Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Adverse reactions listed below are classified according to frequency and system organ class (SOC). Frequency categories are defined according to the following convention: 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).
No differences were observed in the frequency of adverse reactions between Tesalin and placebo in clinical trials.

Gastrointestinal tract:
Common: gastrointestinal discomfort such as nausea, diarrhoea and abdominal pain.
Skin:
Uncommon: hypersensitivity reactions of the skin with erythema, oedema, and pruritus.

Nervous system:
Unknown: headache
Immune system:
Unknown: hypersensitivity reactions

Liver damage:

Very rare cases of liver damage, including some serious cases, have been observed in association with preparations containing a CO2-extract made from roots of Petasites hybridus.
However, a liver damaging effect cannot be excluded for the CO2-extract made from leaves of Petasites hybridus (Ze 339), which is contained in Tesalin. Please refer to « Special warnings and precautions for use ».


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/