypathologies over the age of 65
- Patients over the age of 75.
- Children and adolescents under 18 years of age.
- Myasthenia gravis.
- Severe respiratory insufficiency.
- Severe hepatic insufficiency, acute or chronic (risk of developing encephalopathy).
- Sleep apnea syndrome.
- Pregnancy and breastfeeding (see Pregnancy and breastfeeding)
Precautions for use What you need to know before taking Librax
Prolonged use
When the product is taken for long periods of time, periodically monitor the trend of blood pressure values and the state of hepatic and renal function.
Tolerance
Some loss of efficacy to the hypnotic effects of benzodiazepines may develop after repeated use for a few weeks.
Interactions Which drugs or foods may change the effect of Librax
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Concomitant alcohol intake should be avoided. The sedative effect may be enhanced when the drug is taken in conjunction with alcohol.
This adversely affects the ability to drive or use machines.
When combined with drugs with CNS depressant activity, such as antipsychotics (neuroleptics), hypnotics, anxiolytics / sedatives, antidepressants, narcotic analgesics, antiepileptics, anesthetics and sedative antihistamines, chlordiazepoxide can reinforce their action. increased euphoria leading to an increase in psychic and physical dependence. Co-administration of Librax with medicinal products that affect CYP3A4 causes changes in plasma concentrations of lordiazepoxide. To a lesser extent, this also applies to benzodiazepines which are metabolized only by conjugation.
The effects of preparations containing anticholinergics are accentuated by the simultaneous administration of substances belonging to different therapeutic groups but with anticholinergic action such as antihistamines, butyrophenones, phenothiazines, tricyclic antidepressants and amantadine, which therefore must not be taken at the same time.
Warnings It is important to know that:
Dependence
The use of benzodiazepines can lead to the development of physical and mental dependence on these drugs. Dependence can occur at therapeutic doses and / or in patients with no distinct risk factors. The risk of addiction increases with dose and duration of treatment. it is greater in patients with a history of drug or alcohol abuse.
Once the physical dependence has developed, the abrupt termination of treatment will be accompanied by withdrawal symptoms. These can consist of insomnia, headache, muscle aches, muscle tension, hyperreactivity, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases the following symptoms may occur: derealization, depersonalization, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or seizures.
Discontinuation symptoms may occur in the days following discontinuation of treatment. The combination of several benzodiazepines, whatever the indication (anxiolytic or hypnotic), increases the risk of drug dependence.
Rebound insomnia and anxiety
Upon discontinuation of treatment, a transient syndrome may occur in which the symptoms that led to treatment with benzodiazepines recur in an aggravated form. It may be accompanied by other reactions, including mood changes, anxiety, restlessness, or sleep disturbances.
Since the risk of withdrawal or rebound symptoms is greater after abrupt discontinuation of treatment, a gradual decrease in dosage is suggested.
Duration of treatment
The duration of treatment should be as short as possible but should not exceed 8-12 weeks, including a gradual withdrawal period.
Extension beyond these periods should not occur without a reassessment of the patient's condition.
When using benzodiazepines with a long duration of action, it is important to warn the patient that sudden change to a short-acting benzodiazepine is not recommended, as withdrawal symptoms may occur. It may be helpful to inform the patient when treatment is started. , that it will be of limited duration and explain precisely how the dosage should be progressively decreased. It is also important that the patient is informed of the possibility of rebound phenomena, thus minimizing anxiety about these symptoms should they occur upon discontinuation of the drug.
Amnesia and impaired psychomotor function
Benzodiazepines can induce anterograde amnesia and alterations in psychomotor functions. This happens most often several hours after ingestion of the drug and, therefore, to reduce the risk it should be ensured that patients can have an uninterrupted sleep of 7-8 hours (see side effects).
Psychiatric and paradoxical reactions
When benzodiazepines and similar products are used, it is known that in some subjects, they can give rise to a combination of alterations affecting the state of consciousness, behavior and memory problems.
The following reactions can occur:
- aggravation of insomnia, nightmares, agitation, nervousness
- delusional thoughts, hallucinations, confusional-dream state, psychotic symptoms
- loss of inhibitions with impulsivity
- euphoria, irritability
- anterograde amnesia
- suggestibility.
This syndrome can be accompanied by potentially dangerous problems for the patient or others such as:
- unusual behavior for the patient
- self- or hetero-aggressive behaviors, particularly if friends and relatives try to obstruct the patient's activity
- automatic behavior with post-event amnesia
Should this occur during treatment with Librax, its administration should be discontinued. Such reactions are more frequent in the elderly. Particular precaution should be taken when prescribing benzodiazepines to patients with personality disorders.
Specific patient groups and risk of accumulation
Since chlordiazepoxide is a long-acting benzodiazepine, patients should be regularly monitored to decrease the dose or frequency of administration if necessary to prevent overdose due to accumulation.
In elderly people or in patients with hepatic and / or renal insufficiency the half-life of benzodiazepines may be significantly extended. Dose adjustment may be required (see Dose, method and time of administration).
Benzodiazepines and similar products should be used with caution in elderly subjects due to the risk of sedation and / or muscle relaxant effect, which could lead to falls with consequences that are often severe in this population.
In people with major depressive episodes, benzodiazepines and similar products should not be prescribed alone, as they can lead to depression with persistent or increased risk of suicide.
Precautions for use (associated with chlordiazepoxide)
It may be useful to inform the patient that the treatment will be of limited duration and to explain precisely how the dosage will be progressively decreased. Furthermore, it is important that the patient is informed of the possibility of rebound phenomena, in order to minimize the patient's anxiety if these symptoms occur during the interruption of treatment.
In the case of respiratory insufficiency, the depressive effect of benzodiazepines and similar products must be taken into account (since anxiety and agitation can be indicative of decompensated respiratory function, which justifies admission to intensive care).
Precautions for use (associated with clidinium bromide)
Use with caution in case of:
- prostate hypertrophy,
- kidney or liver failure,
- coronary insufficiency, heart rate problems, hyperthyroidism,
- chronic bronchitis due to an increase in the viscosity of bronchial secretions.
Alcohol and drug abuse
Patients under the influence of the drug, as well as any other psychotropic drug, should refrain from alcoholic beverages, as individual reactions are unpredictable.Benzodiazepines should be used with extreme caution in patients with a history of drug and alcohol abuse or drug dependence (see Interactions).
Fertility, pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Do not administer in the first and last trimester of pregnancy and during lactation.
Fertility
If Librax is prescribed to a woman of childbearing age, she should be advised that, whether she intends to become pregnant or suspects that she is pregnant, she should contact her doctor to consider stopping treatment.
Pregnancy
There are no adequate clinical data on the use of Librax in pregnant women or animal tests showing that the drug is safe.
Therefore do not administer during pregnancy, especially during the first and last trimester, unless there are reasons of real need and under the direct supervision of the doctor.
If, for serious medical reasons, the product is administered during the last period of pregnancy or during labor at high doses, effects on the newborn may occur, such as hypothermia, hypotonia and moderate respiratory depression due to the pharmacological action of the drug. Additionally, infants born to mothers who have chronically taken benzodiazepines during late pregnancy may develop physical dependence and may be at some risk of developing withdrawal symptoms in the postnatal period.
Given the presence of clinidinium, Librax should be administered with caution at the end of pregnancy due to the risk of atropine effects in the child (meconium ileus).
Feeding time
Since benzodiazepines (chlordiazepoxide) are excreted in breast milk, they should not be given to breastfeeding mothers. If it is necessary to continue the therapy, it is preferable to suspend breastfeeding.
Clidinium can decrease milk secretion and pass into breast milk causing atropine effects in the baby.
Effects on ability to drive and use machines
Librax impairs the ability to drive and use machines and there may be a risk of drowsiness during therapy. Sedation, amnesia, difficulty concentrating and impaired muscle function may adversely affect the ability to drive or use machines. Combination with other sedative medicines is not recommended; be aware of this when driving vehicles or operating machines (see Interactions). If sleep duration has been insufficient, the likelihood of impaired alertness may be increased.
Important information about some of the excipients
Librax contains lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Librax contains beta-carotene. In patients who smoke twenty or more cigarettes a day, prolonged use of the product may increase the risk of developing lung cancer.
Dosage and method of use How to use Librax: Dosage
Depending on the severity of the case, 1-2 Librax coated tablets are administered 2 to 4 times a day: Librax should be taken preferably with main meals and before bedtime or when pain occurs.
It is always advisable to start treatment with the minimum dose indicated, subsequently increasing it, if necessary, after testing the individual reactivity; the maximum dose should not be exceeded. The duration of treatment should be as short as possible. The patient's condition should be re-evaluated on a regular basis to determine whether treatment should be continued, particularly in the absence of symptoms. The overall duration of treatment should generally not exceed 8-12 weeks, including a gradual withdrawal period (see special warnings). In certain cases, extension beyond the maximum treatment period may be necessary; in this case, such extension of treatment should not occur without reassessment of the patient's condition.
Since chlordiazepoxide is a long-acting benzodiazepine, the patient should be monitored regularly to decrease, if necessary, the dose or frequency of administration in order to prevent overdose due to accumulation.
Pediatric population
Librax should not be used in children and adolescents under 18 years of age. The safety and efficacy in children and adolescents has not yet been established.
Special populations
In the treatment of elderly patients (aged over 65 years but not over 75 years old and in the absence of multiple pathologies) and / or debilitated, patients with organic brain damage, respiratory insufficiency and / or renal or hepatic dysfunction should not be exceeded half of the doses indicated above.
Method of administration
Oral use. Swallow with some liquid.
Overdose What to do if you have taken too much Librax
Associated with chlordiazepoxide
Clinical signs and symptoms:
As with other benzodiazepines, an overdose can be life threatening, particularly in cases of polytoxication involving other central nervous system depressants (including alcohol).
In the treatment of overdose of any drug, the possibility that other substances have been taken at the same time should be considered.
Benzodiazepine overdose usually presents with varying degrees of central nervous system depression ranging from clouding to coma. In mild cases, symptoms include drowsiness, confusion, and lethargy. In severe cases, symptoms may include ataxia, hypotonia, hypotension , respiratory depression, rarely coma and, very rarely, death.
Treatment:
In the event of an oral benzodiazepine overdose, vomiting should be induced (within one "hour) if the patient is conscious or gastric lavage with airway protection performed if the patient is unconscious. of the stomach should not bring any benefit, administer activated charcoal to reduce absorption. Particular attention must be paid to respiratory and cardiovascular functions in intensive care.
The therapy, in addition to the usual measures to support vital functions, consists in the administration of the specific benzodiazepine antagonist, flumazenil, and parasympathomimetics, eg physostigmine or neostigmine 0.5-2.5 mg intravenously or intramuscularly. The administration of flumazenil it may be useful in the diagnosis and / or treatment of intentional or accidental overdose with benzodiazepines. Flumazenil's antagonism of the effect of benzodiazepines may favor the onset of neurological problems (seizures), particularly in epileptic patients. from glaucoma, locally administer pilocarpine.
Associated with clidinium bromide
Clinical signs and symptoms:
Anticholinergic effects such as urinary retention, dry mouth, tachycardia, mild numbness and transient visual disturbances (including mydriasis, accommodation paralysis), redness of the skin, inhibition of gastrointestinal motility, and disturbances may occur in the event of clidinium bromide overdose. more serious such as circulatory and respiratory changes, tachycardia, state of excitement, agitation, confusion and hallucination, delirium, respiratory depression and coma.
Treatment:
Treatment of clidinium bromide overdose is symptomatic and includes cardiac and respiratory monitoring in a hospital setting.
Catheterization may be required for urinary retention. If necessary, appropriate supportive care should be undertaken.
If you accidentally take an excessive dose of Librax, notify your doctor immediately or go to the nearest hospital.
If you have any questions about the use of Librax, ask your doctor or pharmacist.
Side Effects What are the side effects of Librax
Like all medicines, Librax can cause side effects, although not everybody gets them.
The most common side effects include sedation, dizziness, somnolence, ataxia, fatigue and balance disturbances. These effects are dose-related and may persist for days following treatment, even after a single dose.
However, these effects occur mainly at the beginning of therapy and normally disappear with subsequent administrations.
The elderly are particularly sensitive to the effects of centrally depressant medications, whereby episodes of confusion may occur, especially if organic brain changes are present.
The evaluation of undesirable effects is based on the following frequencies:
- Very common (≥ 1/10)
- Common (≥ 1/100,
- Uncommon (≥ 1 / 1,000 to
- Rare (≥ 1 / 10,000,
- Very rare (
- Not known (frequency cannot be estimated from the available data).
Amnesia
Anterograde amnesia can also occur at therapeutic dosages of benzodiazepines, the risk increases at higher dosages. Amnesic effects may be associated with behavioral changes (see Special warnings).
Depression
During the use of benzodiazepines a pre-existing depressive state can be unmasked. Benzodiazepines can cause reactions such as: restlessness, agitation, irritability, aggression, disappointment, anger, nightmares, hallucinations, psychosis, behavioral changes. These reactions can be quite severe. They are more likely in the elderly.
Dependence
The use of benzodiazepines, even at therapeutic doses, can lead to the development of physical dependence: discontinuation of therapy can cause rebound or withdrawal phenomena (see Special warnings). Psychic dependence may occur.
Abuse of benzodiazepines has been reported.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the website http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Expiry: see the expiry date indicated on the package.
The expiry date refers to the product in intact and correctly stored packaging.
Warning: do not use the medicine after the expiry date indicated on the package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Keep this medicine out of the sight and reach of children.
Deadline "> Other information
Composition
One coated tablet contains:
- Active ingredients: chlordiazepoxide 5 mg + clidinium bromide 2.5 mg.
- Excipients: lactose; talc; starch (from corn, rice, potato); Arabic gum; magnesium stearate; E141; E160a, liquid paraffin; solid paraffin; sucrose.
Box of 20 coated tablets, in blister.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
LIBRAX 5 MG + 2.5 MG COATED TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
One coated tablet contains:
Active principles:
chlordiazepoxide 5 mg;
clidinium bromide 2.5 mg.
Excipients with known effects: lactose, sucrose.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM -
Coated tablet for oral use.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Spastic-painful manifestations, with an anxious component, of the gastro-enteric system.
Benzodiazepines are indicated in states of anxiety only when the disorder is severe, disabling or subjecting the subject to severe discomfort.
04.2 Posology and method of administration -
Depending on the severity of the case, 1-2 Librax coated tablets are administered 2 to 4 times a day: Librax should be taken preferably with main meals, before going to bed or at the onset of pain.
It is always advisable to start treatment with the minimum dose indicated, subsequently increasing it, if necessary, after testing the individual reactivity; the maximum dose should not be exceeded.
Treatment should be as short as possible. The patient's condition should be re-evaluated on a regular basis to determine whether treatment should be continued, particularly in the absence of symptoms. The overall duration of treatment should generally not exceed 8-12 weeks, including a gradual withdrawal period (see section 4.4). In certain cases, extension beyond the maximum treatment period may be necessary; in this case, such extension of treatment should not occur without reassessment of the patient's condition.
Since chlordiazepoxide is a long-acting benzodiazepine, the patient should be monitored regularly to decrease the dose or frequency of Librax intake if necessary to prevent benzodiazepine overdose due to accumulation.
Pediatric population
Librax should not be used in children and adolescents under 18 years of age. The safety and efficacy in children and adolescents has not yet been established.
Special populations
In the treatment of elderly patients (aged over 65 years but not over 75 years old and in the absence of multiple pathologies) and / or debilitated patients, patients with organic brain damage, respiratory insufficiency and / or renal or hepatic dysfunction should not be exceeded half of the above doses.
Method of administration
• Oral use. Swallow with some liquid.
04.3 Contraindications -
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Librax is contraindicated in patients with:
• Risk of narrow-angle glaucoma
• prostatic hypertrophy or other causes of obstructive uropathy
• paralytic ileus and obstructive pathologies of the gastrointestinal system
• urinary retention syndromes
• Ulcerative colitis
• toxic megacolon
• patients with polypathologies over the age of 65
• children and adolescents under 18 years of age
• myasthenia gravis
• severe respiratory failure
• severe acute or chronic liver failure (risk of developing encephalopathy)
• sleep apnea syndrome
• pregnancy and lactation (see section 4.6).
04.4 Special warnings and appropriate precautions for use -
This medicinal product contains a benzodiazepine and an atropine antispasmodic.
Being a combination, if taken with other drugs with similar action, the undesirable effects can synergize and multiply, in particular the sedative and atropinic effects (see section 4.5).
Prolonged use
When the product is taken for long periods of time, periodically monitor the progress of blood pressure, blood crasis and the state of hepatic and renal function.
Tolerance
Some loss of efficacy to the hypnotic effects of benzodiazepines may develop after repeated use for a few weeks.
Dependence
The use of benzodiazepines can lead to the development of physical and psychological dependence on these drugs. The risk of dependence increases with dose and duration of treatment, and is greater in patients with a history of drug or alcohol abuse.
Once the physical dependence has developed, the abrupt termination of treatment will be accompanied by withdrawal symptoms. These can consist of headache, body aches, extreme anxiety, tension, restlessness, confusion and irritability.
In severe cases the following symptoms may occur: derealization, depersonalization, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or seizures. Discontinuation symptoms may occur in the days following discontinuation of treatment. The combination of several benzodiazepines, whatever the indication (anxiolytic or hypnotic), increases the risk of drug dependence.
Rebound insomnia and anxiety
Upon discontinuation of treatment, a transient syndrome may occur in which the symptoms that led to treatment with benzodiazepines recur in an aggravated form. It may be accompanied by other reactions, including mood changes, anxiety, restlessness, or sleep disturbances.
Since the risk of withdrawal or rebound symptoms is greater after abrupt discontinuation of treatment, a gradual decrease in dosage is suggested.
Duration of treatment
The duration of treatment should be as short as possible but should not exceed 8-12 weeks, including a gradual withdrawal period.
Extension beyond these periods should not occur without reassessment of the patient's condition. When using benzodiazepines with a long duration of action, it is important to warn the patient that sudden change to a short-acting benzodiazepine is inadvisable. as withdrawal symptoms may occur.
It may be useful to inform the patient, when treatment begins, that it will be of limited duration and to explain precisely how the dosage should be progressively decreased.
It is also important that the patient is informed of the possibility of rebound phenomena, thus minimizing the anxiety about these symptoms should they occur when the drug is discontinued.
Amnesia and impaired psychomotor function
Benzodiazepines can induce anterograde amnesia and alterations in psychomotor functions. This occurs most often several hours after ingestion of the drug and, therefore, to reduce the risk it should be ensured that patients can have an uninterrupted sleep of 7-8 hours (see section 4.8 Undesirable effects).
Psychiatric and paradoxical reactions
When benzodiazepines and similar products are used, it is known that in some subjects they can give rise to a combination of alterations affecting the state of consciousness, behavior and memory problems.
The following reactions can occur:
• worsening of insomnia, nightmares, agitation, nervousness
• delusional thoughts, hallucinations, confusional-dream state, psychotic symptoms
• loss of inhibitions with impulsiveness
• euphoria, irritability
• antegrade amnesia
• suggestibility.
This syndrome can be accompanied by potentially dangerous problems for the patient or others such as:
• unusual behavior for the patient
• self- or hetero-aggressive behaviors, particularly if friends and relatives try to obstruct the patient's activity
• automatic behavior with post-event amnesia
Should this occur during treatment with Librax, its administration should be discontinued. Such reactions are more frequent in the elderly. Particular precaution should be taken when prescribing benzodiazepines to patients with personality disorders.
Specific patient groups and risk of accumulation
Since chlordiazepoxide is a long-acting benzodiazepine, patients should be regularly monitored to decrease the dose or frequency of administration if necessary to prevent overdose due to accumulation.
In elderly people or in patients with hepatic and / or renal insufficiency the half-life of benzodiazepines may be significantly extended. Dose adjustment may be required (see section 4.2).
Benzodiazepines and similar products should be used with caution in elderly subjects due to the risk of sedation and / or muscle relaxant effect, which could lead to falls with consequences that are often severe in this population.
In people with major depressive episodes, benzodiazepines and similar products should not be prescribed alone, as they can lead to depression with persistent or increased risk of suicide.
Precautions for use (associated with chlordiazepoxide)
It may be useful to inform the patient that the treatment will be of limited duration and to explain precisely how the dosage will be progressively decreased. Furthermore, it is important that the patient is informed of the possibility of rebound phenomena, in order to minimize the patient's anxiety if these symptoms occur during the interruption of treatment.
In the case of respiratory insufficiency, the depressive effect of benzodiazepines and similar products must be taken into account (since anxiety and agitation can be indicative of decompensated respiratory function, which justifies admission to intensive care).
Precautions for use (associated with clidinium bromide)
Use with caution in case of:
• hypertrophy of the prostate,
• kidney or liver failure,
• coronary insufficiency, heart rate problems, hyperthyroidism,
• chronic bronchitis due to an increase in the viscosity of bronchial secretions.
Alcohol and drug abuse
Patients under the influence of the drug, as well as any other psychotropic drug, should refrain from alcoholic beverages, as individual reactions are unpredictable. Benzodiazepines should be used with extreme caution in patients with a history of drug and alcohol abuse or drug dependence (see section 4.5).
Important information about some of the excipients
Librax contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Librax contains sucrose. Patients with rare hereditary problems of fructose intolerance, sucrase isomaltase insufficiency, or glucose-galactose malabsorption should not take this medicine.
Due to the presence of beta-carotene in the composition, prolonged use of the product may increase the risk of lung cancer in heavy smokers (twenty or more cigarettes a day).
04.5 Interactions with other medicinal products and other forms of interaction -
Concomitant alcohol intake should be avoided. The sedative effect may be enhanced when the drug is taken in conjunction with alcohol. This adversely affects the ability to drive or use machines.
Interactions with chlordiazepoxide
Interactions with clidinium bromide
04.6 Pregnancy and breastfeeding -
Do not administer in the first and last trimester of pregnancy and during lactation.
Fertility
If Librax is prescribed to a woman of childbearing potential, she should be advised that, whether she intends to become pregnant or suspects that she is pregnant, she should contact her doctor to consider stopping treatment.
Pregnancy
There are no adequate clinical data on the use of Librax in pregnant women or animal tests showing that the drug is safe.
Therefore do not administer during pregnancy, especially during the first and last trimester, unless there are reasons of real need and under the direct supervision of the doctor.
If, for serious medical reasons, the product is administered during the last period of pregnancy or during labor at high doses, effects on the newborn may occur, such as hypothermia, hypotonia and moderate respiratory depression due to the pharmacological action of the drug.
Additionally, infants born to mothers who have chronically taken benzodiazepines during late pregnancy may develop physical dependence and may be at some risk of developing withdrawal symptoms in the postnatal period.
Given the presence of clinidinium, Librax should be administered with caution at the end of pregnancy due to the risk of atropine effects in the child (meconium ileus).
Feeding time
Since benzodiazepines (chlordiazepoxide) are excreted in breast milk, they should not be given to breastfeeding mothers. If it is necessary to continue the therapy, it is preferable to suspend breastfeeding.
Clidinium can decrease milk secretion and pass into breast milk causing atropine effects in the baby.
04.7 Effects on ability to drive and use machines -
Librax impairs the ability to drive and use machines.
Inform drivers of vehicles and machinery of the possible risk of drowsiness.
Sedation, amnesia, difficulty concentrating and impaired muscle function may adversely affect the ability to drive or use machines. Combination with other sedative medicinal products is not recommended; be aware of this when driving vehicles or operating machines (see section 4.5). If sleep duration has been insufficient, the likelihood of impaired alertness may be increased.
04.8 Undesirable effects -
The most common side effects include sedation, dizziness, somnolence, ataxia, fatigue and balance disturbances. These effects are dose-related and may persist for days following treatment, even after a single dose.
However, these effects occur mainly at the beginning of therapy and normally disappear with subsequent administrations.
The elderly are particularly sensitive to the effects of centrally depressant medications, whereby episodes of confusion may occur, especially if organic brain changes are present.
The evaluation of undesirable effects is based on the following frequencies:
Very common (≥ 1/10)
Common (≥ 1/100,
Uncommon (≥ 1 / 1,000 to
Rare (≥ 1 / 10,000,
Very rare (
Not known (frequency cannot be estimated from the available data).
Amnesia
Anterograde amnesia can also occur at therapeutic dosages of benzodiazepines, the risk increases at higher dosages. Amnesic effects may be associated with behavioral changes (see section 4.4 Special warnings and precautions for use).
Depression
During the use of benzodiazepines a pre-existing depressive state can be unmasked. Benzodiazepines can cause reactions such as: restlessness, agitation, irritability, aggression, disappointment, anger, nightmares, hallucinations, psychosis, behavioral changes. These reactions can be quite severe. They are more likely in the elderly.
Dependence
The use of benzodiazepines, even at therapeutic doses, can lead to the development of physical dependence: discontinuation of therapy can cause rebound or withdrawal phenomena (see section 4.4 Special warnings and precautions for use). Psychic dependence may occur.
Abuse of benzodiazepines has been reported.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose -
Associated with chlordiazepoxide
Clinical Signs and Symptoms: As with other benzodiazepines, overdose can be life threatening, particularly in cases of polytoxication involving other central nervous system depressants (including alcohol).
In the treatment of overdose of any drug, the possibility that other substances have been taken at the same time should be considered.
Benzodiazepine overdose usually presents with varying degrees of central nervous system depression ranging from clouding to coma. In mild cases, symptoms include drowsiness, confusion, and lethargy. In severe cases, symptoms may include ataxia, hypotonia, hypotension , respiratory depression, rarely coma and, very rarely, death.
Treatment
In the event of an oral benzodiazepine overdose, vomiting should be induced (within one "hour) if the patient is conscious or gastric lavage with airway protection performed if the patient is unconscious. of the stomach should not bring any benefit, administer activated charcoal to reduce absorption. Particular attention must be paid to respiratory and cardiovascular functions in intensive care.
The therapy, in addition to the usual measures to support vital functions, consists in the administration of the specific benzodiazepine antagonist, flumazenil, and parasympathomimetics, eg physostigmine or neostigmine 0.5-2.5 mg intravenously or intramuscularly. The administration of flumazenil may be useful in the diagnosis and / or treatment of intentional or accidental overdose with benzodiazepines.
The antagonism of the effect of benzodiazepines by flumazenil may favor the onset of neurological problems (convulsions), particularly in epileptic patients. In glaucoma patients, pilocarpine is administered locally.
Associated with clidinium bromide
Clinical signs and symptoms:
Anticholinergic effects such as urinary retention, dry mouth, tachycardia, mild numbness and transient visual disturbances (including mydriasis, accommodation paralysis), redness of the skin, inhibition of gastrointestinal motility, and disturbances may occur in the event of clidinium bromide overdose. more serious such as circulatory and respiratory changes, tachycardia, state of excitement, agitation, confusion and hallucination, delirium, respiratory depression and coma.
Treatment:
Treatment of clidinium bromide overdose is symptomatic and includes cardiac and respiratory monitoring in a hospital setting.
Catheterization may be required for urinary retention. If necessary, appropriate supportive care should be undertaken.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: synthetic anticholinergics in combination with psycholeptics.
ATC code A03CA02.
Chlordiazepoxide is an anxiolytic belonging to the benzodiazepine class.
Pharmacologically its properties are those of the benzodiazepine class: anxiolytic, sedative, hypnotic, anticonvulsant, muscle relaxant and amnesic. These effects are associated with a specific agonist action at the level of central receptors belonging to the macromolecular receptor complex GABA-OMEGA (also known as BZ1 and BZ2) which modulates the opening of the chlorine channel. Addiction has been observed in animals and humans. from the drug.
Clidinium Bromide is a synthetic anticholinergic that has a spasmolytic effect on smooth muscle and inhibits secretions.
The composition of Librax aims to combine the central effects of a psychotropic drug such as chlordiazepoxide with the peripheral anticholinergic effects of clidinium bromide. The anxiolytic effect and the emotional control exerted by chlordiazepoxide find a valid complement in the peripheral spasmolytic action of clidinium bromide intended to locally regulate visceral function.
05.2 "Pharmacokinetic properties -
Absorption
After oral administration, chlordiazepoxide is almost completely absorbed and reaches the plasma largely unchanged.
Peak plasma levels are typically reached within 1-2 hours of administration. The half-life of chlordiazepoxide is 6-30 hours. Steady state plasma concentrations are usually achieved within 3 days.
Distribution
In equilibrium conditions the volume of distribution of chlordiazepoxide is 0.3-0.4 l / kg. The plasma protein binding is 93-97%.
Benziodiazepines pass the placental barrier and are excreted in breast milk.
Metabolism
Chlordiazepoxide is metabolised in the liver into demethylchlordiazepoxide (0.64%), demoxepam (0.32%) and demethyldiazepam (0.21%); demoxepam is transformed into an active metabolite, oxazepam, but in a very small proportion (less than 1% of ingested chlordiazepoxide).
Steady state concentrations of these metabolites are reached after 10-15 days and are similar to those of chlordiazepoxide.
Clidinium bromide is metabolised to methyl-1-hydroxy-3 quinoclidinium bromide which is the major metabolite found in human urine. Carbon-labeled studies show that the substance is not metabolized by N-demethylation.
Elimination
The urinary elimination of chlordiazepoxide occurs in the form of demozepam and oxazepam. The elimination half-life is 7-28 hours (usually 20-24 hours). Clidinium bromide and its metabolites are found in faeces, dogs and humans.
05.3 Preclinical safety data -
Mutagenic and carcinogenic potential
In-vivo and in-vitro studies with chlordiazepoxide showed a mutagenic effect.
However, negative results were obtained in similar test systems. The relevance of the positive results is currently unclear. Carcinogenicity studies showed a higher incidence of liver tumors in mice treated with high doses, mainly in male animals, while such an increase in the incidence rate of tumors was not observed in the rat.
Reproductive toxicity
So far, available observations in humans have not shown any clear evidence of a teratogenic effect of chlordiazepoxide; however, changes in the urogenital tract, pulmonary abnormalities and skull malformations (exencephaly, cleft palate) have been observed in animal studies. behavioral disorders affecting the offspring.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
One coated tablet contains:
Excipients:
lactose; talc; starch (from corn, rice, potato); Arabic gum; magnesium stearate; E141; E160a, liquid paraffin; solid paraffin; sucrose.
06.2 Incompatibility "-
Not known.
06.3 Period of validity "-
3 years.
06.4 Special precautions for storage -
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package -
The product is packaged in blister packs in coupled aluminum and plastic material enclosed in a cardboard box together with the package leaflet.
Box of 20 coated tablets, in blister
06.6 Instructions for use and handling -
No special instructions for disposal.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Meda Pharma S.p.A.
Viale Brenta 18
20139 Milan
08.0 MARKETING AUTHORIZATION NUMBER -
Librax 20 coated tablets - AIC n. 019711035
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
First authorization: October 1999
Renewal June 2010
10.0 DATE OF REVISION OF THE TEXT -
AIFA Determination of February 16, 2015
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