Section 4.3
Addition of respiratory depression, acute pulmonary insufficiency, severe hepatic impairment.
Section 4.4
Myasthenia gravis, transfer of information from section 4.3 to 4.4.
Addition of coma.
Addition of the following text: “The elderly are more prone to the CNS effects of benzodiazepines and therefore, lower doses are required”.
Addition of withdrawal symptoms.
Section 4.5
This section has been re-structured as per the BNF
Addition of the following:
· Antibacterials: erythromycin
· Antidepressants: fluvoxamine
· Antiepileptics: carbamazepine and sodium valproate.
· Clozapine (Severe hypotension, collapse, respiratory depression, potentially fatal respiratory arrest and unconsciousness have been reported in a few patients on benzodiazepines and clozapine. Caution is advised when initiating clozapine therapy in patients taking benzodiazepines).
· Digoxin
· HIV-protease inhibitors: amprenavir and ritonavir
· Muscle relaxants – text amended
Section 4.6
Addition of the following text:
“There may be a small increase in the risk of congenital malformation, particularly oral cleft, with the use of benzodiazepines in the first trimester”.
“A small number of children exposed in utero to benzodiazepines have shown slow development in the early years but by four years of age have developed normally”.
Section 4.8
Section re-structured by organ/system.
Hypotension - relocating information and amending
Addition of hypersensitivity reactions, including anaphylaxis. Paradoxical reactions, gynaecomastia, respiratory depression (relocating information and amending).
Elderly and debilitated and side effects, restructuring of information and supplementary.
Removal of the following side effects no longer substantiated/justified:
· Double vision
· Increased appetite
· Laryngeal spasm
· Menstrual disturbances
Section 4.9
Supplementary information added regarding the symptoms of overdose and treatment (activated charcoal).
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