Adverse reactions : תופעות לוואי

4.8. Undesirable effects

Adverse reactions are listed based on the following information about their frequency: 
Very common:                                 Common: affects at least 1 out of 10 treated persons affects at least one and fewer than 10 of 100 treated persons
Uncommon:                                    Rare: affects at least one and fewer than 10 of affects at least one and fewer than 10 of 1,000 treated persons                        10,000 treated persons
Very rare:                                   Not known: affects fewer than 1 in 10,000 treated Cannot be estimated from the available persons                                      data


Immune system disorders:
Frequency not known: In individual cases, severe hypersensitivity reactions with swelling, circulatory complaints and / or respiratory complaints have been reported. In such cases, a doctor must be informed immediately.
If hypersensitivity reactions occur, Lavecalm must be discontinued.


Diseases of the gastrointestinal tract:
Common: eructation
Frequency not known: other gastrointestinal complaints.

Skin and subcutaneous tissue disorders:
Frequency not known: allergic skin reactions.

The following note for the patient is included in the information leaflet: “Please inform your doctor or pharmacist if you are considerably impaired by one of these side effects.”

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: http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEff ectMedic@moh.gov.il Or directly to Dr. Samuelov’s drug safety department at: drugsafety@drsamuelov.co.il