Summary of Product Characteristics
last updated on the eMC:
05/12/2008
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 05/12/2008 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special warnings and precautions for Use
|
| Date of revision of text on the SPC: 01-Dec-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.4 -
Warning Regarding Suicidal ideation and behaviour in patients treated with antiepileptic medication added.
|
|
Updated on 29/07/2008 and displayed until 05/12/2008
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.9 - Overdose
-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
-
Change to section 4.8 - Undesirable Effects
-
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
-
Change to section 3 - Pharmaceutical form
-
Change to section 4.2 - Posology and method of administration
|
| Date of revision of text on the SPC: 01-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Section 3:
Due to Harmonisation of the Module 3 for both Tablets and Capsules the product descriptions have been clarified for Neurontin Capsules. The description for Neurontin Film-Coated Tablets have changed from a printed tablet to a scored tablet.
Section 4.2:
A statement has been added regarding the discontinuation of Gabapentin for all indications.
Section 4.4:
Lactose warning for Neurontin Hard Capsules has been modified.
Section 4.8:
The adverse drug reaction section has been re-formatted to a table format.
Breast hypertrophy, gynaecomastia and myoclonus have been added as adverse drug reactions.
A warning for patients on haemodialysis has also been added.
Section 4.9:
Warning added regarding combinations with other CNS depressants.
Section 6.1:
Excipients have changed due to the Tablets formulation change from printed tablets to scored tablets.
Section 6.5:
Nature and contents of container – section was harmonised due to the MRP renewal.
Section 9:
New renewal dates added
Section 10:
New revision date added
|
|
Updated on 01/10/2007 and displayed until 29/07/2008
|
Reasons for adding or updating:
|
-
Change to section 6.1 - List of Excipients
|
| Date of revision of text on the SPC: 09/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| 6.1 Change in the composition of the printing ink for the 600 mg Tablets
|
|
Updated on 08/12/2006 and displayed until 01/10/2007
|
Reasons for adding or updating:
|
-
Change due to harmonisation of SPC
|
| Date of revision of text on the SPC: 08/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Sections 1 - 5.3 & sections- 6.2, 6.5, 6.6, 8-10 changes due to harmonisation - in line with the EU Article 30 Referral.
|
|
Updated on 29/11/2006 and displayed until 08/12/2006
|
Reasons for adding or updating:
|
-
Improved Electronic Presentation
|
|
Updated on 08/09/2006 and displayed until 29/11/2006
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 22/11/2005 and displayed until 08/09/2006
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
|