Adverse reactions : תופעות לוואי

4.8. Undesirable effects
Allergic reaction
In extremely rare cases amide-type local anaesthetic preparations have been associated with allergic reaction (in the most severe instances anaphylactic shock).
Local reactions
Local irritations at the application site have been described. Following application to laryngeal mucosa before endotracheal intubation, reversible symptoms such as "sore throat", "hoarseness" and "loss of voice" have been reported. The use of Xylocaine Pump Spray 10% provides surface anaesthesia during endotracheal procedure but does not prevent post-intubation soreness.
Acute systemic toxicity
Systemic adverse reactions are rare and may result from high plasma levels due to excessive dosage or rapid absorption (e.g. following application to areas below the vocal cords), or from hypersensitivity, idiosyncrasy or reduced tolerance on the part of the patient. Such reactions involve the central nervous system and/or the cardiovascular system.
CNS reactions are excitatory and/or depressant and may be characterised by nervousness, dizziness, convulsions, unconsciousness and possibly respiratory arrest. The excitatory reactions may be very brief or may not occur at all, in which case the first manifestations of toxicity may be drowsiness, merging into unconsciousness and respiratory arrest.
Cardiovascular reactions are depressant and may be characterised by hypotension, myocardial depression, bradycardia and possibly cardiac arrest.

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 report to Perrigo via the following address: www.perrigo-pharma.co.il