Adverse reactions : תופעות לוואי

4.8 Undesirable effects

The assessment of undesirable effects is based on the following frequencies: - 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)
— Unknown (frequency cannot be assessed on the basis of the available data) 
Possible undesirable effects:

Immune system disorders
Very rare: Allergic reactions (anaphylactic shock in the most severe cases) to a local anaesthetic of the amide type and/or to chlorhexidine
Very rare: hypersensitivity reactions, including late reactions, due to chlorhexidine and/or methyl or propyl 4‐hydroxybenzoate

Injuries, poisoning and complications due to procedures
Unknown: Despite the proven great safety range of Instillagel, with severe urethral injuries systemic undesirable effects of the local anaesthetic lidocaine are possible, such as anaphylactic shock, fall in blood pressure, bradycardia or seizures.

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/