Adverse reactions : תופעות לוואי

4.8. Undesirable effects

Tabulated summary of undesirable effects
The undesirable effects are listed in the table below according to the MedDRA system/organ classes and frequency categories. The CIOMS frequencies are defined as: 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).

System/Organ class       Common           Uncommon        Rare        Very rare      Not known 
Blood and lymphatic                                                                  Neutropoenia; system disorders                                                                     thrombocytopaenia Nervous        system A sensation of Syncope,
disorders             vertigo;       vertigo headache;
debility;
fatigue; and dizziness.
Eye disorders                                                                        Intraoperative floppy iris syndrome (see section 4.4)
Cardiac disorders                         Tachycardia                 Angina         Atrial fibrillation pectoris in coronary patients
(see section 4.4)
Vascular disorders                        Hot flushes;
hypotension
(orthostatic)
System/Organ class       Common          Uncommon        Rare        Very rare      Not known 
(see section 4.4).
Respiratory      system                  Rhinitis disorders
Gastrointestinal        Nausea;          Diarrhoea;
disorders               Abdominal        Vomiting pain;
stomach pain
Hepatobiliary disorders                                                             Hepatocellular injury; cholestatic liver disease.
Skin               and                   Skin    rash;               Urticaria; subcutaneous tissue                      itching                     angioedema disorders
Reproductive system                                                                 Priapism and breast disorders
General disorders      Asthenia          Chest pain;
oedema

The following undesirable effects were described with the form Xatral SR 5 mg and may not be excluded with the form Xatral XL 10 mg:

Nervous system disorders
Uncommon: drowsiness

Eye disorders:
Uncommon: abnormal vision
General disorders
Common: malaise

Cardiac disorders
Uncommon: palpitations

Gastrointestinal disorders
Common: dry mouth
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 at https://sideeffects.health.gov.il