Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The following frequency categories are used for the evaluation of undesirable effects: 
Very common (≥1/10)                           Common (≥1/100, <1/10) Uncommon (≥1/1000, <1/100)                    Rare (≥1/10000, <1/1,000) Very rare (<1/10000)                          Not known (frequency cannot be estimated from the available data)

Gastrointestinal disorders
Frequency not known: Gastrointestinal symptoms (i.e. dyspeptic disorders, diarrhoea) Hepatobiliary disorders
Frequency is not known: Liver toxicity (including hepatitis, jaundice, disturbances in the liver function tests) is associated with the use of Cimicifuga containing products.
Skin and subcutaneous tissue disorders
Frequency not know: Skin reactions (urticaria, itching, exanthema), facial oedema.
General disorders and administration site conditions
Frequency not known: Peripheral oedema


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/