Adverse reactions : תופעות לוואי

4.8   Undesirable effects
The majority of undesirable effects are dose dependent. The frequency and severity are most pronounced in the early phase of treatment and decline during continued treatment.
Extrapyramidal reactions may occur, especially in the early phase of treatment. In most cases these side effects can be satisfactorily controlled by reduction of dosage and/or use of antiparkinsonian drugs. The routine prophylactic use of antiparkinsonian drugs is not recommended.
Antiparkinsonian drugs do not alleviate tardive dyskinsea and may aggravate them.
Reduction in dosage or, if possible, discontinuation of zuclopenthixol therapy is recommended. In persistent akathisia a benzodiazepine or propranolol may be useful.

Frequencies are taken from the literature and spontaneous reporting. Frequencies are defined as: very common (1/10), common (1/100 to <1/10), uncommon (1/1000 to <1/100), rare (1/10000 to <1/1000), very rare (<1/10000), or not known (can not be estimated from the available data).
Blood and lymphatic system           Rare       Thrombocytopenia, neutropenia, disorders                                       leukopenia, agranulocytosis.


Immune system disorders              Rare       Hypersensitivity, anaphylactic reaction.

Endocrine disorders                  Rare       Hyperprolactinaem ia.
Metabolism and nutrition disorders   Common     Increased appetite, weight increased .
Uncommon   Decreased appetite, weight decreased.
Rare       Hyperglycaemia,
glucose tolerance impaired,
hyperlipidaemia.

Psychiatric disorders                Common     Insomnia,
depression,
anxiety,
nervousness,
abnormal dreams,
agitation, libido decreased.
Uncommon   Apathy, nightmare,
libido increased,
confusional state.

Nervous system disorders             Very       Somnolence,
common     akathisia,
hyperkinesia,
hypokinesia.
Common     Tremor, dystonia, hypertonia, dizziness,
headache, paraesthesia, disturbance in attention, amnesia, gait abnormal.
Uncommon    Tardive dyskinesia, hyperreflexia,
dyskinesia, parkinsonism, syncope, ataxia,
speech disorder, hypotonia, convulsion,
migraine.
Very rare   Neuroleptic malignant syndrome.
Eye disorders                 Common      Accommodation disorder, vision abnormal.

Uncommon    Oculogyration, mydriasis.
Ear and labyrinth disorders   Common      Vertigo.
Uncommon    Hyperacusis, tinnitus.
Cardiac disorders             Common      Tachycardia, palpitations.
Rare        Electrocardiogram QT prolonged.
Vascular disorders            Uncommon    Hypotension, hot flush.
Very rare   Venous thromboembolism
Respiratory, thoracic         Common      Nasal congestion, dyspnoea.
and medistianal disorders

Gastrointestinal disorders    Very common Dry mouth.
Common      Salivary hypersecretion, constipation,
vomiting, dyspepsia, diarrhoea.
Uncommon    Abdominal pain, nausea, flatulence.
Hepato-biliary disorders      Uncommon    Liver function test abnormal.
Very rare   Cholestatic hepatitis, jaundice.
Skin and subcutaneous         Common      Hyperhidrosis, pruritus.
tissue disorders
Uncommon    Rash, photosensitivity reaction,
pigmentation disorder, seborrhoea,
dermatitis, purpura.
Musculoskeletal and           Common      Myalgia.
connective tissue disorder
Uncommon    Muscle rigidity, trismus, torticollis.
Renal and urinary disorders   Common      Micturition disorder, urinary retention, polyuria.
Pregnancy, puerperium         Not         Drug withdrawal syndrome neonatal (see and perinatal conditions      known       4.6)
Reproductive system and       Uncommon    Ejaculation failure, erectile dysfunction, breast disorders                          female orgasmic disorder, vulvovaginal dryness.
Rare        Gynaecomastia, galactorrhoea,
amenorrhoea, priapism.
General disorders and         Common      Asthenia, fatigue, malaise, pain.
administration site
Uncommon    Thirst, injection site reaction, hypothermia,
conditions pyrexia.
As with other drugs belonging to the therapeutic class of antipsychotics, rare cases of QT prolongation, ventricular arrhythmias - ventricular fibrillation, ventricular tachycardia, Torsade de Pointes and sudden unexplained death have been reported for zuclopenthixol (see section 4.4).
Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs – Frequency unknown.
Abrupt discontinuation of zuclopenthixol may be accompanied by withdrawal symptoms. The most common symptoms are nausea, vomiting, anorexia, diarrhoea, rhinorrhoea, sweating, myalgias, paraesthesias, insomnia, restlessness, anxiety, and agitation. Patients may also experience vertigo, alternate feelings of warmth and coldness, and tremor. Symptoms generally begin within 1 to 4 days of withdrawal and abate within 7 to 14 days.

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/