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 12/04/2010 and displayed until 15/06/2010
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 15-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Addition of the following text into section 4.8
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 25/08/2009 and displayed until 12/04/2010
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Reasons for adding or updating:
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Joint SPC superseded by SPCs for individual presentations
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| Date of revision of text on the SPC: 28-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Combined 25, 50, 100 and 200mg tablet SmPC
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Updated on 11/06/2009 and displayed until 25/08/2009
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 3 - Pharmaceutical form
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Change to section 6.1 - List of Excipients
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 01-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In Section 2. The details of the 25 and 100mg tablets have been separated, and lactose quantity added.
in Section 3. The details of the 25 and 100mg tablets have been expanded and separated.
In Section 6.1 Sodium Starch Glycollate has been changed to sodium starch glycollate A
In Section 6.4 Addition of "to protect from light"
In Section 6.5 Addition of "Not all pack sizes are marketed"
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Updated on 03/03/2008 and displayed until 11/06/2009
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Reasons for adding or updating:
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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: 07/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 10: Change in date of revision from 19th January 2007 to 19th July 2007.
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Updated on 14/02/2008 and displayed until 03/03/2008
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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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