Adverse reactions : תופעות לוואי

4.8   Undesirable effects
The most frequently reported adverse events are dry mouth, somnolence, akathisia, hyperkinesia or hypokinesia, which are seen in more than 10% of the patients treated.


The adverse events are mostly dose dependent. The frequency and severity of the undesirable effects are most pronounced in the early phase of treatment and decline during continued treatment.

Extrapyramidal disorders may occur, especially during the early phase of treatment. In most cases these adverse events can be satisfactorily controlled by reduction of dosage and/or by using antiparkinsonian drugs. The routine prophylactic use of antiparkinsonian drugs is not recommended.
Antiparkinsonian drugs do not alleviate tardive dyskinesia, but may aggravate the symptoms. A dose reduction is recommended or, if possible, a discontinuation of the treatment. In persistent akathisia a benzodiazepine or propranolol may be useful.


Blood and lymphatic system disorders
Rare (≥1/10,000 to ≤1/1,000)                         Thrombocytopenia, neutropenia, leukopenia, agranulocytosis.

Immune system disorders
Rare (≥1/10,000 to ≤1/1,000)                         Hypersensitivity, anaphylactic reaction.

Endocrine disorders
Rare (≥1/10,000 to ≤1/1,000)                         Hyperprolactinaemia.
Metabolism and nutrition disorders
Common (≥1/100 to <1/10)                             Increased appetite, weight increase.

Uncommon (≥1/1,000 to ≤1/100)                        Decreased appetite, weight loss.

Rare (≥1/10,000 to ≤1/1,000)                         Hyperglycaemia, abnormal glucose tolerance, hyperlipidaemia.

Psychiatric disorders
Common (≥1/100 to <1/10)                             Insomnia, depression, anxiety, nervousness, abnormal dreams, agitation, decreased libido.

Uncommon (≥1/1,000 to ≤1/100)                        Apathy, nightmares, increased libido, confusion.

Nervous system disorders
Very common (≥1/10)                                  Somnolence, akathisia, hyperkinesia, hypokinesia.

Common (≥1/100 to <1/10)                             Tremor, dystonia, hypertonia, dizziness, headache, paraesthesia, impaired concentration,
amnesia, abnormal gait.

Uncommon (≥1/1,000 to ≤1/100)                        Tardive dyskinesia, hyperreflexia, dyskinesia, parkinsonism, syncope, ataxia, speech disturbances, hypotonia, convulsions, migraine.

Very rare (≤1/10,000)                                Neuroleptic malignant syndrome.

Eye disorders
Common (≥1/100 to <1/10)                             Abnormalities of visual accommodation, visual disturbances.

Uncommon (≥1/1,000 to ≤1/100)                        Oculogyration, mydriasis.

Ear and labyrinth disorders
Common (≥1/100 to <1/10)                             Dizziness.
Uncommon (≥1/1,000 to ≤1/100)               Hyperacusis, tinnitus.

Cardiac disorders
Common (≥1/100 to <1/10)                    Tachycardia, palpitation.

Rare (≥1/10,000 to ≤1/1,000)                QT prolongation.
Vascular disorders
Uncommon (≥1/1,000 to ≤1/100)               Hypotension, hot flushes.

Very rare (≤1/10,000)                       Venous thromboembolism

Respiratory, thoracic and mediastinal disorders
Common (≥1/100 to <1/10)                    Blocked nose, dyspnoea.
Gastrointestinal disorders
Very common (≥1/10)                         Dry mouth.

Common (≥1/100 to <1/10)                    Increased salivation, constipation, vomiting, dyspepsia, diarrhoea.

Uncommon (≥1/1,000 to ≤1/100)               Abdominal pain, nausea, flatulence.

Hepatobiliary disorders
Uncommon (≥1/1,000 to ≤1/100)               Altered liver tests.
Very rare (≤1/10,000)                       Cholestatic hepatitis, jaundice.

Skin and subcutaneous tissue disorders
Common (≥1/100 to <1/10)                    Excessive sweating, pruritus.

Uncommon (≥1/1,000 to ≤1/100)               Rash, photosensitivity, pigmentary disturbances, seborrhoea, dermatitis, purpura.

Musculoskeletal and connective tissue disorders
Common (≥1/100 to <1/10)                    Myalgia.

Uncommon (≥1/1,000 to ≤1/100)               Muscle rigidity, trismus, torticollis.
Renal and urinary disorders
Common (≥1/100 to <1/10)                    Urinary disturbances, urinary retention, polyuria.

Pregnancy, puerperium and perinatal conditions
Not known                                   Drug withdrawal syndrome neonatal (see 4.6) 
Reproductive system and breast disorders
Uncommon (≥1/1,000 to ≤1/100)               Ejaculatory and erectile dysfunction, anorgasmia (women), vulvar and vaginal dryness.

Rare (≥1/10,000 to ≤1/1,000)                Gynaecomastia, galactorrhoea, amenorrhoea, priapism.

General disorders and administration site
conditions
Common (≥1/100 to <1/10)                                Asthenia, fatigue, discomfort, pain.

Uncommon (≥1/1,000 to ≤1/100)                           Thirst, hypothermia, fever.

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).

Abrupt discontinuation of zuclopenthixol may lead to withdrawal symptoms. The most common reactions are nausea, vomiting, anorexia, diarrhoea, rhinorrhoea, sweating, myalgia, paraesthesia, insomnia, restlessness, anxiety and agitation. Patients may also experience vertigo, may feel warm/cold, respectively, and experience tremor. The symptoms usually set in 1-4 days after discontinuation and subside during 1-2 weeks.

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/