Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Summary of safety profile
The possible undesirable effects due to the use of Ampres are generally similar to the undesirable effects of other local anaesthetics for spinal anaesthesia from the ester group. The undesirable effects induced by the medicinal product are difficult to distinguish from the physiological effects of the nerve block (e.g. reduction in arterial pressure, bradycardia, temporary urine retention), from direct effects (e.g. spinal hematoma) or the indirect effects (e.g. meningitis) of the injection or from the effects due to the loss of cerebrospinal liquid (e.g.
post-spinal headache).


Tabulated summary of adverse reactions
The adverse reactions listed below in Table 1 are classified according to System Organ Class. The frequency of undesirable effects listed below is defined using the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).


Very common           Common                 Uncommon                        Rare                   Very Rare Immune system disorders allergic reactions as a result of sensitivity to the local anaesthetic: characterized by signs such as urticaria,
pruritus, erythema,
angioneurotic edema with possible airway obstruction
(including laryngeal edema),
tachycardia, sneezing,
nausea, vomiting, dizziness,
syncope, excessive sweating,
elevated temperature, and possibly, anaphylactoid type symptomatology (including severe hypotension)
Injury, Poisoning and Procedural Complications anesthetic complication.
Nervous system disorders anxiety,             signs and symptoms        neuropathy, drowsiness restlessness,        of CNS toxicity           merging into paresthesia,         (backache, headache,      unconsciousness and dizziness            tremors possibly          respiratory arrest, spinal proceeding to             block of varying magnitude convulsions,              (including total spinal convulsions,              block), hypotension circumoral                secondary to spinal block,
paresthesia, feeling of   loss of bladder and bowel numbness affecting        control, and loss of perineal the tongue, hearing       sensation and sexual problems, visual          function, arachnoiditis,
problems, blurred         persistent motor, sensory
vision, shaking,         and/or autonomic (sphincter tinnitus, speech         control) deficit of some problems, loss of        lower spinal segments with consciousness).          slow recovery (several months,). cauda equina syndrome and permanent neurological injury.
Eye disorders diplopia
Cardiac disorders arrhythmia, depression of the myocardium, cardiac arrest (the risk is increased by high doses or unintended intravascular injection).
Vascular disorders hypotension.                              bradycardia,
hypertension,
hypotension raised by high doses.
Respiratory, thoracic and mediastinal disorders respiratory depression
Gastrointestinal disorders nausea.             vomiting.


Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il.