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, <1/10 >1/1000, <1/100        >1/10,000,     <1/10,000    (cannot be <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