Adverse reactions : תופעות לוואי

4.8    Undesirable effects

As all paracetamol products, adverse drug reactions are rare (≥1/10,000 to <1/1,000) or very rare (<1/10,000).
They are described below:
System Organ Class          Rare                           Very rare                      Not known (≥1/10,000 to                  (<1/10,000)                    (cannot be <1/1,000)                                                     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/ and emailed to the Registration Holder’s Patient Safety Unit at: drugsafety@neopharmgroup.com