Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Undesirable effects caused by the medicinal product itself can be difficult to distinguish from the physiological effects of the nerve blockade (e.g. decrease in blood pressure, bradycardia), events caused directly by the needle puncture (e.g. nerve damage), or cases caused indirectly by the needle puncture (e.g. epidural abscess).
Neurological injury is a rare but well-known consequential adverse effect of regional anaesthesia, particularly in epidural and spinal anaesthesia.

For information on the symptoms and treatment of acute systemic toxicity, see section 4.9 Overdose.

Organ system       Frequency                           Symptom

Immune system      Rare (≥1/10,000, <1/1,000)          Allergic reactions, anaphylactic shock disorders

Central and        Common (≥ 1/100, < 1/10)            Paraesthesia, peripheral                                             dizziness nervous system disorders
Uncommon (≥ 1/1,000, < 1/100)       Symptoms of CNS toxicity
(convulsions, circumoral paraesthesia,
numbness of the tongue,
hyperacousis, visual disturbances, loss of consciousness, tremor, feeling of intoxication, tinnitus, dysarthria)
Rare (≥ 10,000, <1/1,000)           Neuropathy, peripheral nerve damage, arachnoiditis, paresis, paraplegia


Eye disorders      Rare (≥1/10,000, < 1/1,000)         Double vision Cardiac            Common (≥1/100, < 1/10)             Bradycardia disorders
Rare (≥1/10,000, < 1/1,000)         Cardiac arrest, cardiac arrhythmias Vascular           Very common (≥1/10)                 Hypotension disorders
Common (≥1/100, < 1/10)             Hypertension
Respiratory,       Rare (≥1/10,000, < 1/1,000)         Respiratory depression thoracic and mediastinal disorders
Gastrointestinal   Very common (≥1/10)                 Nausea disorders
Common (≥1/100, < 1/10)             Vomiting
Renal and          Common (≥1/100, < 1/10)             Urinary retention urinary disorders
Hepatobiliary       Not known (cannot be estimated       Impaired hepatic function/increase in disorders           from the available data)             ASAT and ALAT*.

*Hepatic impairment, with reversible increases in ASAT, ALAT, ALP, and bilirubin, have been observed following repeated bupivacaine injections or bupivacaine infusions of long duration. If signs of hepatic impairment are observed during treatment with bupivacaine, the medicinal product must be discontinued immediately. (See section 4.4).

Paediatric population
Adverse reactions in children are similar to those in adults, but it may be difficult to detect early signs of local anaesthetic toxicity in children where the blockade is given under sedation or general anaesthesia.


Reporting 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.