Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The frequencies of undesirable effects are based on the following categories: Very common (≥ 1/10)
Common (≥ 1/100 to < 1/10)
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Uncommon (≥ 1/1,000 to < 1/100)
Rare (≥ 1/10,000 to 1/1,000)
Very rare (< 1/10,000)
Not known (frequency cannot be estimated from the available data)

System organ class              Frequency                          Undesirable effects Immune system disorders         Very rare                          Allergic reactions Skin and subcutaneous           Unknown                            Redness, itching, burning tissue disorder                                                    sensation, skin rash accompanied by pustules.

D limes and linalool may cause allergic reactions.

Reporting of suspected adverse reactions
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.
Healthcare professionals are asked to report any suspected adverse reactions via the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/
 and emailed to the Registration Holder’s Patient Safety Unit at: drugsafety@neopharmgroup.com