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Lundbeck Limited
Lundbeck House, Caldecotte Lake Business Park, Caldecotte, Milton Keynes, MK7 8LG
Telephone: +44 (0)1908 649 966
Fax: +44 (0)1908 647 888
WWW: http://www.lundbeck.co.uk
Medical Information Direct Line: +44 (0)1908 638 972
Medical Information e-mail: ukmedicalinformation@lundbeck.com
Customer Care direct line: +44 (0)1908 638 935

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 17/01/2012
SPC Clopixol Tablets 2, 10 and 25mg

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 17/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
As a consequence of the EMA PhVWP recommendations, the following changes have been made:

Section 4.6  Addition of the following text:  "Neonates exposed to antipsychotics (including Clopixol) 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."

Section 4.8 Addition of the following in the table of undesirable effects 

Pregnancy, puerperium and perinatal conditions

Drug withdrawal syndrome neonatal (see 4.6)
 
Updated on 10/05/2011 and displayed until 17/01/2012
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   01-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The previous SPC (28-1-2010) stated the following in section 6.5 Nature and contents of container:-

PackGrey polypropylene container (with desiccant capsule for 2 mg strength) or glass bottle. Contents: 100 tablets.

The latest SPC (1-10-2010) states the following in section 6.5 Nature and contents of container:-

Grey polypropylene container (with desiccant capsule for 2 mg strength) or glass
bottle.
or
Glass bottle
or
White HDPE container with LDPE twist-off cap including desiccant
Pack size: 100 tablets
Updated on 26/04/2010 and displayed until 10/05/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   28-Jan-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The changes to Sections 4.4 and 4.8 of the SPCs are to implement the changes required by the Pharmacovigilance Working Party (PhVWP) for antipsychotic drugs.

 

Section 4.4 Special warnings and precautions for use

 

Addition of:

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 Clopixol and preventive measures undertaken.

 

Increased Mortality in Elderly people with Dementia

Data from two large observational studies showed that elderly 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 is not licensed for the treatment of dementia-related behavioural disturbances.

Section 4.8 Undesirable effects
Addition of:

Cases of venous thromboembolism, including cases of pulmonary embolism

and cases of deep vein thrombosis have been reported with antipsychotic

drugs- Frequency unknown.

 
Updated on 24/11/2009 and displayed until 26/04/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   13-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 - addition of information on the maximum dosage per dose, and dosage information for hepatic and renally impaired patients.
Updated on 28/05/2009 and displayed until 24/11/2009
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   01-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


 

The changes affect Sections 3 of the SPC.

 

Section 3 PHARMACEUTICAL FORM:

 

Addition of:

 

Film-coated tablet

2 mg: Round, biconvex, pale red, film-coated tablet.

10 mg: Round, biconvex, light red-brown film-coated tablet.

25 mg: Round, biconvex, red-brown, film-coated tablet.

 

 

Deletion of:

Round, biconvex, pale red, film-coated tablets.

Updated on 02/12/2008 and displayed until 28/05/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   20-Nov-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 2 Qualitative and Quantitative Composition

Addition of:

Excipients:

Lactose, hydrogenated castor oil.

For a full list of excipients see section 6.1

 

Section 4.4 Special warnings and precautions for use

Additon of:

 

This medicinal product contains hydrogenated castor oil, which may cause stomach upset and diarrhoea.
Updated on 13/11/2008 and displayed until 02/12/2008
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   24-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.3 Contraindications

Amended to:

Hypersensitivity to the active substance or to any of the excipients (see section 6.1).

Circulatory collapse, depressed level of consciousness due to any cause (e.g. intoxication with alcohol, barbiturates or opiates), coma.

 

Section 4.4 Special warnings and precaution for use

Addition of:

The possibility of development of neuroleptic malignant syndrome (hyperthermia, muscle rigidity, fluctuating consciousness, instability of the autonomous nervous system) exists with any neuroleptic. The risk is possibly greater with the more potent agents. Patients with pre-existing organic brain syndrome, mental retardation and opiate and alcohol abuse are over-represented among fatal cases.

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 described for other psychotropics zuclopenthixol may modify insulin and glucose responses calling for adjustment of the antidiabetic therapy in diabetic patients.

  

Section 4.5 Interaction with other medicinal products and other forms of interaction

 

Sub-section related to co-administration and increase in QT interval amended to: Increases in the QT interval related to antipsychotic treatment may be exacerbated by the co administration of other drugs known to significantly increase the QT interval. Co-administration of such drugs should be avoided. Relevant classes include:

·        class Ia and III antiarrhythmics (e.g. quinidine, amiodarone, sotalol, dofetilide)

·        some antipsychotics (e.g. thioridazine)

·        some macrolides (e.g. erythromycin)

·        some antihistamines

·        some quinolone antibiotics (e.g. moxifloxacin)

 

The above list is not exhaustive and other individual drugs known to significantly increase QT interval (e.g. cisapride, lithium) should be avoided. Drugs known to cause electrolyte disturbances such as thiazide diuretics (hypokalemia) and drugs known to increase the plasma concentration of zuclopenthixol should also be used with caution as they may increase the risk of QT prolongation and malignant arrhythmias (see section 4.4).

 

Addition of: Since zuclopenthixol is partly metabolised by CYP2D6 concomitant use of drugs known to inhibit this enzyme may lead to higher than expected plasma concentrations of zuclopenthixol, increasing the risk of adverse effects and cardiotoxicity.

 

 

Section 4.8 Undesirable effects

 

Amended to: Undesirable effects are for the majority 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 them. Reduction in dosage or, if possible, discontinuation of zuclopenthixol therapy is recommended. In persistent akathisia a benzodiazepine or propranolol may be useful.

  

Cardiac disorders

Tachycardia, palpitations.

Electrocardiogram QT prolonged.

Blood and lymphatic system disorders

Thrombocytopenia, neutropenia, leukopenia, agranulocytosis.

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.

Oculogyration, mydriasis.

Ear and labyrinth disorders

Vertigo.

Hyperacusis, tinnitus.

Respiratory, thoracic and medistianal disorders

Nasal congestion, dyspnoea.

Gastrointestinal disorders

Dry mouth.

Salivary hypersecretion, constipation, vomiting, dyspepsia, diarrhoea.

Abdominal pain, nausea, flatulence.

Renal and urinary disorders

Micturition disorder, urinary retention, polyuria.

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.

Endocrine disorders

Hyperprolactinaemia.

Metabolism and nutrition disorders

Increased appetite, weight increased .

Decreased appetite, weight decreased.

Hyperglycaemia, glucose tolerance impaired, hyperlipidaemia.

Vascular disorders

Hypotension, hot flush.

General disorders and administration site conditions

Asthenia, fatigue, malaise, pain.

Thirst, hypothermia, pyrexia.

Injection site reaction

Immune system disorders

Hypersensitivity, anaphylactic reaction.

Hepato-biliary disorders

Liver function test abnormal.

Cholestatic hepatitis, jaundice.

Reproductive system and breast disorders

Ejaculation failure, erectile dysfunction, female orgasmic disorder, vulvovaginal dryness.

Gynaecomastia, galactorrhoea, amenorrhoea, priapism.

Psychiatric disorders

Insomnia, depression, anxiety, nervousness, abnormal dreams, agitation, libido decreased.

Apathy, nightmare, libido increased, confusional state.

 

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 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.

 

For further information contact:

Lundbeck Medical Information, email: ukmedicalinformation@lundbeck.com

Tel: 01908 638972.
Updated on 17/10/2008 and displayed until 13/11/2008
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   08-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.6 - addition of
Animal-reproduction studies have not given evidence of an increased incidence of foetal damage or other deleterious effects on the reproduction process.

Lactation

As 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.

Section 4.7 - general rewrite

Section 6.3 the shelf life for the 10mg and 25mg tablets has been changed from 5 years to 2 years

Section 6.5 - storage conditions for the 10 mg and 25 mg tablets has changed to do not store above 30 degC

 
Updated on 04/09/2007 and displayed until 17/10/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   08/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
  Specific changes are as follows:

Section 4.4: Addition of:  “An approximately 3-fold increased risk of cerebrovascular adverse events have 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.

 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, hypomagnesia 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.  Concomitant treatment with other antipsychotics should be avoided (see section 4.5).”

Section 4.5: Addition of: “Increases in the QT interval related to antipsychotic treatment may be exacerbated by the co‑administration of other drugs known to significantly increase the QT interval.  Co-administration of such drugs should be avoided.  Relevant classes include:

  • class Ia and III antiarrhythmics (e.g. quinidine, amiodarone, sotalol, dofetilide)
  • some antipsychotics (e.g. thioridazine)
  • some macrolides (e.g. erythromycin)
  • some antihistamines (e.g. terfenadine, astemizole)
  • some quinolone antibiotics (e.g. gatifloxacin, moxifloxacin)

The above list is not exhaustive and other individual drugs known to significantly increase QT interval (e.g. cisapride, lithium) should be avoided.

Drugs known to cause electrolyte disturbances such as thiazide diuretics (hypokalaemia) and drugs known to increase the plasma concentration of zuclopenthixol should also be used with caution as they may increase the risk of QT prolongation and malignant arrhythmias (see section 4.4).

Section 4.8: Addition of: “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 decanoate (see section 4.4).

Section 4.9, Addition of: “ECG changes, QT prolongation, Torsade de Pointes, cardiac arrest and ventricular arrhythmias have been reported when administered in overdose together with drugs known to affect the heart.
Updated on 12/02/2003 and displayed until 04/09/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
  • Correction of spelling/typing errors
Updated on 04/09/2002 and displayed until 12/02/2003
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 (date of (partial) revision of the text
Updated on 12/07/2001 and displayed until 04/09/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 06/09/1999 and displayed until 12/07/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  zuclopenthixol dihydrochloride