Adverse reactions : תופעות לוואי

4.8.    Undesirable Effects
 a. Summary of the safety profile
The most frequent and very common adverse reactions related to propafenone therapy are dizziness, cardiac conduction disorders and palpitations.
b. Tabulated summary of adverse reactions

The following table displays adverse reactions reported in clinical trials and from post-marketing experience with propafenone.

The reactions considered at least possibly related to propafenone are displayed by system organ class and frequency using the following convention: very common (≥1/10), common (≥ 1/100 to < 1/10), uncommon (≥1/1,000 to < 1/100) and not known (adverse reactions from post-marketing experience; cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness when the seriousness could be assessed. The frequencies are based on clinical trial data from propafenone SR.
It is expected that the adverse reactions and frequencies for IR formulations would be similar.

System Organ          Very common       Common              Uncommon              Not Known Class                 ≥1/10             ≥ 1/100 to < 1/10   ≥1/1,000 to < 1/100   (cannot be estimated from the available data)
Blood and                                                   Thrombocytopenia      Agranulocytosis lymphatic system                                                                  Leukopenia disorders                                                                         Granulocytopenia 
Immune system                                                                     Hypersensitivity1 disorders
Metabolism and                                              Decreased appetite nutrition disorders
Psychiatric                             Anxiety             Nightmare             Confusional state disorders                               Sleep disorders

Nervous system        Dizziness2        Headache            Syncope               Convulsion disorders                               Dysgeusia           Ataxia                Extrapyramidal Paraesthesia          symptoms
Restlessness
Eye disorders                           Vision blurred

Ear and labyrinth                                           Vertigo

disorders
Cardiac disorders     Cardiac              Sinus bradycardia Ventricular                Ventricular conduction           Bradycardia       tachycardia                fibrillation disorders3           Tachycardia       Arrythmia4                 Cardiac failure5 Palpitations         Atrial flutter                               Heart rate reduced 
Vascular disorders                                              Hypotension             Orthostatic hypotension
Respiratory,                               Dyspnoea thoracic and mediastinal disorders
Gastrointestinal                           Abdominal pain       Abdominal               Retching disorders                                  Vomiting             distension              Gastrointestinal Nausea               Flatulence              disturbance
Diarrhoea
Constipation
Dry mouth
Hepatobiliary                              Hepatic function                             Hepatocellular injury disorders                                  abnormal6                                    Cholestasis Hepatitis
Jaundice
Skin and                                                        Urticaria               Acute generalized subcutaneous tissue                                             Pruritus                exanthematous disorders                                                       Rash                    pustulosis Erythema
Musculoskeletal                                                                         Lupus-like syndrome and connective tissue disorders
Reproductive                                                    Erectile dysfunction    Sperm count system and breast                                                                       decreased7 disorders
General disorders                          Chest pain and administration                         Asthenia site conditions                            Fatigue
Pyrexia
1
May be manifested by cholestasis, blood dyscrasias and rash
2
Excluding vertigo
3
Including sinoatrial block, atrioventricular block and intraventricular block 4
Propafenone may be associated with proarrhythmic effects which manifest as an increase in heart rate (tachycardia) or ventricular fibrillation. Some of these arrhythmias can be life- threatening and may require resuscitation to prevent a potentially fatal outcome 5
An aggravation of preexisting cardiac insufficiency may occur
6
This term covers abnormal liver function tests, such as aspartate aminotransferase increased, alanine aminotransferase increased, gamma-glutamyltransferase increased and blood alkaline phosphatase increased
7
Decreased sperm count is reversible upon discontinuation of propafenone 

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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 http://sideeffects.health.gov.il