Adverse reactions : תופעות לוואי

4.8    Undesirable Effects

System/organ
Reactions categories
Very common           Common       Uncommon            Rare             Very rare           Unknown (>1/10)           (<1/10 but    (<1/100 but     (<1/1,000 but       (<1/10,000) >1/100)       (≥1/1,000)      (≥1/10,000)

Blood &                                                                                Leukopaenia, lymphatic                                                                              Neutropenia system disorders

Immune system                                                                          Hypersensitivity disorders

Metabolism and                       Decreased                                         Dehydration          Increased nutrition                            appetite                                                               appetite disorders

Psychiatric      Depression,         Irritability,                                     Aggression, disorders        Anxiety,            Obsessive-                                        Anger, Suicidal Restlessness,       compulsive                                        ideation, Suicide Confusion           disorder,                                         attempt, Agitation;                                        Nervousness,
Sleep disorder

Nervous system    Sedation/          Parkinsonism                                      Neuroleptic       Memory loss disorders         Somnolence/        (may include                                      Malignant Drowsiness,        balancing
Extrapyramidal     problems),                                        Syndrome, event,             Gait imbalance/                                   Ataxia, Tremor, Insomnia,          balance                                           Excess salivation Akathisia          difficulty,
Bradykinesia,
Dystonia,
Lethargy,
Dizziness,
Dysarthria,
Headache

Eye disorders    Blepharospasm                                                         Oculogyric crisis, Photophobia

Cardiac                                                                                Palpitations disorders

Vascular                                                                               Hypertension         Postural disorders                                                                                                   hypotension, Hypertensive crisis

Respiratory,     Upper               Pneumonia,                                        Cough, thoracic and     respiratory tract   Dyspnoea,                                         Pneumonia mediastinal      infection           Bronchitis                                        aspiration disorders

Gastro-          Nausea              Diarrhoea,                       Dysphagia        Dry mouth intestinal                           Vomiting,
disorders                            Constipation


Heptaobiliary                                                                                      Increased disorders                                                                                          ALT, Increased
AST

Skin &                                                                         Hyperhidrosis, subcutaneous                                                                   Rash, Pruritus, tissue disorders                                                               Urticaria 

Renal and                           Dysuria                                    Urinary tract urinary                                                                        infection disorders

Reproductive                                                                   Irregular system and                                                                     menstrual breast                                                                         cycle/amenorrhea/ disorders                                                                      menstrual disorders

General              Fatigue        Ecchymosis                                 Malaise, Pyrexia,   Weakness disorders and                                                                  Drug interaction administration site conditions


Investigations                                                                 Weight decreased Weight increased 
Injury,              Fall           Laceration,                  Drug           Overdose poisoning and                       Inflicted injury             administration procedural                                                       error complications



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/ and emailed to the Registration Holder’s Patient Safety Unit at: drugsafety@neopharmgroup.com