Adverse reactions : תופעות לוואי

4.8. Undesirable effects
At low doses
- Autonomic disturbances:

- postural hypotension,
- anticholinergic effects such as dry mouth, constipation, even paralytic ileus (see Section 4.4), visual accommodation disorders, risk of urinary retention (see Section 4.4).

- Neuropsychiatric disorders:

- sedation or drowsiness, more pronounced at the beginning of treatment, - indifference, anxiety reactions, mood changes.

- At higher doses

- Neuropsychiatric disorders:
- early-onset dyskinesia (spasmodic torticollis, oculogyric crises, trismus, etc.).
- extrapyramidal syndrome: o akinetic symptoms with or without hypertonia, partially resolving with anticholinergic antiparkinsonian agents,
o hyperkinetic-hypertonic and excitatory motor activity,
o akathisia
- tardive dyskinesia, occurring particularly during long-term treatment. It may sometimes occur after the neuroleptic agent is withdrawn and resolve after rechallenge or if dosage is increased.

- Anticholinergic antiparkinsonians have no effect and may cause exacerbation.

- Autonomic disturbances:
- anticholinergic effects: very rare cases of potentially fatal necrotizing enterocolitis have been reported (see Section 4.4).

- Endocrine and metabolic disorders:

-   hyperprolactinemia: amenorrhea, galactorrhea, gynecomastia, impotence, frigidity, -   thermoregulation disorders,
-   weight gain,
-   hyperglycemia, impaired glucose tolerance. (see section 4.4)

- Dose-dependent and rarely reported

- Cardiac disorders:
- QT interval prolongation,
- very rare cases of torsades de pointes have been reported.

- Non-dose-dependent and more rarely reported

- Skin disorders:
- allergic skin reactions,
- photosensitization.

- Blood disorders:

- exceptional cases of agranulocytosis: regular differential leukocyte counts are recommended, - leukopenia.

- Eye disorders:

- brownish deposits in the anterior segment of the eye caused by accumulation of the drug and generally without effect on vision.

- Other disorders:

-   positive titer for antinuclear antibodies in patients who do not have clinical lupus erythematosus, -   neuroleptic malignant syndrome (see Section 4.4),
-   possible cholestatic jaundice,
-   very rare cases of priapism.

In addition, isolated cases of sudden death of cardiac origin and unexplained sudden death have been reported in patients treated with phenothiazine, butyrophenone or benzamide antipsychotic neuroleptics (see Section 4.4).

Cases of venous thromboembolism, including cases of pulmonary embolism and deep vein thrombosis, have been reported with antipsychotics - unknown frequency (see Section 4.4).

Additional adverse events reported:
Nervous system disorders: Confusional states, delirium, convulsions
Hepatobiliary disorders: Hepatocellular, cholestatic and mixed liver injury.
Metabolism and nutrition disorders: hyponatraemia, syndrome of inappropriate antidiuretic hormone secretion (SIADH).