|The following have been observed: |
Immune System DisordersAllergic reactions and very rare cases of anaphylaxis have been reported to occur with benzodiazepines. Angioedema may occur in rare cases.
Endocrine DisordersIsolated cases of reversible development of premature secondary sex characteristics in children (incomplete precocious puberty) have been reported.
Psychiatric Disorders and Paradoxical ReactionsImpaired concentration, restlessness, confusional state, disorientation have been observed. Depression may occur in patients treated with Rivotril, but it may be also associated with the underlying disease.The following paradoxical reactions have been observed: excitability, irritability, aggression, agitation, nervousness, hostility, anxiety, sleep disturbances, nightmares, vivid dreams and psychotic disorders and activation of new types of seizures may be precipitated. If these occur, the benefit of continuing the drug should be weighed against the adverse effect. The addition to the regimen of another suitable drug may be necessary or, in some cases, it may be advisable to discontinue Rivotril therapy.
Nervous System DisordersSomnolence, slowed reaction, muscular hypotonia, dizziness and ataxia. These undesirable effects occur relatively frequently and may disappear gradually in the course of the treatment or on reduction of the dosage. They can be partially prevented by increasing the dose slowly at the start of treatment.Headache was observed in rare cases. Causing of generalised fits was observed very rarely.Particularly in long-term or high-dose treatment, reversible disorders such as dysarthria, reduced coordination of movements and gait disorder (ataxia) and nystagmus may occur.Anterograde amnesia may occur using benzodiazepines at therapeutic dosages, the risk increasing at higher dosages. Amnestic effects may be associated with inappropriate behaviour. With certain forms of epilepsy, an increase in the frequency of seizures during long-term treatment is possible. Although Rivotril has been given uneventfully to patients with porphyria, rarely it may induce convulsions in these patients.
Eye DisordersParticularly in long-term or high-dose treatment, reversible disorders of vision (diplopia) may occur. Common: nystagmus
Cardiac DisordersCardiac failure including cardiac arrest has been reported.
Respiratory, Thoracic and Mediastinal System DisordersRespiratory depression may occur, particularly on i.v. administration of clonazepam. This effect may be aggravated by pre-existing airways obstruction or brain damage or if other medications which depress respiration have been given. As a rule, this effect can be avoided by careful adjustment of the dose to individual requirements.Increased salivation or bronchial secretion may occur in infants or young children (see also section 4.4).
Gastrointestinal DisordersThe following effects have been reported in rare cases: nausea, gastrointestinal and epigastric symptoms.
Skin and Subcutaneous Tissue DisordersThe following effects may occur in rare cases: urticaria, pruritus, rash, transient hair loss and pigmentation changes.
Musculoskeletal and Connective Tissue DisordersMuscle weakness, this undesirable effect occurs relatively frequently and is usually transient and generally disappears spontaneously in the course of the treatment or on reduction of the dosage. It can be partially prevented by increasing the dose slowly at the start of treatment.
Renal and Urinary DisordersIn rare cases urinary incontinence may occur.
Reproductive System and Breast DisordersIn rare cases erectile dysfunction or loss of libido may occur.
General Disorders and Administration Site ConditionsFatigue (tiredness, lassitude), this undesirable effect occurs relatively frequently and is usually transient and generally disappears spontaneously in the course of the treatment or on reduction of the dosage. It can be partially prevented by increasing the dose slowly at the start of treatment.
Injury, Poisoning and Procedural ComplicationsAn increased risk for falls and fractures has been reported in elderly benzodiazepine users.
InvestigationsIn rare cases decreased platelet count may occur. As with other benzodiazepines, isolated cases of blood dyscrasias and abnormal liver function tests have been reported.
Dependence and withdrawal, (see 4.4).Paediatric populationFor paediatric specific events please refer to the information listed under headings: Endocrine Disorders and Respiratory, Thoracic and Mediastinal System Disorders in section 4.8.