Summary of Product Characteristics
last updated on the eMC:
15/03/2012
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 15/03/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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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: 27-Jan-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.2 (Posology and method of administration) the heading of 'children' has been updated with paediatric population.
In section 4.6 (Fertility, pregnancy and lactation), a warning has been added regarding the use of antipsychotics during
pregnancy and risk of abnormal muscle movements and/or withdrawal symptoms in newborns.
4.8 (Undesirable effects) as in 4.6
Section 10 (Date of revision of the text) updated to 27-Jan-2012
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Updated on 05/10/2010 and displayed until 15/03/2012
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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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 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 5.2 - Pharmacokinetic Properties
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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: 20-Jul-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 4.3 (Contra-indications) the text has been updated to take account of use of other central nervous system depressants and patients with uncontrolled cardiac decompensation.
In section 4.4 (Special Warnings and Precautions for Use) the section now includes a warning for use in tardive dyskinesia and neuroleptic malignant syndrome. A precaution for regular and careful surveillance in patients on long term therapy has been added. A warning to discontinue the drug on an increase in pain has been added. There has also been an update for a precaution in bone marrow suppression or jaundice. A sentence for care in use in extremes of temperature has been included.
In section 4.5 (Interactions with other Medicaments and other forms of Interaction) levodopa and lithium have been added. Other interactions added include oral anticoagulants, trifluoperazine and antacids.
In section 4.6 (Pregnancy and Lactation) a sentence advising breast feeding at the discretion of the physician has been included.
In section 4.8 (Undesirable Effects) the sentence covering hyperprolactinaemia at higher dosages, has been extended to include an effects on certain hormone dependent breast neoplasms. Serious arrhythmias have been reported. The passage regarding tardive dyskinesia now includes advice that trifluoperazine be discontinued in the event if tardive dyskinesia. A cross-reference to section 4.4 regarding withdrawal reactions now appears.
In section 5.2 (Pharmacokinetic Properties) elimination via the bile and urine has been added.
In section 10 (Date of (Partial) Revision of the Text) the date has been updated to 20-Jul-2010.
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Updated on 24/03/2010 and displayed until 05/10/2010
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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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 21-Jan-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): Added warnings on risk of venous thromboembolism (VTE) for all antipsychotics and warnings on increased mortality in elderly people with dementia for all conventional (typical) antipsychotics.
In section 4.8 (Undesirable Effects): Added text stating how cases of venous thromboembolism including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs.
In section 10 (Date of (Partial) Revision of the Text: Updated from 12/7/2008 to 21/01/2010.
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Updated on 26/08/2008 and displayed until 24/03/2010
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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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Change to section 1 -Name of the Medicinal product
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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 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 12-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1: Name has been re-arranged as per current legislation.
Section 4.4: Added requested warnings re: QT prolongation and the risk of cerebrovascular accident at license renewal
Section 4.5: Added requested interactions resulting in QT prlongation at license renewal
Section 4.8: Added requested undesirable effects relating to QT prolongation at license renewal
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Updated on 20/08/2004 and displayed until 26/08/2008
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Updated on 28/08/2002 and displayed until 20/08/2004
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 31/07/2002 and displayed until 28/08/2002
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Reasons for adding or updating:
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Change to section 1 - trade name
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Updated on 21/11/2001 and displayed until 31/07/2002
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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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