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 dyskinesia and may aggravate it.
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                   Rare             Thrombocytopenia, neutropenia, lymphatic system                             leukopenia, agranulocytosis.
disorders
Immune system               Rare             Hypersensitivity, anaphylactic reaction.
disorders
Endocrine disorders         Rare             Hyperprolactinaemia.
Metabolism and              Common           Increased appetite, weight increased.
nutrition
Uncommon         Decreased appetite, weight decreased.
disorders
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             Very              Somnolence, akathisia, hyperkinesia, disorders                  common            hypokinesia.
Common       Tremor, dystonia, hypertonia, dizziness,
headache, paraesthesia, disturbance in attention,
amnesia, gait abnormal.
Uncommon     Tardive dyskinesia, hyperreflexia,
to Rare      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      Common       Vertigo.
disorders
Uncommon     Hyperacusis, tinnitus.
Cardiac disorders      Common       Tachycardia, palpitations.
Rare         Electrocardiogram QT prolonged.
Vascular disorders     Uncommon      Hypotension, hot flush.
Very rare     Venous thromboembolism
Respiratory,           Common        Nasal congestion, dyspnoea.
thoracic and medistianal disorders
Gastrointestinal      Very common    Dry mouth.
disorders
Common         Salivary hypersecretion, constipation,
vomiting, dyspepsia, diarrhoea.
Uncommon       Abdominal pain, nausea, flatulence.
Hepato-biliary        Uncommon       Liver function test abnormal.
disorders             Very rare      Cholestatic hepatitis, jaundice.
Skin and              Common         Hyperhidrosis, pruritus.
subcutaneous tissue   Uncommon       Rash, photosensitivity reaction, disorders pigmentation disorder, seborrhoea,
dermatitis, purpura.
Musculoskeletal and   Common         Myalgia.
connective tissue     Uncommon       Muscle rigidity, trismus, torticollis.
disorder
Renal and urinary     Common         Micturition disorder, urinary retention, disorders                            polyuria.
Pregnancy,            Not known      Drug withdrawal syndrome neonatal (see puerperium and                       4.6) perinatal conditions
Reproductive          Uncommon       Ejaculation failure, erectile dysfunction, female system and                           orgasmic disorder, vulvovaginal dryness.
breast disorders             Rare           Gynaecomastia, galactorrhoea, amenorrhoea, priapism.
General disorders     Common         Asthenia, fatigue, malaise, pain.
and administration         Uncommon           Thirst, injection site reaction, site conditions                               hypothermia, 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/