Adverse reactions : תופעות לוואי

4.8    Undesirable effects
Summary of the safety profile


The most commonly reported adverse reactions are paraesthesias (such as peripheral and peribucal paraesthesias) and gastro-intestinal disorders (such as epigastralgia, diarrhoea, nausea and abdominal pain). The intensity and incidence of most adverse reactions is dose-dependent.

Table 1 below lists the adverse reactions reported with amifampridine.

Tabulated list of adverse reactions
Frequencies are defined as: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000) and Unknown (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Frequencies were estimated based on a clinical study to evaluate the effects of amifampridine on cardiac repolarization at a single dose of 30 mg or 60 mg in healthy volunteers.



Table 1: Adverse Reactions Reported with FIRDAPSE

MedDRA                       MedDRA                                                                 Frequency System organ class           Preferred term
Psychiatric disorders        Sleep disorders, anxiety                                               Unknown Nervous system disorders     Convulsions, chorea, myoclonia drowsiness, weakness, fatigue, headache Unknown Dizziness1, hypoaesthesia1, paraesthesia1                              Very common Eye disorders                Blurred vision                                                         Unknown Cardiac disorders            Cardiac rhythm disorders, palpitations                                 Unknown Vascular disorders           Raynaud's syndrome                                                     Unknown 1
Cold extremities                                                       Common Respiratory, thoracic and    Bronchial hypersecretion, asthma attack in asthmatic patients or patients Unknown mediastinal disorders        with a history of asthma, cough

Gastrointestinal disorders   Hypoaesthasia oral1, paraesthesia oral1, peripheral and peribucal      Very common paraesthesias, nausea1
Abdominal pain                                                         Common 
Diarrhoea, epigastralgia                                               Unknown 
Hepatobiliary disorders      Elevated liver enzyme levels (transaminases)                           Unknown 
Skin and subcutaneous        Hyperhidrosis1, cold sweat1                                            Very common disorders
1
Adverse reactions reported in a clinical study to evaluate the effects of amifampridine on cardiac repolarization at a single dose of 30 mg or 60 mg in healthy volunteers.

Reporting of suspected adverse reactions

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/