Revision Year: 2011 Publisher: RS & M Consulting GmbH, Industriestrasse 8, D-82194 Groebenzell, GERMANY
Sedalor 2 mg/10 ml solution for injection or for infusion may only be administered under special precautions in patients with
Some loss of efficacy to the hypnotic effects of Lormetazepam may develop after repeated use for a few weeks.
Lormetazepam such as other benzodiazepines has a primary dependency potential that may lead to the development of physical and psychic dependence. There is a risk of dependence, even in the case of daily application for only a few weeks. This applies not only to abuse with particularly high doses, but also to the therapeutic dose range.
Abrupt termination of treatment after longer previous daily administration of Lormetazepam may be accompanied by withdrawal symptoms such as headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability, sleep disturbances and enhanced dreaming. In severe cases derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures may occur.
The following symptoms may occur: Tremor and sweating and may be enhanced up to threatening physical (convulsive attacks) and psychological reactions, such as symptomatic psychosis (such as withdrawal delirium).
Benzodiazepines may induce anterograde amnesia. The condition occurs (most often a few hours) after administration of the product. The patient may then not recall his activities. In order to reduce this dose dependent risk of anterograde amnesia it should be ensured that sufficient uninterrupted sleep of 7 – 8 hours is possible for the patients (see also section 4.8).
Pre-existing depression may be unmasked and may emerge during benzodiazepine treatment. Suicide may be precipitated in such patients. In patients whose anxiety state is superimposed on depression, treatment with benzodiazepines, even if these are not primarily used for anxiolysis, can lead to such severe manifestation of the depressive symptoms after reduction of anxiety that suicidal tendencies become evident. Corresponding precautions must therefore be taken.
Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines.
The possibility of paradoxical reactions such as increased aggressiveness, acute states of excitation, anxiety, suicidal intentions, muscle spasms, disturbed sleep, such as dyskoimesis and dysphylaxia have to be considered.
In case of such reactions, administration of Sedalor 2 mg/10 ml solution for injection or for infusion should be ended.
Psychiatric and paradoxical reactions are more likely to occur in children and the elderly.
If in exceptional cases, repeated administration of Sedalor 2 mg/10 ml solution for injection or for infusion should be necessary, the benefit of the treatment must be outweighed against the risks of development of physical and psychological dependence.
In principle, injections and especially infusions, should be given into large calibre veins. Generally, care should be taken to avoid injections and infusions into small calibre veins to minimize the risk of vein irritations which rises with decrease of vein diameter.
In individual cases, allergic skin reactions (exanthema) and other allergic reactions may occur.
Respiratory depression may occur in patients with airway obstruction and with brain damage.
Generally, patients should be attended 6-12 hours after administration of Sedalor 2 mg/10 ml solution for injection or for infusion.
Especially in cases of high dosages of Lormetazepam or after repeated treatment reversible disorders may occur, such as retarded or indistinct speaking (articulation disorders), movement disorders, unstable way of walking, visual disturbances/impaired vision (double vision) and nystagmus.
The risk of occurrence of undesirable effects is higher in elderly patients. Elderly patients should be warned of the risk of falls due to the myorelaxant effect of Lormetazepam.
Sedalor 2 mg/10 ml solution for injection or for infusion must not be given to children and adolescents, unless administration prior to diagnostic or surgical interventions (anaesthesia, intensive care) is planned.
Mutual enhancement of the effects may occur in cases of concomitant use with other CNS depressants such as neuroleptics, tranquilizers, antidepressant agents, hypnotics, analgesics, anaesthetics and antihistamines.
The effects may also be changed and enhanced, in an unpredictable way, when the product is used in combination with alcohol.
The effects of muscle relaxants may be enhanced.
The nature and extent of interactions cannot be predicted with certainty in patients receiving permanent treatment with other drugs that influence circulatory and respiratory functions (e.g. beta-receptor blockers, cardioactive glycosides, methylxanthines). These also include oral contraceptives and a number of antibiotics.
Therefore, before parenteral administration, the attending doctor should clarify whether the patient is on corresponding permanent treatment.
In such cases, special caution is required on treatment with Lormetazepam.
During pregnancy, Sedalor 2 mg/10 ml solution for injection or for infusion should only be given in exceptional cases and for compelling medical reasons, since no experience in the administration of Lormetazepam to pregnant women has been documented.
Prior to administration of Sedalor 2 mg/10 ml solution for injection or for infusion to a woman of childbearing potential, she should be asked by the physician in charge if she is or suspects to be pregnant.
If benzodiazepines are used repeatedly during pregnancy the child may develop physical dependence, with withdrawal symptoms in the postnatal phase.
If, for compelling medical reasons, Sedalor 2 mg/10 ml solution for injection or for infusion is administered during the late phase of pregnancy, or during labour and delivery, effects on the neonate, such as respiratory depression, hypothermia, reduced muscular tension and sucking difficulties (floppy infant syndrome) can be expected due to the pharmacological action of the compound.
The risk of malformations after therapeutic doses of benzodiazepines during early pregnancy in humans appears to be low, although a number of epidemiological studies have indicated an increased risk of cleft palate. Cases of congenital abnormalities and mental retardation have been reported in children after prenatal exposure, after overdoses and intoxications with benzodiazepines.
Lormetazepam passes into human breast milk. Therefore, Sedalor 2 mg/10 ml solution for injection or for infusion should not be given to nursing mothers. If there are compelling reasons for giving repeated or high dosages of Sedalor 2 mg/10 ml solution for injection or for infusion (e.g. in conditions of anxiety that cannot be controlled by any other means), the child must be weaned, or breast-feeding must be interrupted.
Experiments for Lormetazepam are not available.
Sedalor 2 mg/10 ml solution for injection or for infusion has a major influence on the ability to drive and use machines, as it causes impaired capacity of reaction even in therapeutic use. This applies to an increased extent in association with alcohol.
Therefore patients should not drive or operate machinery or carry out other dangerous activities on the day of their treatment. The decision in each individual case has to be made by the physician in charge and will depend on the individually applied dose and the individual state of reaction of the patient.
In case that Lormetazepam is used for the preparation of a diagnostic intervention, on an outpatient basis, the patient should be discharged only accompanied and should be advised not to take an active part in road traffic.
The following undesirable effects have been observed:
Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system [to be added nationally].
Not applicable.
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