Clopixol Tablets

  • Name:

    Clopixol Tablets

  • Company:
    info
  • Active Ingredients:

    Zuclopenthixol dihydrochloride

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/04/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 9/4/2019

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Lundbeck (Ireland) Limited

Lundbeck (Ireland) Limited

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Medicine Name Clopixol Conc. Injection 500 mg/ml Active Ingredients Zuclopenthixol decanoate
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Medicine Name Clopixol Tablets Active Ingredients Zuclopenthixol dihydrochloride
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1 - 0 of 25 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 9 April 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 9 April 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 2 March 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 March 2017 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 8 February 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 8 February 2017 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to address of office of Marketing Authorisation holder

Updated on 30 June 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 30 June 2015 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change in MAH contact details.

Updated on 5 May 2015 PIL

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 5 May 2015 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
  • Change to improve clarity and readability

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

QRD version 9.0 update and

Section 4.6 update:  
Pregnancy

Animal studies have shown reproductive toxicity (see section 5.3).

 

Fertility

In 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.

 

Animal studies have shown impaired mating and reduced conception rate (see section 5.3).

Section 5.3:

Reproductive toxicity

In a three-generation study in rats a delay in mating was noted. Once mated there was no effect on fertility. In an experiment where zuclopenthixol was administered via the diet, impaired mating performance and reduced conception rate was noted. 

 

Animal reproduction studies have not shown evidence of embryotoxic or teratogenic effects.

In a peri/postnatal study in rats, dosages of 5 and 15 mg/kg/day resulted in an increase of stillbirths, reduced pup survival and delayed development of pups.

 

 

Updated on 3 January 2015 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change in Storage conditions:

Store below 25C. Store in the original package...
 
to:

Store in the original package and keep the bottle tightly closed in order to protect from moisture.

This medicinal product does not require any special temperature storage conditions.

Updated on 12 September 2014 PIL

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 26 June 2013 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 8 - MA number

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In sections 1, 2, 3 and 8, references to the 25 mg strength have been removed.

Updated on 26 June 2013 PIL

Reasons for updating

  • Discontinuation of one or more strengths

Updated on 17 May 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to how the medicine works
  • Change to date of revision
  • Change to dosage and administration
  • Change due to user-testing of patient information
  • Correction of spelling/typing errors

Updated on 9 May 2012 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

New text in Section 4.6:

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.

New warning in Section 4.8:

Pregnancy, puerperium and perinatal conditions

Not known

Drug withdrawal syndrome neonatal (see 4.6)

Updated on 23 December 2010 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Addition of new HDPE container to Section 6.5

Updated on 10 December 2010 PIL

Reasons for updating

  • Introduction of new pack/pack size

Updated on 13 August 2010 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Inserted correct spelling to rhabdomyolysis and myogluninuria

Updated on 26 July 2010 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 12 July 2010 PIL

Reasons for updating

  • Change to side-effects

Updated on 9 July 2010 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4

 

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 dihydrochloride 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.

 

Zuclopenthixol dihydrochloride is not licensed for the treatment of dementia-related behavioural disturbances.

 

Section 4.8

 

Vascular disorders   Uncommon    Hypotension, hot flush.

                                       Very rare       Venous thromboembolism

Updated on 11 December 2009 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8

Correction to spelling of mediastinal

Updated on 23 August 2009 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Addition of hydrogenated castor oil

Section 2

10mg Tablet

Each tablet contains 10mg zuclopenthixol (as 11.82 mg zuclopenthixol dihydrochloride).

 

Excipients: Each tablet contains 21.6mg lactose monohydrate and 0.72 mg hydrogenated castor oil.

 

25mg Tablet

Each tablet contains 25 mg zuclopenthixol (as 29.55 mg zuclopenthixol dihydrochloride).

 

Excipients: Each tablet contains 22 mg lactose monohydrate and 0.96 mg hydrogenated castor oil.

 

For a full list of excipients, see section 6.1



Section 4.4

 Excipients

The tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not receive this medicine.

 

The tablets also contain hydrogenated castor oil which may cause stomach upset and diarrhoea.

Updated on 19 August 2009 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 16 March 2009 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Postcode changed from 8LF to 8LG
Sunningdale House changed to Lundbeck House

Updated on 17 December 2008 PIL

Reasons for updating

  • Change to storage instructions

Updated on 25 November 2008 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Core Text Updates applied to Sections 4.2 - 5.3

Updated on 12 August 2008 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 19 December 2007 PIL

Reasons for updating

  • Change of trade or active ingredient name

Updated on 1 December 2007 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 9 - Date of renewal of authorisation

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

1. 2mg, 10mg & 25mg placed before film-coated tablets
 
2.
Excipients: Each tablet contains 17.4 mg lactose monohydrate
Excipients: Each table contains 21.6 mg lactose monohydrate.
Excipients: Each tablet contains 22 mg lactose monohydrate.
 
For a full list of excipients, see section 6.1.
 
 
3. (Tablet) has been entered after film-coated tablet
 
4.

Date of first authorisation: and Date of last renewal: have been entered

Updated on 23 August 2007 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Shelf Life
Change Clopixol tablets 10mg & 25mg from 5 years to 2 years.

Updated on 25 September 2006 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 27 August 2006 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 13 April 2006 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 10 April 2006 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 14 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 25 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)