Summary of Product Characteristics
last updated on the eMC:
18/01/2012
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 18/01/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| 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
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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
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Pregnancy, puerperium and perinatal conditions
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Drug withdrawal syndrome neonatal (see 4.6)
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Updated on 29/04/2010 and displayed until 18/01/2012
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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Change to section 4.4 - Special warnings and precautions for Use
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| 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
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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.
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Updated on 17/11/2008 and displayed until 29/04/2010
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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