Adverse reactions : תופעות לוואי

4.8    Undesirable effects

In this section, undesirable effects are defined as follows: 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).

Table 1      Frequency of Adverse Reactions
System Organ Class           Frequency                  Event

Blood and lymphatic system     Very common              Anaemia disorders
Immune system disorders        Uncommon                 Hypersensitivity, angioedema and urticaria

Metabolism and nutrition       Common                   Decreased appetite disorders
Psychiatric disorders          Common                   Decreased libido depression

Nervous system disorders       Very common              Dizziness

Common                   Somnolence
Cardiac disorders              Common                   Myocardial infarction (fatal outcomes have been reported)4,
Cardiac failure4

Not known                QT prolongation (see sections 4.4 and 4.5).

Vascular disorders             Very common              Hot flush
Respiratory, thoracic and      Uncommon                 Interstitial lung disease5. (Fatal mediastinal disorders                                   outcomes have been reported).

Gastrointestinal disorders     Very common              Abdominal pain constipation
Nausea

Common                   Dyspepsia flatulence

Hepato-biliary disorders       Common                   Hepatotoxicity, jaundice, hypertransaminasaemia1

Rare                     Hepatic failure2. Fatal outcomes have been reported.

Skin and subcutaneous tissue   Common                   Alopecia disorders                                               hirsutism/hair re-growth dry skin pruritus rash
Rare                        Photosensitivity reaction


Renal and urinary disorders          Very common                 Haematuria 
Reproductive system and              Very common                 Gynaecomastia and breast breast disorders                                                 tenderness3 
Common                      Erectile dysfunction

General disorders and                Very common                 Asthenia administration site conditions                                   Oedema 
Common                      Chest pain

Investigations                       Common                      Weight increased 

1.      Hepatic changes are rarely severe and were frequently transient, resolving or improving with continued therapy or following cessation of therapy.
2.      Listed as an adverse drug reaction following review of post-marketed data. Frequency has been determined from the incidence of reported adverse events of hepatic failure in patients receiving treatment in the open-label Casodex arm of the 150 mg EPC studies.
3.      May be reduced by concomitant castration.
4.      Observed in a pharmaco-epidemiology study of LHRH agonists and anti-androgens used in the treatment of prostate cancer. The risk appeared to be increased when Casodex 50 mg was used in combination with LHRH agonists but no increase in risk was evident when Casodex 150 mg was used as a monotherapy to treat prostate cancer.
5.      Listed as an adverse drug reaction following review of post-marketed data. Frequency has been determined from the incidence of reported adverse events of interstitial pneumonia in the randomised treatment period of the 150 mg EPC studies.

Increased PT/INR: Accounts of coumarin anticoagulants interacting with Casodex have been reported in post marketing surveillance (see sections 4.4. and 4.5).

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