Adverse reactions : תופעות לוואי

4.8 Undesirable effects

MedDRA            Common          Uncommo        Rare               Very rare             Not Known system organ                      n                                                        (Cannot be class             (>1/100,                       (>1/10 000,        ( <1/10 000)           estimated <1/10)          (>1/1000,      <1/1000)                                  from the <1/100)                                                  available data)
Nervous           Dizziness       Headache       Syncope systems           (1.3%) disorders
Eye disorders                                                                               Vision Blurred*
Visual impairment*
Cardiac                           Palpitations disorders
Vascular                          Orthostatic disorders                         hypotensio n
Respiratory,                      Rhinitis                                                  Epistaxis* thoracic and mediastinal disorders
Gastro-                           Constipatio                                               Dry mouth* intestinal                        n,
disorders                         diarrhoea,
nausea,
vomiting
Skin and                          Rash,          Angioedema         Stevens-Johnson         Erythema subcutaneous                      pruritus,                         syndrome                multiforme* tissue                            urticaria                                                 Dermatitis disorders                                                                                   exfoliative Reproductive      Ejaculation                                       Priapism system and        disorders breast            including disorders         retrograde ejaculation and ejaculation failure
General                           Asthenia disorders and administration site conditions

*Observed post-marketing

During cataract and glaucoma surgery a small pupil situation, known as Intraoperative Floppy Iris Syndrome (IFIS), has been associated with therapy of tamsulosin during post-marketing surveillance (see also section 4.4).
Post-marketing experience: In addition to the adverse events listed above, atrial fibrillation, arrhythmia, tachycardia and dyspnoea have been reported in association with tamsulosin use.
Because these spontaneously reported events are from the worldwide post marketing experience, the frequency of events and the role of tamsulosin in their causation cannot be reliably determined.

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/