Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Adverse reactions are presented according to the MedDRA system organ classes and MedDRA frequency convention: 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).

Blood and lymphatic system disorders
Uncommon: leukopenia (see section 4.4)
Not known: neutropenia, agranulocytosis (see section 4.4)

Immune system disorders
Not known: anaphylactic reactions; urticaria, dyspnoea, hypotension and anaphylactic shock

Metabolism and nutrition disorders
Not known: Hyponatremia, Syndrome of inappropriate antidiuretic hormone secretion (SIADH)

Endocrine disorders
Common: hyperprolactinaemia

Psychiatric disorders
Common: insomnia
Not known: confusion
Nervous system disorders
Common: sedation or somnolence, extrapyramidal symptoms, parkinsonism, tremor, akathisia
Uncommon: hypertonia, dyskinesia, dystonia
Rare: oculogyric crisis
Not known: neuroleptic malignant syndrome, hypokinesia, tardive dyskinesia (characterized by rhythmic and involuntary movements mainly of the tongue and/or face, has been reported, as with all neuroleptics, after a neuroleptic administration of more than 3 months. Antiparkinsonian medication is ineffective or may induce aggravation of the symptoms). As with all neuroleptics, the neuroleptic malignant syndrome (see section 4.4) is a life-threatening complication), convulsion.

Cardiac disorders (see section 4.4)
Rare: ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia Not known: QT prolongation on electrocardiogram, cardiac arrest, torsade de pointes, and sudden death.


Vascular disorders (see section 4.4)
Uncommon: orthostatic hypotension
Not known: venous embolism, pulmonary embolism, deep vein thrombosis.
Respiratory, thoracic and mediastinal disorders
Not known: pneumonia aspiration (mainly in association with other CNS depresants) 
Gastrointestinal disorders
Common: constipation
Uncommon: salivary hypersecretion

Hepatobiliary disorders
Common: Increase in liver enzymes
Not known: Hepatocellular, cholestatic or mixed liver injury
Skin and subcutaneous tissue disorders
Common: maculo-papular rash

Musculoskeletal and connective tissue disorders
Not known: torticollis, trismus, rhabdomyolysis

Pregnancy, puerperium and perinatal conditions (see section 4.6) Not known: extrapyramidal symptoms, withdrawal syndrome in neonates (see section 4.6)

Reproductive system and breast disorders
Common: breast pain, galactorrhoea
Uncommon: breast enlargement, amenorrhoea, abnormal orgasm, erectile dysfunction.
Not known: gynaecomastia

General disorders and alterations at the site of administration Common: weight gain
Not Known: hyperthermia (see section 4.4)
Investigations:
Not known: blood creatine phosphokinase increased

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/