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. fall in blood pressure, bradycardia, transient urinary retention), cases caused directly by the needle puncture (e.g. spinal hematoma) or caused indirectly by the needle puncture (e.g. meningitis, epidural abscess) or cases associated with cerebrospinal leakage (e.g. postdural puncture headache).

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



Very common                General disorders: Nausea
(>1/10)                    Cardiac disorders: Hypotension, bradycardia 
Common (>1/100)            Nervous system disorders: Postdural puncture headache Gastrointestinal disorders: Vomiting
Renal and urinary disorders: Urinary retention, urinary incontinence 
Uncommon                   Nervous system disorders: Paraesthesia, paresis, dysesthesia Musculoskeletal and connective tissue disorders: Muscle weakness, back pain Rare (<1/1,000)            Cardiac disorders: Cardiac arrest
General disorders: Allergic reactions, anaphylactic shock
Nervous system disorders: Involuntary total spinal blockade, paraplegia, paralysis, neuropathy, arachnoiditis
Respiratory, thoracic and mediastinal disorders: Respiratory depression 
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
In addition, you can also report to Padagis via the following address: Padagis.co.il