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Examiné médicalement par Oliinyk Elizabeth Ivanovna, Pharmacie Dernière mise à jour le 21.03.2022
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Limovane is indicated for the short-term treatment of insomnia in adults.
Benzodiazepines and benzodiazepine-like agents are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. Long term continuous use is not recommended. A course of treatment should employ the lowest effective dose.
The lowest effective dose should be used.
Limovane should be taken in a single dose and not re-administered during the same night.
Treatment duration
Treatment with Limovane should be as short as possible. Generally the duration of treatment varies from a few days to two weeks with a maximum, including the tapering off, of four weeks.
In certain cases an extension beyond the maximum treatment period may be necessary; if so it should take place after re-evaluation of the patient's status.
Posology
Adults:
The recommended dose for adults is 2 tablets (7.5 mg Limovane). This dose should not be exceeded. The tablet should be taken just before retiring.
Impaired renal function:
Although accumulation of Limovane and/or its metabolites has not been shown in patients with impaired renal function, a starting dose of 3.75 mg is recommended in these patients.
Impaired hepatic function:
As elimination of Limovane may be reduced in patients with hepatic dysfunction, a lower dose of 3.75 mg Limovane nightly is recommended.
The standard dose of 7.5 mg Limovane may be used with caution in some cases depending on effectiveness and acceptability.
Chronic respiratory insufficiency:
In patients with chronic respiratory insufficiency, a starting dose of 3.75 mg Limovane is recommended initially. The dosage subsequently may be increased to 7.5 mg.
Elderly:
A starting dose of 3.75 mg is recommended, this dose may consequently be increased to 7.5 mg if considered clinically necessary depending on patient effectiveness and acceptability.
Paediatric population:
Limovane should not be used in children and adolescents less than 18 years. The safety and efficacy of Limovane in children and adolescents aged less than 18 years have not been established.
Method of administration
Limovane is for oral use only.
Limovane is contraindicated in patients with any of the following:
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- Myasthenia gravis
- Severe hepatic impairment
- Sleep apnoea syndrome
- Respiratory failure
Limovane should not be given to children or adolescents younger than 18 years of age.
Risk of dependence:
Clinical experience to date suggests that the risk of dependence is minimal when the duration of treatment is limited to not more than 4 weeks, however, as with the benzodiazepines and other benzodiazepine-like drugs (even at therapeutic doses), there is a risk of physical and psychological dependence or abuse. This risk increases with dose and length of treatment and use with alcohol or other psychotropics. Patients with a history of alcohol and/or drug abuse or those with personality disorders are more at risk of dependence and this should be considered when prescribing Limovane. If a patient does become dependent, abrupt cessation of treatment may result in withdrawal symptoms including: extreme anxiety, headaches, muscle pain, tension, confusion and restlessness and irritability. In severe cases symptoms may also include depersonalisation, derealisation, numbness and tingling of the extremities, hypersensitivity to noise, light and physical contact, hallucinations or epileptic seizures.
Rare cases of abuse have been reported.
Withdrawal:
Patients with a history of depression, anxiety or psychotic disorders:
Benzodiazepines and benzodiazepine-like substances, such as Limovane, are not recommended as the primary treatment of psychoses.
Limovane does not constitute a treatment for depression (or anxiety linked with depression) and may even mask its symptoms (suicide may be precipitated in such patients).
Zimovane should be administered with caution in patients exhibiting symptoms of depression. Suicidal tendencies may be present therefore the least amount of Zimovane that is feasible should be supplied to these patients to avoid the possibility of intentional overdosage by the patient. Pre-existing depression may be unmasked during use of Zimovane. Since insomnia may be a symptom of depression, the patient should be re-evaluated if insomnia persists.
Any underlying cause of the insomnia should also be addressed before symptomatic treatment to avoid under treating potentially serious effects of depression.
Tolerance:
Some loss of efficacy to the hypnotic effects of benzodiazepines and benzodiazepine-like agents may develop after repeated use for a few weeks. However, with Limovane no marked tolerance occurred during treatment periods of up to four weeks.
Rebound insomnia:
A transient syndrome where the symptoms which led to treatment with a benzodiazepine or benzodiazepine-like agent recur in an enhanced form on discontinuation of therapy. It may be accompanied by other reactions including mood changes, anxiety and restlessness. Since the risk of withdrawal/rebound phenomena may be increased after prolonged treatment, or abrupt discontinuation of therapy, it is therefore, recommended to decrease the dosage gradually and to advise the patient accordingly.
A course of treatment should employ the lowest effective dose for the minimum length of time necessary for the effective treatment. A course of treatment should not continue for longer than 4 weeks including any tapering off.
Amnesia:
Amnesia is rare, but anterograde amnesia may occur, especially if sleep is interrupted or when retiring to bed is delayed after taking the tablet. Situations when this might occur should therefore be avoided and the patient should ensure that they are able to have a full night's sleep (uninterrupted sleep of about 7 to 8 hours).
Psychomotor impairment
Like other sedative/hypnotic drugs, Limovane has CNS-depressant effects. The risk of psychomotor impairment, including impaired driving ability, is increased if: Limovane is taken within 12 hours of performing activities that require mental alertness, a dose higher than the recommended dose is taken, or Limovane is co-administered with other CNS depressants, alcohol or with other drugs that increase the blood levels of Limovane. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness or motor coordination such as operating machinery or driving a motor vehicle following administration of Limovane and in particular during the 12 hours following that administration.
Risks from concomitant use of opioids and benzodiazepines:
Concomitant use of benzodiazepines, including Limovane, and opioids may result in sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of opioids and benzodiazepines for use in patients for whom alternative treatment options are inadequate.
If a decision is made to prescribe Limovane concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation.
Psychiatric and 'paradoxical' reactions:
It is known that reactions such as restlessness, agitation, irritability, aggression, delusion, outbursts of rage, nightmares, hallucinations, psychoses, unsuitable behaviour and other behavioural disturbances may occur during the use of benzodiazepines and benzodiazepine-like substances. If this is the case administration of the medicinal product should be discontinued. These reactions are more likely to occur in the elderly.
Somnambulism and associated behaviours:
Sleepwalking and other associated behaviours such as 'sleep driving', preparing and eating food or making phone calls with amnesia for the event, have been reported in patients who have taken Limovane and were not fully awake. It appears that there is an increased risk of such behaviour with the concomitant use of alcohol, other CNS depressants or the use of Limovane at doses exceeding the maximum recommended dose. If such behaviours are reported, administration of Limovane should be discontinued.
Specific patient groups:
Use in elderly
Hypnotics should be avoided in the elderly who are at risk of becoming ataxic and confused and so liable to fall and injure themselves. If, based on clinical need, a decision to treat is nevertheless taken, treatment should be initiated at a lower dose and co-administration of Limovane with CYP3A4 inhibitors should be avoided.
Use in respiratory insufficiency
As hypnotics have the capacity to depress respiratory drive, precautions should be observed if Limovane is prescribed to patients with compromised respiratory function. A lower dose is advised for patients with chronic respiratory insufficiency due to the risk of respiratory depression.
Use in hepatic insufficiency
A reduced dosage is recommended,. Benzodiazepines and benzodiazepine-like substances are not suitable for the treatment of patients with severe hepatic insufficiency, since they may promote the occurrence of encephalopathy.
Use in renal insufficiency
A reduced dosage is recommended,.
Period of treatment:
The period of treatment should be as short as possible but not longer than 4 weeks including the tapering off process. This period should only be exceeded after re-evaluation of the patient's condition. It may be of benefit to inform the patient at the beginning of treatment that the treatment will be of short duration, and to explain precisely how to reduce the dose gradually. It is also important to point out to the patient the possibility of the occurrence of rebound phenomena in order to keep to a minimum any worries about the occurrence of such symptoms during the tapering off period of the treatment. In the case of benzodiazepines and benzodiazepine-like substances with a short period of action, there are indications that withdrawal symptoms may occur within the dosage interval, especially if the dose is high.
Paediatric population:
Limovane should not be used in children and adolescents less than 18 years. The safety and efficacy of Limovane in children and adolescents aged less than 18 years have not been established.
Excipients:
Lactose:
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Ponceau 4R (E124):
May cause allergic reactions.