Adverse reactions : תופעות לוואי

4.8    Undesirable effects:

The table below summarizes the undesirable effects reported during clinical trials and recorded in the pharmacovigilance database, categorized by system organ class and by frequency. The categories of frequency are defined by applying the following convention: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); and Frequency Unknown (cannot be estimated from the available data).


Very          Common          Uncommon        Frequency Unknown (cannot System Organ common         (≥1/100 to      (≥1/1,000 to     be estimated from the Class
˃1/10)          <1/10)          <1/100)        available data)
Superinfection (in long-term use):
Infections and                                                     colitis due to Clostridium difficile infestations                                                       (Pseudomembranous enterocolitis (see section 4.4).
Blood and                                        Eosinophilia      Thrombocytopenia, neutropenia, lymphatic                                                          agranulocytosis (see section 4.4).
system disorders
Hypersensitivity reactions such as
Immune                                                             urticaria, angioedema, system                                                             bronchospasm, anaphylactoid disorders                                                          reactions or anaphylactic shock 
Psychiatric                                                           Hallucinations, Confusion disorders

Nervous system                Headache,                               Paresthesia, ageusia, dysgeusia, disorders                     dizziness,                              parosmia, anosmia.
Nausea,                                 Bloody diarrhea vomiting,                               pancreatitis.
Gastrointestinal
Dyspepsia disorders
(gastric pain),
diarrhea
Jaundice, cholestatic hepatitis or
Hepatobiliary acute cytolytic hepatitis (see disorders section 4.4)
Rash              Bollous skin          Stevens-Johnson Syndrome (SJS reactions including   ), Toxic Epidermal Necrolysis
Skin and erythema              (TEN) (see section 4.4),
subcutaneous multiforme,            Purpura,
tissue disorders
Urticaria             Angioedema, Acute generalized exanthematous pustulosis (AGEP)
Elevation in AST, ALT transaminases.
Investigations
Elevation in serum alkaline phosphatase
Ear and                                                               Transient deafness, Hypoacusia, labyrinth                                                             Vertigo, tinnitus disorders
Eye disorders                                                         Visual disturbances, blurred vision 
Prolongation of the QT interval.
Ventricular arrhythmia such as
Cardiovascular torsades de pointe or ventricular disorders tachycardia which may cause ventricular fibrillation or cardiac arrest (see section 4.4).

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/.