Summary of Product Characteristics
last updated on the eMC:
02/09/2010
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 02/09/2010 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.3 - Contraindications
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
-
Change to section 4.8 - Undesirable Effects
-
Change to section 4.9 - Overdose
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 01-May-2010 |
| Legal Category: P, GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.3 – Contra-indications to concomitant use of other sympathomimetic decongestants, phaeochromosytoma and closed angle glaucoma added.
Section 4.4 – Special warnings and precautions added for enlarged prostate gland, occlusive vascular disease and cardiovascular disease. Warning to avoid excessive intake of caffeine added.
Section 4.5 – Addition of table detailing nature of drug interactions.
Section 4.8 – Addition of table listing undesirable effects by ingredient and body system.
Section 4.9 – Revision of treatment advice relating to caffeine, and addition of section relating to phenylephrine.
Section 10 - New revision date
|
|
Updated on 23/04/2009 and displayed until 02/09/2010
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and method of administration
-
Change to section 6. 5 - Nature and Contents of Container
|
| Date of revision of text on the SPC: 23-Mar-2009 |
| Legal Category: P, GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| In section 4.2, the product is no longer recommended for children under the age of 12 years.
|
|
Updated on 19/03/2009 and displayed until 23/04/2009
|
Reasons for adding or updating:
|
-
Change to section 4.1 - Therapeutic indications
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 01-Feb-2008 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
In section 4.1 (Therapeutic Indications) , fatigue and drowsiness have been included
|
|
Updated on 21/08/2007 and displayed until 19/03/2009
|
Reasons for adding or updating:
|
-
Change to section 6.1 - List of Excipients
-
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: 07/2007 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Change to Section 6.1 (excipients) Removal of purified water as it is lost in the manufacturing process, and removal of the word 'solution' from coating ingredients for clarity.
Change to Section 6.5 Addition of 'Compack' wallet and pack sizes of 12 and 14 caplets in this new style packaging.
|
|
Updated on 22/01/2007 and displayed until 21/08/2007
|
Reasons for adding or updating:
|
-
Change to section 4.9 - Overdose
|
| Date of revision of text on the SPC: 11/2006 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.9 (Overdose) has been updated to include the 'generic' overdose statement for Paracetamol containing products as recommended by the MHRA
|
|
Updated on 17/05/2005 and displayed until 22/01/2007
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
|
