Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Very common:                       ≥ 1/10
Common:                            ≥ 1/100, < 1/10
Uncommon:                          ≥ 1/1,000, < 1/100
Rare:                              ≥ 1/10,000, < 1/1,000
Very rare:                         < 1/10,000
Not known:                         Frequency cannot be estimated from the available data 
System organ class                           Adverse reaction               Frequency 
Metabolic and nutritional disorders   Hyperkalaemia1                               Not known Nausea2
Gastrointestinal disorders                                                            Rare Flatulence2
System organ class                         Adverse reaction                   Frequency Vomiting2
Abdominal pain2
Diarrhoea2
Occlusion3
Bleeding3
Very rare
Ulceration3
Perforation3
Skin and subcutaneous tissue         Pruritus disorders                            Rash                                               Rare Urticaria

1   Dangerous hyperkalaemia may occur in patients whose potassium excretion or distribution in the body is disrupted (see sections 4.3 and 4.4).
2   Oral intake of potassium salts may lead to those adverse reactions. The reason for this is mucous membrane irritations of the gastrointestinal tract, which can be best reduced through increased fluid intake (as possible) and by concomitantly taking the medicinal product during or after meals or taking a reduced dosage.
3   See section 4.4. For most of these patients other simultaneous factors existed, which could be associated with such unwanted reactions (e.g. delayed intestinal passage or obstruction of the gastrointestinal tract).

Reporting 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/