Adverse reactions : תופעות לוואי

4.8.   Undesirable effects
The evaluation of adverse reactions is based on the following information on frequency: 
Very common:                               Common:
More than 1 out of 10 treated persons      1 to 10 out of 100 treated persons Uncommon                                   Rare:
1 to 10 out of 1,000 treated persons       1 to 10 out of 10,000 treated persons Very rare:
Less than 1 out of 10,000 treated persons
Not known
Cannot be estimated from the available data

According to the longstanding experience with the application of Pelargonium preparations, the side effects described below may occur when taking medicines containing Pelargonium:
- During treatment with Kaloba® tablets, gastro-intestinal complaints such as stomach pain, heartburn, nausea or diarrhoea occur occasionally.

- In rare cases, mild bleeding from the gums or nose may occur. In addition, hyper- sensitivity reactions (exanthema, urticaria, pruritus of the skin and mucous membranes) have been described in rare cases. Such reactions may already occur on first taking the medicine.

- In very rare cases, severe hypersensitivity reactions with swelling of the face, dyspnoea and drop in blood pressure may occur.

-   Cases of liver damage and hepatitis have been reported in connection with medicinal products containing Pelargonium; 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 (see 4.1).

Reporting suspected adverse reactions after authorization 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