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LYSANXIA 15 mg/mL Oral drops, solution Bottle/20mL

Alfasigma France

LYSANXIA 15 mg/mL Oral drops, solution Bottle/20mL

CIP / EAN code: 3400933116866

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Product information

Find indications, dosage and precautions in the sections below.

Automatic English translation of the French VIDAL document. Original numerical values and units are retained, including decimal commas.

VIDAL
Medicines
Update of 25/03/2026

LYSANXIA®
prazepam


Forms and presentations

Oral solution at 15 mg/ml: Bottle of 20 ml (600 drops), with dropper.


Composition

  for 100 ml
Prazepam 
1,500 g
Excipients: propylene glycol, ethyldiethylene glycol (monoethyl ether of diethylene glycol, purified by rectification), sodium saccharin, polysorbate 80, menthol, anethole, patent blue V.

1 ml of solution corresponds to 30 drops containing 15 mg of prazepam.


Indications

  • Symptomatic treatment of severe and/or disabling anxiety manifestations.
  • Prevention and treatment of delirium tremens and other manifestations of alcohol withdrawal.

Dosage and administration

The use of prazepam is not recommended in children.

Dose:
In all cases, treatment will be initiated at the lowest effective dose and the maximum dose will not be exceeded.
  • In adults: in common practice, 10 to 30 mg per day divided into several doses throughout the day, i.e. 20 to 60 drops per day.
  • In children, the elderly, patients with renal insufficiency or hepatic insufficiency: it is recommended to reduce the dosage, by half for example.
Duration of treatment:
  • Treatment should be as short as possible. The indication will be reassessed regularly, especially in the absence of symptoms. The overall duration of treatment should not exceed 8 to 12 weeks for the majority of patients, including the dose-reduction period (see Warnings and Precautions for Use).
    In some cases, it may be necessary to extend treatment beyond the recommended periods. This requires precise and repeated assessments of the patient's condition.
  • Prevention and treatment of delirium tremens and other manifestations of alcohol withdrawal: short treatment of the order of 8 to 10 days.

Contraindications

This medicine must never be used in the following situations:
  • Hypersensitivity to the active substance or to any of the excipients listed in section Composition.
  • Severe respiratory failure.
  • Sleep apnoea syndrome.
  • Severe hepatic insufficiency, acute or chronic (risk of encephalopathy).
  • Myasthenia.

Warnings and precautions


Warnings:

This specialty contains terpene derivatives, as excipients, which may lower the seizure threshold. At excessive doses, risk of neurological accidents such as convulsions, particularly in children. Respect the prescribed dosages and duration of treatment.

Pharmacological tolerance:
The anxiolytic effect of benzodiazepines and related medicines may gradually decrease despite use of the same dose when administered over several weeks.
Dependence:
Any treatment with benzodiazepines and related drugs, and more particularly in case of prolonged use, may lead to a state of physical and psychological drug dependence. Various factors seem to favor the occurrence of dependence:
  • duration of treatment,
  • dose,
  • history of other dependencies, drug-related or not, including alcohol.
Drug dependence may occur at therapeutic doses and/or in patients without any individualised risk factor.
This state may lead to a withdrawal phenomenon upon discontinuation of treatment.
Certain symptoms are frequent and appear trivial: insomnia, headaches, significant anxiety, myalgia, muscle tension, irritability. Other symptoms are rarer: agitation, or even a confusional episode, paresthesia of the extremities, hyperreactivity to light, noise, and physical contact, depersonalization, derealization, hallucinatory phenomena, convulsions.
Withdrawal symptoms may appear within the days following discontinuation of treatment. For benzodiazepines with a short duration of action, and especially if given at high doses, symptoms may even appear in the interval between two doses. This is not expected with prazepam because of its long half-life (see Pharmacokinetics).
The combination of several benzodiazepines, whatever the indication, anxiolytic or hypnotic, risks increasing the risk of pharmacodependence.
Cases of abuse have also been reported.
Rebound phenomenon:
This transient syndrome may manifest as an exacerbation of the anxiety that had prompted treatment with benzodiazepines and related drugs.
Amnesia and impairment of psychomotor functions:
Anterograde amnesia as well as impairments of psychomotor functions may occur within hours after intake.
Behavioral disorders:
In some subjects, benzodiazepines and related products may cause a syndrome combining, to varying degrees, an alteration of the state of consciousness and behavioral and memory disorders. The following may be observed:
  • worsening of insomnia, nightmares, agitation, nervousness;
  • delusional ideas, hallucinations, confusional-oneiric state, psychotic-type symptoms;
  • disinhibition with impulsivity;
  • euphoria, irritability;
  • anterograde amnesia;
  • suggestibility.
This syndrome may be accompanied by disorders that are potentially dangerous for the patient or for others, such as:
  • behaviour unusual for the patient;
  • self- or hetero-aggressive behavior, particularly if those around the patient attempt to hinder the patient's activity;
  • automatic behaviour with post-event amnesia.
These manifestations require discontinuation of treatment.
Risk of accumulation:
Benzodiazepines and related drugs (like all medications) persist in the body for a period of the order of 5 half-lives (see Pharmacokinetics).
In elderly patients or those suffering from renal or hepatic impairment, the half-life may be considerably prolonged. On repeated administration, the medicine or its metabolites reach the steady-state plateau much later and at a much higher level. Only after a steady-state plateau has been reached is it possible to assess both the efficacy and the safety of the medicine.
A dose adjustment may be necessary (see Posology and Method of administration).
Elderly patients:
Prazepam should be used with caution in elderly patients, due to the risk of sedation and/or musculoskeletal weakness that may increase the risk of falls. Elderly patients should receive a reduced dose (see Posology and Method of administration).
Risk related to concomitant use of opioids:
Concomitant use of Lysanxia and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescription of sedative medicines such as benzodiazepines or related medicines, such as Lysanxia, with opioids should be reserved for patients for whom alternative treatment options are not possible. If the decision is made to prescribe Lysanxia together with opioids, the lowest effective dose should be used and the duration of treatment should be as short as possible.
Patients must be closely monitored to watch for the occurrence of signs and symptoms of respiratory depression and sedation.
In this regard, it is strongly recommended to inform patients and their caregivers so that they are aware of these symptoms (see Interactions).
Precautions for use

The greatest caution is recommended in cases of a history of alcoholism or other dependencies, drug-related or not (see Interactions).

In subjects with a major depressive episode:
Benzodiazepines and related drugs should not be prescribed alone, as they allow depression to progress on its own, with persistence or increase of suicidal risk.
Procedures for progressive discontinuation of treatment:
These must be stated to the patient precisely.
In addition to the need for gradual dose reduction, patients should be warned of the possibility of a rebound phenomenon, in order to minimise the anxiety that could arise from symptoms related to this discontinuation, even if gradual.
The patient must be warned that this phase may be uncomfortable.
Child:
Even more so than in adults, the benefit/risk ratio should be carefully assessed and the duration of treatment kept as short as possible. The use of prazepam is not recommended in children.
Elderly subject, renal or hepatic insufficiency:
The risk of accumulation leads to reducing the dosage, by half for example (see Warnings).
Respiratory insufficiency:
In patients with respiratory insufficiency, the depressant effect of benzodiazepines and related products should be taken into account (all the more so as anxiety and agitation may be signs of an alert to decompensation of respiratory function which justifies transfer to an intensive care unit).

Interactions

Drug interactions

Not recommended:
  • Alcohol: alcohol increases the sedative effect of benzodiazepines and related drugs. Impaired alertness may make driving vehicles and using machines dangerous. Avoid consuming alcoholic beverages and medicines containing alcohol.

To be taken into account:
  • Other central nervous system depressants: morphine derivatives (analgesics, antitussives and substitution treatments other than buprenorphine); neuroleptics; barbiturates; other anxiolytics; hypnotics; sedative antidepressants; sedative H1 antihistamines; central antihypertensives; others: baclofen; thalidomide; pizotifen: increased central depression. Impaired alertness may make driving vehicles and using machines dangerous. In addition, for morphine derivatives (analgesics, antitussives and substitution treatments) and barbiturates: increased risk of respiratory depression, which may be fatal in case of overdose.
  • Buprenorphine: increased risk of respiratory depression, which may be fatal. Carefully assess the benefit/risk ratio of this combination. Inform the patient of the need to comply with the prescribed doses.
  • Opioids: concomitant use of sedative medicinal products such as benzodiazepines or related medicinal products such as Lysanxia with opioids increases the risk of sedation, respiratory depression, coma and death due to a cumulative depressant effect on the central nervous system. The dose and duration of concomitant use should be limited (see Warnings and Precautions for Use).

Fertility, pregnancy and breastfeeding

Pregnancy:

Numerous data from cohort studies have not demonstrated the occurrence of malformative effects following exposure to benzodiazepines during the 1er trimester of pregnancy. However, in certain epidemiological case-control studies, an increased occurrence of cleft lip and palate has been observed with benzodiazepines. According to these data, the incidence of cleft lip and palate in newborns would be less than 2/1000 after exposure to benzodiazepines during pregnancy, whereas the expected rate in the general population is 1/1000.

In case of intake of high doses of benzodiazepines during the 2e and/or 3e trimesters of pregnancy, a decrease in active fetal movements and variability in fetal heart rate have been described.

Treatment at the end of pregnancy with benzodiazepines, even at low doses, may cause signs of impregnation in the newborn such as axial hypotonia and feeding difficulties leading to poor weight gain. These signs are reversible but may last 1 to 3 weeks depending on the half-life of the prescribed benzodiazepine. At high doses, respiratory depression or apnoea and hypothermia may occur in the newborn. Furthermore, neonatal withdrawal syndrome is possible, even in the absence of signs of impregnation. It is characterised in particular by hyperexcitability, agitation and tremors in the newborn occurring at a distance from delivery. The time of onset depends on the elimination half-life of the medicinal product and may be considerable when this is long.

Given these data, as a precautionary measure, the use of prazepam is not recommended during pregnancy, regardless of the stage of pregnancy.

When prazepam is prescribed to a woman of childbearing potential, she should be advised of the need to contact her doctor if pregnancy is planned or begun so that the benefit of treatment can be reassessed.

At the end of pregnancy, if it proves truly necessary to initiate treatment with prazepam, avoid prescribing high doses and take into account, for monitoring the newborn, the effects previously described.


Breastfeeding:

The use of this medicine during breastfeeding is not recommended.


Driving and using machines

Warn drivers of vehicles and users of machinery of the possible risk of drowsiness.
The association with other sedative medications should be discouraged or taken into account when driving or operating machinery (see Interactions).
If the duration of sleep is insufficient, the risk of impaired alertness is further increased.

Adverse effects

They are related to the dose ingested and the individual sensitivity of the patient.

  • Neuro-psychiatric adverse effects (see Warnings and Precautions for Use) :
    • anterograde amnesia, which may occur at therapeutic doses, the risk increasing in proportion to the dose;
    • behavioural disorders, changes in consciousness, irritability, aggressiveness, agitation;
    • physical and psychological dependence, even at therapeutic doses, with withdrawal or rebound syndrome on discontinuation of treatment;
    • dizziness, headache, ataxia;
    • confusion, reduced alertness, or even drowsiness (particularly in the elderly), insomnia, nightmares, tension;
    • changes in libido.
  • Skin adverse effects: skin rashes, pruritic or not.
  • General adverse effects: muscle hypotonia, asthenia.
  • Eye adverse effects: diplopia.
Due to the presence, as excipients, of terpene derivatives, and in case of failure to respect the recommended doses:
  • risk of convulsions in infants and children,
  • possibility of agitation and confusion in elderly subjects.
Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres. Website: https://signalement.social-sante.gouv.fr.


Overdose

The vital prognosis may be threatened, particularly in cases of polyintoxication involving other central nervous system depressants (including alcohol).

In case of massive ingestion, signs of overdose manifest mainly as depression of the central nervous system ranging from drowsiness to coma, depending on the amount ingested.

Mild cases manifest as signs of mental confusion and lethargy.

More serious cases manifest as ataxia, hypotonia, hypotension, respiratory depression, and, exceptionally, death.

In case of oral overdose prior to 1 hour, induction of vomiting will be performed if the patient is conscious or, failing that, gastric lavage with protection of the airways. After this period, administration of activated charcoal may help reduce absorption.

Particular monitoring of cardiorespiratory functions in a specialised setting is recommended.

Administration of flumazenil may be useful for the diagnosis and/or treatment of an intentional or accidental benzodiazepine overdose.

Antagonism of the effect of benzodiazepines by flumazenil may promote the occurrence of neurological disorders (convulsions), particularly in epileptic patients.


Pharmacodynamics

Pharmacotherapeutic class: Anxiolytics (ATC code: N05BA11; N: central nervous system).

Prazepam belongs to the class of 1-4 benzodiazepines and has a pharmacodynamic activity qualitatively similar to that of other compounds of this class:
  • muscle relaxant,
  • anxiolytic,
  • sedative,
  • hypnotic,
  • anticonvulsant,
  • amnesic.

These effects are linked to a specific agonist action on a central receptor forming part of the "GABA-OMEGA macromolecular receptor" complex, also called BZ1 and BZ2, and modulating the opening of the chloride channel.


Pharmacokinetics

Distribution:
Prazepam is entirely metabolised to desmethyldiazepam during the first hepatic pass, with a serum peak reached at 4 to 6 hours.
The volume of distribution of desmethyldiazepam is of the order of 1 l/kg.
Protein binding is high, greater than 97 %.
The plasma elimination half-life of prazepam varies from 30 to 150 hours (on average 65 h). The steady state of plasma concentrations is reached in 10 to 15 days.
A concentration-effect relationship could not be established for this class of products, due to the intensity of their metabolism and the development of tolerance.
Benzodiazepines cross the blood-brain barrier, as well as the placenta and breast milk.
Metabolism and elimination:
The liver plays a major role in the metabolism of benzodiazepines, which explains the negligible percentage (1 to 3 %) of unchanged prazepam found in urine.
The main metabolites of prazepam are hydroxylated derivatives; the 3-OH-prazepam is also active, but this metabolite is eliminated much more rapidly than the parent molecule and its pharmacological effect is negligible. Inactivation occurs by glucuroconjugation, resulting in water-soluble substances eliminated in urine.
At-risk population:
Elderly subject: hepatic metabolism decreases as well as total clearance, with increased steady-state concentrations, free fraction and half-lives. Doses should therefore be reduced.

Storage conditions

Shelf life
3 years.

No special precautions for storage.


HANDLING/DISPOSAL INSTRUCTIONS

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


Prescription, supply and reimbursement

LIST I
Prescription duration limited to 12 weeks.
Marketing authorisation (AMM) 3400933116866 (1988, SmPC rev 06.03.2026).
   
Price: 2,09 euros (bottle of 20 ml of oral solution).
Reimbursed by Social Security at 65 %. Collective.

Marketing authorisation holder: Alfasigma S.p.A., Via Ragazzi del'99, N.5, 40133 Bologna (BO), Italy.


ALFASIGMA FRANCE
Bords de Seine 1
3, esplanade du Foncet, 92130 Issy-les-Moulineaux
Tel: 01 45 21 02 69. Fax: 01 41 90 69 76
E-mail: info.fr@alfasigma.com

www.alfasigma.fr

Source: VIDAL · Updated on 11/11/2026. This information does not replace advice from a healthcare professional.