Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Tabulated list of adverse reactions

System Organ       Common        Uncommon       Rare          Very Rare        Not known Class              >1/100,       >1/1000,       >1/10,000,    <1/10,000        (cannot be <1/10         <1/100         <1/1000                        estimated from the available data)
Nervous system     dizziness     headache       syncope disorders          (1.3%)

Eye disorders                                                                  Vision blurred*
Visual impairment*
Cardiac                          palpitations disorders
Vascular                         orthostatic disorders                        hypotension
Respiratory,                     rhinitis                                      Epistaxis* thoracic and mediastinal disorders
Gastrointestinal                 constipation,                                 Dry mouth* disorders                        diarrhoea,
nausea,
vomiting
Skin and                         rash, pruritis, angioedema   Stevens-         Erythema subcutaneous                     urticaria                    Johnson          multiforme* tissue disorders                                              syndrome         Dermatitis exfoliative*
Reproductive       ejaculation                                priapism system and         disorders breast disorders   including retrograde ejaculation and ejaculation failure

General                          asthenia disorders and administration site conditions
*observed post-marketing

As with other alpha-blockers, drowsiness, blurred vision or oedema can occur.
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/