Adverse reactions : תופעות לוואי

4.8 Undesirable effects

General
The frequency and severity of the undesirable effects of lidocaine depend upon the dose, the method of administration and the patient‘s individual sensitivity.

Symptoms of local toxicity may occur after the administration of lidocaine. Systemic adverse effects may be expected at plasma concentrations of lidocaine exceeding 5-10 mg/l. They become manifest in the form of both CNS symptoms and cardiovascular symptoms (see also section 4.9).

The possible undesirable effects after administration of lidocaine as local anaesthetic are largely the same as those produced by other amide-type local anaesthetics.

Listing of undesirable effects
Definition of frequency terms used in this section:
Very common: (≥ 1/10)
Common:           (≥ 1/100 to < 1/10)
Uncommon:         (≥ 1/1,000to < 1/100)
Rare:             (≥ 1/10,000 to < 1/1,000)
Very rare         (< 1/10,000)
Not known:         (frequency cannot be estimated from the available data) 
Local and regional anaesthesia
Blood and the lymphatic system disorders
Not known: Methaemoglobinaemia

Immune system disorders
Rare: Anaphylactic reactions manifesting as urticaria, oedema, bronchospasm, respiratory distress and circulatory symptoms up to anaphylactic shock.

Nervous system disorders
Common: Transient neurological symptoms especially after spinal and epidural anaesthesia, (up to 5 days).
Rare: Neurological complications following central nervous blocks – mainly spinal anaesthesia – such as persistent anaesthesia,paraesthesia, paresis up to paraplegia, Cauda equina syndrome (i.e. bilateral leg weakness up to paraplegia, saddle anaesthesia,urinary retention and fecal incontinence), headache accompanied by tinnitus and photophobia
Cranial nerve lesions, neurosensory deafness (if administered in head and neck regions).
Horner’s syndrome, associated with epidural anaesthesia or regional applications in the head/neck region.

Gastrointestinal disorder
Very common: Nausea, vomiting

Injury, poisoning and procedural complications
Rare: Trauma, transient radicular irritation due to spinal anaesthesia, compression of the spinal cord after development of haematoma 
General disorders and administration site conditions
Rare: Shivering (after epidural use)

Information on particular undesirable effects none
Paediatric population
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.

Elderly patients
In elderly patients the incidence of undesirable effects may be increased (see section 4.4).

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))