Summary of Product Characteristics
last updated on the eMC:
17/11/2011
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 17/11/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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| Date of revision of text on the SPC: 11-Nov-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Addition of 'Do not store above 25 dec C' to section 6.4
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Updated on 17/10/2011 and displayed until 17/11/2011
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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 warnings:
Maximum duration of continued use without medical advice: 3 days
Do not exceed the stated dose
Allow 4 hours between taking other paracetamol containing products and Night Nurse
Not to be taken with other cough, cold and antihistamine containing products
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Updated on 26/08/2009 and displayed until 17/10/2011
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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, Eyrthrosine ( E127) has been removed from the capsule shell.
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Updated on 23/06/2009 and displayed until 26/08/2009
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Reasons for adding or updating:
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Extra statutory information
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| Date of revision of text on the SPC: 04-Mar-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The licence now has unlimited expiry.
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Updated on 21/08/2007 and displayed until 23/06/2009
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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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