Clopixol Tablets
- Name:
Clopixol Tablets
- Company:
Lundbeck (Ireland) Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/09/20
(Click to Download)XPIL
PACKAGE LEAFLET: INFORMATION FOR THE USER
PACKAGE LEAFLET: INFORMATION FOR THE USER
1. What Clopixol is and what it is used for
1. What Clopixol is and what it is used for
2. What you need to know before you take Clopixol
2. What you need to know before you take Clopixol
3. How to take Clopixol
3. How to take Clopixol
4. Possible side effects
4. Possible side effects
5. How to store Clopixol
5. How to store Clopixol
6. Contents of the pack and other information
6. Contents of the pack and other information
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Lundbeck (Ireland) Limited
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Company Products
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 15 September 2020
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Updated on 15 September 2020 PIL
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation number
Updated on 9 April 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 9 April 2019
Reasons for updating
- Change to section 7 - Marketing authorisation holder
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
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 SPC
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
Updated on 30 June 2015 SPC
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
Updated on 30 June 2015 PIL
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 5 May 2015 SPC
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
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 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 3 January 2015 SPC
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
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 PIL
Reasons for updating
- Discontinuation of one or more strengths
Updated on 26 June 2013 SPC
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
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 SPC
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 SPC
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
Updated on 10 December 2010 PIL
Reasons for updating
- Introduction of new pack/pack size
Updated on 13 August 2010 SPC
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
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 SPC
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 SPC
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
Correction to spelling of mediastinal
Updated on 23 August 2009 SPC
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
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 SPC
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 SPC
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
Updated on 12 August 2008 SPC
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 SPC
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
Date of first authorisation: and Date of last renewal: have been entered
Updated on 23 August 2007 SPC
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
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 SPC
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 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)