Adverse reactions : תופעות לוואי

4.8     Undesirable effects
As all paracetamol products, adverse drug reactions are rare (≥1/10000 to <1/1000) or very rare (<1/10000). They are described below:
System Organ Class        Rare (≥1/10000                Very rare                   Not known to <1/1000)                   (<1/10000)                  (cannot be estimated from the available data)



Blood and the lymphatic       -                            Thrombocytopenia,              - system disorders                                           Leucopenia, Neutropenia
Immune system                 -                            Hypersensitivity               - disorders                                                  reaction (1, 3) Cardiac                       -                            -                              Tachycardia (2) disorders
Vascular disorders            Hypotension                  -                              Flushing (2) Hepatobiliary                 Increased levels of          -                              - disorders                     hepatic transaminases
Skin and subcutaneous         -                            serious skin reactions (3)     Pruritus (2), tissue disorders                                                                          Erythema (2) General                       Malaise                      -                              - disorders and administration site conditions

(1) Very rare cases of hypersensitivity reactions ranging from simple skin rash or urticaria to an- aphylactic shock have been reported and require discontinuation of treatment.
(2) Isolated cases
(3) Very rare cases of serious skin reactions have been reported.

Frequent adverse reactions at injection site have been reported during clinical trials (pain and burning sensation).

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/