tinal disorders
Common:
Dry Mouth
Uncommon:
Mild gastrointestinal disturbances, including nausea and vomiting have occurred
Not Known:
Dyspepsia
Hepatic disorders
Very Rare:
Mild to moderate increases in serum transaminases and/or alkaline phosphatase have been reported very rarely.
Immune System Disorders
Very Rare:
Angioedema and/or anaphylactic reactions have been reported very rarely.
Skin and subcutaneous tissue disorders
Rare:
allergic and allied manifestations such as urticaria, pruritis or rashes have been observed.
Musculoskeletal and connective tissue disorders
Not known:
muscular weakness
General disorders and administration site conditions
Common:
A mild bitter or metallic after-taste is the most frequently reported adverse effect.
Uncommon:
Fatigue
Not Known:
light headedness, incoordination
Injury, poisoning and procedural complications
Rare:
fall (predominantly in elderly patients)
Dependence
Use (even at therapeutic doses) may lead to the development of physical dependence: discontinuation of the therapy may result in withdrawal or rebound phenomena (see section 4.4). Psychological dependence may occur.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the risk/benefit balance of the medicinal product. Healthcare professionals are asked to report and suspected adverse reactions via Yellow Card Scheme atwww.mhra.gov.uk/yellowcard
4.9 Overdose
Fatal dose not known
Symptoms:
Overdose is usually manifested by varying degrees of central nervous system depression ranging from drowsiness to coma according to the quantity ingested.
In the cases of overdosage reported, the main mild effects were drowsiness, confusion, and lethargy and in more severe cases ataxia, AV-block, hypotonia, hypotension, methaemoglobinaemia, respiratory depression and coma has occurred. Overdose should not be life threatening unless combined with other CNS depressants, including alcohol. Other risk factors, such as the presence of concomitant illness and debilitated state of patient, may contribute to the severity of symptoms and very rarely can result in fatal outcome.
Management:
Symptomatic and supportive treatment in adequate clinical environment is recommended, attention should be paid to respiratory and cardiovascular functions.
Consider activated charcoal if an adult has ingested more than 150mg or a child more than 1.5mg/Kg within 1 hour. Alternatively, consider gastric lavage in adults within 1 hour of a potentially life- threatening overdose. If CNS depression is severe consider the use of flumazenil. It has short half-life (about an hour). NOT TO BE USED IN MIXED OVERDOSE OR AS A “DIAGNOSTIC” TEST.
Management should include general symptomatic and supportive measures including clear airway and monitoring cardiac and vital signs until stable.
5. Pharmacological properties
Pharmacotherapeutic group: benzodiazepine related drugs
ATC code: N05CF01
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