Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Not known        Very rare      Rare                    Uncommon           Common         System Organ (cannot be       <1/10,000      >1/10,000,<1/1000       >1/1000,           >1/100,        Class estimated                                               <1/100             <1/10 from the available data) syncope                 headache           dizziness      Nervous system (1.3%)         disorders
Vision                                                                                    Eye disorders blurred *
Visual impairment
* palpitations                      Cardiac disorders postural                          Vascular disorders hypotension
Epistaxis*                                              rhinitis                          Respiratory, thoracic and mediastinal disorders
Dry mouth*                                              constipation,                     Gastrointestinal diarrhoea,                        disorders nausea,
vomiting
Erythema         Stevens-       angioedema              rash, pruritus,                   Skin and multiforme*      Johnson                                urticaria                         subcutaneous Dermatitis       syndrome                                                                 tissue disorders exfoliative* priapism                                                  ejaculation    Reproductive disorders,     system and breast including      disorders retrograde ejaculation and ejaculation failure asthenia                          General 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 of 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