Summary of Product Characteristics Updated 15-Oct-2020 | Lundbeck Limited
Excipients with known effect:Lactose monohydrate Hydrogenated castor oil.For the full list of excipients, see section 6.1
AdultsThe dosage range is 4-150 mg/day in divided doses. The usual initial dose is 20-30 mg/day (sometimes with higher dosage requirements in acute cases), increasing as necessary. The usual maintenance dose is 20-50 mg/day.Maximum dosage per single dose is 40 mg.When transferring patients from oral to depot antipsychotic treatment, the oral medication should not be discontinued immediately, but gradually withdrawn over a period of several days after administering the first injection.
Older patientsIn accordance with standard medical practice, initial dosage may need to be reduced to a quarter or half the normal starting dose in the frail or older patients.
Paediatic populationClopixol is not indicated for use in children due to lack of clinical experience.
Patients with renal impairmentClopixol can be given in usual doses to patients with reduced renal function. Where there is renal failure dosage should be reduced to half the normal dosage.
Patients with hepatic impairmentUse with caution in patients with liver disease (see section 4.4). Patients with compromised hepatic function should receive half the recommended dosages. Serum-level monitoring is advised
Method of administrationThe tablets are swallowed with water.
Treatment:Discontinuation of the neuroleptic. Symptomatic treatment and use of general supportive measures. Dantrolene and bromocriptine may be helpful. Symptoms may persist for more than a week after oral neuroleptics are discontinued and somewhat longer when associated with the depot forms of the drugs.Like other neuroleptics, zuclopenthixol should be used with caution in patients with organic brain syndrome, convulsions or advanced hepatic disease.Blood dyscrasias have been reported rarely. Blood counts should be carried out if a patient develops signs of persistent infection.As with other drugs belonging to the therapeutic class of antipsychotics, zuclopenthixol may cause QT prolongation. Persistently prolonged QT intervals may increase the risk of malignant arrhythmias. Therefore, zuclopenthixol should be used with caution in susceptible individuals (with hypokalaemia, hypomagnesaemia or genetic predisposition) and in patients with a history of cardiovascular disorders, e.g. QT prolongation, significant bradycardia (<50 beats per minute), a recent acute myocardial infarction, uncompensated heart failure, or cardiac arrhythmia.Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with zuclopenthixol and preventive measures undertaken.Concomitant treatment with other antipsychotics should be avoided (see section 4.5).As described for other psychotropics, zuclopenthixol may modify insulin and glucose responses calling for adjustment of the antidiabetic therapy in diabetic patients.
Older peopleOlder people require close supervision because they are especially prone to experience such adverse effects as sedation, hypotension, confusion, and temperature changes.
CerebrovascularAn approximately 3-fold increased risk of cerebrovascular adverse events has been seen in randomised placebo controlled clinical trials in the dementia population with some atypical antipsychotics. The mechanism for this increased risk is not known. An increased risk cannot be excluded for other antipsychotics or other patient populations.Zuclopenthixol should be used with caution in patients with risk factors for stroke.
Increased Mortality in Older People with DementiaData from two large observational studies showed that older people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated.There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known.Clopixol tablets are not licensed for the treatment of dementia-related behavioural disturbances.
The tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.This medicinal product contains hydrogenated castor oil, which may cause stomach upset and diarrhoea.
PregnancyZuclopenthixol should not be administered during pregnancy unless the expected benefit to the patient outweighs the theoretical risk to the foetus.Neonates exposed to antipsychotics (including zuclopenthixol) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.Animal studies have shown reproductive toxicity (see section 5.3).
Breast-feedingAs zuclopenthixol is found in breast milk in low concentrations it is not likely to affect the infant when therapeutic doses are used. The dose ingested by the infant is less than 1% of the weight related maternal dose (in mg/kg). Breast-feeding can be continued during zuclopenthixol therapy if considered of clinical importance, but observation of the infant is recommended, particularly in the first 4 weeks after giving birth.
FertilityIn humans, adverse events such as hyperprolactinaemia, galactorrhoea, amenorrhoea, erectile dysfunction and ejaculation failure have been reported (see section 4.8). These events may have a negative impact on female and/or male sexual function and fertility.If clinically significant hyperprolactinaemia, galactorrhoea, amenorrhoea or sexual dysfunctions occur, a dose reduction (if possible) or discontinuation should be considered. The effects are reversible on discontinuation.Administration of zuclopenthixol to male and female rats was associated with a slight delay in mating. In an experiment where zuclopenthixol was administered via the diet, impaired mating performance and reduced conception rate was noted.
|Blood and lymphatic system disorders||Thrombocytopenia, neutropenia, leukopenia, agranulocytosis.|
|Immune system disorders||Hypersensitivity, anaphylactic reaction.|
|Metabolism and nutrition disorders||Increased appetite, weight increased.|
|Decreased appetite, weight decreased.|
|Hyperglycaemia, glucose tolerance impaired, hyperlipidaemia.|
|Psychiatric disorders||Insomnia, depression, anxiety, nervousness, abnormal dreams, agitation, libido decreased.|
|Apathy, nightmare, libido increased, confusional state.|
|Nervous system disorders||Somnolence, akathisia, hyperkinesia, hypokinesia.|
|Tremor, dystonia, hypertonia, dizziness, headache, paraesthesia, disturbance in attention, amnesia, gait abnormal.|
|Tardive dyskinesia, hyperreflexia, dyskinesia, parkinsonism, syncope, ataxia, speech disorder, hypotonia, convulsion, migraine.|
|Neuroleptic malignant syndrome.|
|Eye disorders||Accommodation disorder, vision abnormal.|
|Ear and labyrinth disorders||Vertigo.|
|Cardiac disorders||Tachycardia, palpitations.|
|Electrocardiogram QT prolonged.|
|Vascular disorders||Hypotension, hot flush.|
|Respiratory, thoracic and mediastinal disorders||Nasal congestion, dyspnoea.|
|Gastrointestinal disorders||Dry mouth.|
|Salivary hypersecretion, constipation, vomiting, dyspepsia, diarrhoea.|
|Abdominal pain, nausea, flatulence.|
|Hepato-biliary disorders||Liver function test abnormal.|
|Cholestatic hepatitis, jaundice.|
|Skin and subcutaneous tissue disorders||Hyperhidrosis, pruritus.|
|Rash, photosensitivity reaction, pigmentation disorder, seborrhoea, dermatitis, purpura.|
|Musculoskeletal and connective tissue disorder||Myalgia.|
|Muscle rigidity, trismus, torticollis.|
|Renal and urinary disorders||Micturition disorder, urinary retention, polyuria.|
|Pregnancy, puerperium and perinatal conditions||Drug withdrawal syndrome neonatal (see 4.6)|
|Reproductive system and breast disorders||Ejaculation failure, erectile dysfunction, female orgasmic disorder, vulvovaginal dryness.|
|Gynaecomastia, galactorrhoea, amenorrhoea, priapism.|
|General disorders and administration site conditions||Asthenia, fatigue, malaise, pain.|
|Thirst, hypothermia, pyrexia.|
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Pharmacotherapeutic group: Neuroleptics (antipsychotics), ATC code: N05AF05
Mechanism of action
The action of zuclopenthixol, as with other antipsychotics is mediated through dopamine receptor blockage.
Zuclopenthixol has a high affinity for D1 and D2 receptors and activity has been demonstrated in standard animal models used to assess antipsychotic action. Serotonergic blocking properties, a high affinity for alpha-adrenoreceptors and slight antihistamine properties have been observed.
Reproductive toxicityImpaired mating performance and reduced conception rates were observed in rats treated with zuclopenthixol at doses equal to the maximum recommend human dose of 50 mg on a mg/m2 basis.There was no evidence of embryotoxicity or teratogenic effects in rats treated with zuclopenthixol, however adverse effects on pre-and postnatal development (i.e. increased stillbirths, reduced pup survival and delayed development of pups) was observed. The clinical significance of these findings is unclear and it is possible that the effect on pups was due to neglect from the dams that were exposed to doses of zuclopenthixol producing maternal toxicity.
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2 mg tablets:
10 mg tablets:
25 mg tablets:
|Date of First Authorisation in the UK: Renewal of the Authorisation:||17 March 1982 3 July 2008|
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