|During the first week of administration or when high doses are used they may have a sedative effect and cause some degree of drowsiness. In such cases there is an advantage in administering half the total daily intake at night, the remainder being given in divided doses during the day. The elderly and debilitated are particularly sensitive to the effects of central depressant drugs and may experience confusion, especially if organic brain changes are present; the dosage of diazepam should not exceed one-half that recommended for other adults.|
Skin and appendages disorders Allergic reactions (skin rash or itching) occur rarely.
Central and peripheral nervous disorders Drowsiness, sedation, unsteadiness, ataxia is common (these effects are dose-related and may persist into the following day even after a single dose), light-headedness, headache, vertigo, dystonic effects occur rarely. Impaired motor ability, dizziness, muscle weakness, tremor, slurred speech.
Vision disorders Visual disturbances occur rarely.
Psychiatric disorders Libido fluctuations occur rarely. Anterograde amnesia (amnesia may be associated with inappropriate behaviour), concentration difficulties, abnormal psychological reactions, behavioural adverse effects include paradoxical aggressive outbursts, excitement, confusion, restlessness, agitation, irritability, delusions, rages, nightmares, hallucinations, psychoses, inappropriate behaviour, numbed emotions, the uncovering of depression with suicidal tendencies and dependence (see section 4.4). Abuse of benzodiazepines has been reported.
Gastro-intestinal system disorders Gastrointestinal upsets occur rarely. Increased salivary secretion.
Liver and billiary system disorders Jaundice occurs rarely.
Endocrine disorders Gynaecomastia.
Cardio disorders Hypotension occurs rarely.
Respiratory system disorders Respiratory depression, apnoea.
Blood disorders Blood dyscrasias occur rarely.
Urinary system disorders Urinary retention occurs rarely.
Body as a whole-general disorders Fatigue, anaphylaxis.
General disorders and administration site conditionsThis formulation may rarely cause local pain of thrombophlebitis in the vein used for administration.Rare instances have been reported of a local painless erythematous rash round the site of injection, which has resolved in 1-2 days. Urticaria and, rarely anaphylaxis have been reported following the injection of Diazemuls.
Withdrawal effectsWithdrawal symptoms: Development of dependence is common after regular use, even in therapeutic doses for short periods, particularly in patients with a history of drug or alcohol abuse or marked personality disorders. Discontinuation of the therapy may result in withdrawal or rebound phenomena (see 4.4 Special Warnings and Special Precautions for Use). Symptoms of benzodiazepine withdrawal include anxiety, depression, impaired concentration, insomnia, headache, dizziness, tinnitus, loss of appetite, tremor, perspiration, irritability, perceptual disturbances such as hypersensitivity to physical, visual, and auditory stimuli and abnormal taste, nausea, vomiting, abdominal cramps, palpitations, mild systolic hypertension, tachycardia, and orthostatic hypotension.Rare and more serious symptoms include muscle twitching, confusional or paranoid psychosis, convulsions, hallucinations, and a state resembling delirium tremens. Broken sleep with vivid dreams and increased REM sleep may persist for some weeks after withdrawal of benzodiazepines.