Summary of Product Characteristics
last updated on the eMC:
09/01/2012
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 09/01/2012 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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| Date of revision of text on the SPC: 07-Dec-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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- In section 4.6 - Fertility has been added to this section title and the section has been expanded.
Fertility, pregnancy and lactation
The safety of Anquil in pregnancy has not been established, although studies in
animals have not demonstrated teratogenic effects. As with other drugs, it is
not advisable to administer Anquil in pregnancy.
Neonates exposed to antipsychotics (including Anquil) 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,
hypotenia, tremor, somnolence, respiratory distress or feeding disorder.
Consequently, newborns should be monitored carefully.
Butyrophenones are excreted in breast milk and are not recommended during
lactation. If the use of Anquil is considered essential, breast feeding should be
discontinued.
- In section 4.8 - insert the following text (before the final section on Other adverse reactions)
................................................... and correction of hypoxia, electrolyte
abnormalities and acid base disturbances.
Pregnancy, puerperium and perinatal conditions
Drug withdrawal syndrome neonatal (see 4.6) (frequency not known).
Other adverse reactions
Jaundice or transient abnormalities of liver function in the absence of jaundice........
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Updated on 20/04/2010 and displayed until 09/01/2012
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Reasons for adding or updating:
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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: 08-Feb-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.4 (Special warnings and precautions for use) the following text has been moved:
"An 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. Benperidol should be used with caution in patients with risk factors for stroke.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine as it contains lactose.
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 Anquil and preventive measures undertaken."
For clarity this text no longer appears as the final three paragraphs of section 4.4 positioned after the text under the heading "Increased Mortality in Elderly people with Dementia" and just above the heading for section 4.5. The above text now appears under section 4.4 as the three paragraphs just above the heading "Increased Mortality in Elderly people with Dementia".
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Updated on 19/03/2010 and displayed until 20/04/2010
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 08-Feb-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - the following has been added:
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 Anquil and precentive 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 rish and the cause of the increased risk is not known.
Anquil is not licensed for the treatment of dementia-related behavioural disturbances.
Section 4.8 - the following has been added:
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 02/07/2009 and displayed until 19/03/2010
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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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