Summary of Product Characteristics
last updated on the eMC:
10/01/2012
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 10/01/2012 and displayed until Current
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Reasons for adding or updating:
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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: 14-Dec-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.5 updated to correct the specification of the blister foil from '250 micron PVC/40gsm PVDC blister tray' to '250 micron PVC/60gsm PVDC blister tray'
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Updated on 18/10/2011 and displayed until 10/01/2012
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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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| Date of revision of text on the SPC: 11-Nov-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 - addition of further warnings:-
Do not exceed stated dose
Do not use for longer than 3 days without medical advice
Allow 4 hours between the last dose of Day Nurse and the dose of Night Nurse
Not to be taken with any other cough, cold or antihistamine containing products
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Updated on 26/08/2009 and displayed until 18/10/2011
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 14-Aug-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 6.1, Erythrosine (E127) has been removed from the capsule shell.
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Updated on 04/03/2008 and displayed until 26/08/2009
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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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| Date of revision of text on the SPC: 02/2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.8 Changed to include hypersensitivity reactions and anaphylaxis.
Section 10 Updated to 14/02/08
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Updated on 23/04/2007 and displayed until 04/03/2008
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 20/04/2007 and displayed until 23/04/2007
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Reasons for adding or updating:
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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 4.9 - Overdose
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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: 02/2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.5 Update BAN cholestyramine to rINN colestyramine
Section 4.9 Update to include generic overdose statements for paracetamol, pseudoephedrine hydrochloride, promethazine and dextromethorphan/pholcodine
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Updated on 17/05/2005 and displayed until 20/04/2007
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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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