Summary of Product Characteristics
last updated on the eMC:
13/09/2011
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 13/09/2011 and displayed until Current
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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 4.5 - Interaction with other medicinal products and other forms of interaction
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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: 31-Aug-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4
INSERTED
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. Clozapine should be used with
caution in patients with risk factors for stroke.
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.
DENZAPINE
is not approved for the treatment of dementia-related behavioural disturbances.
Section 4.5
INSERTED TO THE TABLE
CYP1A2
inducing substances (e.g. omeprazole) Concomitant use may decrease clozapine
levels Potential for reduced efficacy of clozapine should be considered.
CYP1A2 inhibiting substances (e.g. fluvoxamine, caffeine, ciprofloxacin)
Concomitant use may increase clozapine levels Potential for increase in adverse
effects. Care is also required upon cessation of concomitant CYP1A2 inhibiting
medications as there will be a decrease in clozapine levels.
Section 4.8
INSERTED
Very rare events of ventricular tachycardia and QT prolongation which may be associated
with Torsades De Pointes have been observed although there is no conclusive
causal relationship to the use of this medicine
Common Dysarthria
Uncommon Dysphemia
Very Rare Obsessive compulsive disorder
Rare pneumonia and lower respiratory tract infection which may be fatal
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Updated on 15/06/2010 and displayed until 13/09/2011
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Extra statutory information
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| Date of revision of text on the SPC: 08-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 1: the addition of the monitoring requirements for all Denzapine patients across all strengths.
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Updated on 08/03/2010 and displayed until 15/06/2010
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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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| Date of revision of text on the SPC: 23-Feb-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Addition to 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 DENZAPINE and preventive measures undertaken
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Updated on 14/05/2009 and displayed until 08/03/2010
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Reasons for adding or updating:
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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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