Summary of Product Characteristics
last updated on the eMC:
22/03/2010
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 22/03/2010 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 01-Mar-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
In section 7 Marketing Authorisation Holder the address has been amended to:
Forest Laboratories UK Limited
Riverbridge House
Anchor Boulevard
Crossways Business Park
Dartford
Kent
DA2 6SL
UK
In section 10 the Date of the Revision of the Text has been updated to:
March 2010
|
|
Updated on 22/05/2009 and displayed until 22/03/2010
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special warnings and precautions for Use
|
| Date of revision of text on the SPC: 12-May-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| 4.4 Special Warnings and Precautions for Use
Rarely, prolonged use in susceptible individuals with poor dental hygiene and associated plaque may lead to an increased risk of dental caries. Patients should, therefore be instructed to alternate the site of application and careful attention should be paid to dental hygiene, particularly in those areas where the tablet is applied. In conditions where xerostomia (dry mouth) may occur, e.g. during concomitant medication with drugs having anticholinergic effects, patients should be instructed to moisten the buccal mucosa with the tongue, or with a little water, prior to insertion of Suscard.
Prescribe with caution to patients with; hypothyroidism, malnutrition, hepatic impairment, renal impairment, hypothermia, hypoxaemia or other ventilation and perfusion abnormalities.
The bold and underlined text represents the chnage and the newly added text.
|
|
Updated on 27/09/2006 and displayed until 22/05/2009
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 09/2006 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 4.8 has been updated to include the statement 'Blisters of the tongue and oral mucosa have been associated with glyceryl trinitrate treatment'.
Section 10 has been updated to show the date of this revision as September 2006.
|
|
Updated on 20/01/2003 and displayed until 27/09/2006
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
|
|
Updated on 18/09/2001 and displayed until 20/01/2003
|
Reasons for adding or updating:
|
-
Addition of Legal Category
|
|
Updated on 14/08/2001 and displayed until 18/09/2001
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 14/08/2001 and displayed until 14/08/2001
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 10/08/2001 and displayed until 14/08/2001
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 06/09/1999 and displayed until 10/08/2001
|
Reasons for adding or updating:
|
|
|
|
