Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Undesirable effects caused by the medicinal product itself may be difficult to distinguish from the physiological effects of nerve block (e.g. decrease in blood pressure, bradycardia), cases 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, refer to section 4.9, Overdose.


Organ system      Frequency                           Symptoms

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

Central and       Common (≥1/100, <1/10)              Paraesthesia, dizziness peripheral nervous system disorders
Uncommon (≥1/1,000, <1/100)         Symptoms of CNS toxicity
(convulsions, circumoral paraesthesia,
tongue numbness, hyperacousis,
vision disturbances, loss of consciousness, tremor, feeling of intoxication, tinnitus, dysarthria).
Rare (≥1/10,000, <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)              Urine 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 when blockade is given under sedation or general anaesthetic.

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.
Additionally, you can also report to Padagis via the following address: Padagis.co.il.