Adverse reactions : תופעות לוואי

4.8 Undesirable effects
An accurate estimation of the frequency of undesirable effects is not possible due to lacking data.
The following incidence rates are used in the evaluation of undesirable effects:


-   Very common (≥1/10)
-   Common (≥1/100 to <1/10)
-   Uncommon (≥1/1,000 to <1/100)
-   Rare (≥ 1/10,000 to < 1/1,000)
-   Very rare (<1/10,000)
-   Not known (cannot be estimated from the available data)

Adverse reactions rarely occur after the use of Cathejell with Lidocaine, provided that the product is used according to the dosage recommendations/recommendations for use and the necessary precautions are taken.
In rare cases, local and/or systemic hypersensitivity reactions to lidocaine and/or chlorhexidine may occur.

Systemic adverse reactions

Systemic adverse reactions can be caused by high plasma levels, rapid absorption or overdose, as well as by hypersensitivity, idiosyncrasy or reduced tolerance, with possible onset of the following symptoms:

CNS: nervousness, lightheadedness, blurred vision, tremor. These signs may or may not occur. In some patients, intoxication manifests itself in the form of sleepiness, unconsciousness or respiratory arrest.
Cardiovascular: hypotension, bradycardia, asystole. For treatment of intoxication, see section 4.9.
General disorders and administration site conditions
Only low lidocaine blood levels are likely when used in urology; other systemic adverse reactions after instillation of Cathejell with Lidocaine into the urethra (see sections 4.4 and 4.9) are therefore normally not expected.


Immune system disorders
Allergic reactions to local amide-type anaesthetics (in extremely rare cases, anaphylactic shock) are rare. Bronchospasm, respiratory distress syndrome, cutaneous lesions, urticaria and oedema may occur as hypersensitivity to lidocaine or chlorhexidine and should be conventionally treated.


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).