Summary of Product Characteristics
last updated on the eMC:
17/10/2011
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 17/10/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and method of administration
|
| 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
|
| 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
|
|
Updated on 25/06/2009 and displayed until 17/10/2011
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special warnings and precautions for Use
|
| Date of revision of text on the SPC: 03-Mar-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| In section 4.4, the alcohol levels have been amended.
|
|
Updated on 07/01/2008 and displayed until 25/06/2009
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 6.1 - List of Excipients
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 12/2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 4.4 Addition of special leaflet warnings regarding alcohol, glucose and sodium.
Section 6.1 Removal of sodium benzoate from excipients. Addtion of ascorbic acid and disodium edentate. Sodium citrate replaces sodium acid citrate.
Section 10 Date amended to December 2007
|
|
Updated on 25/10/2007 and displayed until 07/01/2008
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 08/2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 4.4 Addition of "Patients with rare glucose-galactose malabsorption should not take this medicine."
Section 10 Updated
|
|
Updated on 23/08/2007 and displayed until 25/10/2007
|
Reasons for adding or updating:
|
-
Change to section 6. 5 - Nature and Contents of Container
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 08/2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Change to Section 6.5 - Addition of PET bottles as an additional type of immediate packaging.
Change to Section 10 - to update date of revision of text
|
|
Updated on 21/08/2007 and displayed until 23/08/2007
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
|