Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Autonomic: Particularly during the first few days of treatment, Orthostatic hypotension which may cause syncope in elderly individuals.
Atropine-like effects: dry mouth, constipation, accommodation disturbances.


Neurological:
Effects on the CNS, comprising sedation, agitation and states of confusion, are rare.
Extrapyramidal disorders, such as dystonia, akathisia (fear of sitting down) and pseudoparkinsonism are usually mild and can easily be controlled by antiparkinson agents.
Rare but sometimes irreversible tardive dyskinesias may be observed during prolonged courses of treatment.
Neuroleptic malignant syndrome (catatonia, obnubilation; akinesia, rigidity, opisthotonus, dysregulation of the autonomic nervous system, hyperpyrexia) may occur in the first few days of treatment when treatment is combined with another medicinal product or when the dosage is increased.

Eye: Blurred vision (uncommon).

Miscellaneous:
Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis, have been reported with antipsychotic medications – Frequency not known.
Very rare cases of QT interval prolongation, which might be associated with torsades de pointes, have been observed, although a causal link with the use of Entumin cannot be conclusively demonstrated. Cases of leukopenia/neutropenia have been reported in temporal relationship with antipsychotics. Cases of agranulocytosis have also been reported.
Hyperkinesia, EEG changes, oedema, rash, hyperpyrexia, sweating, acute pancreatitis, thrombocytopenia, gastroenteritis, paralytic ileus: isolated cases, with a possible relationship with Entumin, have been observed.

Pregnancy, puerperium and perinatal conditions:
Frequency not known: neonatal drug withdrawal syndrome.

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