Adverse reactions : תופעות לוואי

4.8 Undesirable effects

The adverse reactions observed in clinical studies and reported in post-marketing experience are detailed below. Post-marketing adverse reactions are designated with a frequency “not known”.
Adverse reactions frequency is defined using the following convention: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).

Rare                  Very rare                Not known
Blood and                                                         Leukocytopenia lymphatic                                                         Thrombocytopenia system disorders
Nervous            Dizziness                                      Headache system             Somnolence                                     Vertigo disorders
Respiratory                                                       Pneumonitis or thoracic                                                          Pulmonary fibrosis (Isolated and mediastinal                                                   cases) disorders
Gastrointestinal                                                  Nausea2 disorders                                                         Vomiting2 Diarrhoea2
Dyspepsia2
Abdominal pain2
Hepatobiliary                            Cholestasis or           Cholelithiasis3 disorders                                Cytolysis3
Skin and                                 Photosensitivity         Rash, urticarial, pruritis and subcutaneous                                                      eczema (mainly allergic) tissue disorders                                                  Alopecia Musculoskeletal Rhabdomyolysis1                                   Myalgia1 and and                                                               myopathy1including connective                                                        myositis1 tissue disorders
Reproductive                                                      Erectile dysfunction system and breast disorders
General          Fatigue disorders and administration site conditions
Investigations                                                    Blood creatine phosphokinase increased
Liver function test
Abnormal3
1
In the majority of cases muscle toxicity is reversible when treatment is withdrawn (see section 4.4).
2
Generally, these side effects were mild to moderate in nature and occurred early on, becoming less frequent as treatment progressed.
3
As with other fibrates, abnormal hepatic function tests have been observed occasionally.
Very rare cases of cholestasis or cytolysis have been reported (see section 4.4).
Exceptional cases with chronic evolution have been observed. Some cases of cholelithiasis have been reported.

Reporting of 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/