Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Adverse reactions are listed by body system and by frequency, using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000), and not known (cannot be estimated from the available data).

System Organ Class Frequency Adverse reactions

System Organ Class           Frequency                   Adverse reactions Gastrointestinal disorders   Not known                   Stomach pain Flatulence
Metabolism & nutrition       Not known                   Alkalosis (with prolonged disorders                                                use) Fluid retention*
Hypokalamia
(exacerbation of)
Investigations               Not known                   Increased blood pressure* Respiratory, thoracic &      Not known                   Pulmonary oedema* mediastinal disorders
*sodium supplements may cause these effects in those at risk 
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.