Adverse reactions : תופעות לוואי

4.8   Undesirable effects
Adverse effects strictly attributable to the local anaesthetic are limited. However, the physiological effects from nerve block are frequent, but these vary considerably depending on what type of block is administered.

The following adverse reactions can occur as a result of the content of lidocaine as local anaesthetic:

FREQUENCY                          DISORDERS                          EFFECTS Rare (≥1/10,000 to <1/1000)        Cardiac disorders                  Hypotension,       arrhythmias, bradycardia, cardiac arrest


LIDOCADREN TEVA RH SY 03.2016

Nervous system disorders        Metallic taste, tinnitus, feeling of dizziness, nausea, vomiting,
anxiety, tremors, nystagmus,
headaches, increased breathing rate.
Paraesthesia          (numbness accompanied by a burning sensation) of the lip and/or tongue
Unconsciousness and seizures,
coma and respiratory arrest (in the event of overdose)

Respiratory disorders           Tachypnoea      followed    by bradypnoea, possibly causing apnoea.
Very rare (< 1/10,000)          General      disorders      and Allergic reactions, skin rash, administration site conditions  erythema, pruritus, oedema of the tongue, mouth, lips or throat and, in the most severe cases, anaphylactic shock.


The following adverse reactions can occur as a result of the content of epinephrine as a vasoconstrictor:


FREQUENCY                       DISORDERS                       EFFECTS Rare (≥1/10,000 to <1/1000)     Cardiac disorders               Hot     sensation,    sweating, migraine-type        headaches,
increased     blood    pressure,
angina pectoris disorders,
tachycardias,
tachyarrhythmias, and cardiac arrest, as well as oedematous swelling of the thyroids.


The following adverse reactions can occur as a result of the content of metabisulfite as an excipient:


LIDOCADREN TEVA RH SY 03.2016

FREQUENCY                         DISORDERS                       EFFECTS Very rare (< 1/10,000)            General      disorders      and Particularly   in    bronchial administration site conditions  asthmatics, allergic reactions which manifest as vomiting,
diarrhoea, wheezing, acute asthma attack, clouding of the consciousness or anaphylactic shock may occur.

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 http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedi c@moh.gov.il