Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The following classification is used for the frequency of adverse reactions: 
Very common:        more than 1 in 10 treated persons
Common:             1 to 10 in 100 treated persons
Uncommon:           1 to 10 in 1,000 treated persons
Rare:               1 to 10 in 10,000 treated persons
Very rare:          less than 1 in 10,000 treated persons
Not known:          cannot be estimated from the available data
Gastrointestinal complaints, such as stomach pain, heartburn, nausea or diarrhoea, are uncommon during the use of Kaloba® Syrup.
In rare cases, slight gingival bleeding or nosebleeds may occur. Furthermore, hypersensitivity reactions (exanthema, urticaria, pruritus of the skin and mucous membranes) have been described in rare cases. Such reactions may occur even when taking the medicine for the first time.
In very rare cases, severe hypersensitivity reactions with facial swelling, dyspnoea and hypotension may occur.
Hepatic dysfunction of various aetiologies. No causal relationship with the use of Kaloba® Syrup has been established. The frequency is not known.
Increased liver values have been observed occasionally during treatment.
Reduced platelet levels have been observed during treatment (frequency not known). These may, however, be caused by the underlying disease

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the risk/benefit ratio 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