Summary of Product Characteristics
last updated on the eMC:
08/12/2011
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 08/12/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 1 -Name of the Medicinal product
|
| Date of revision of text on the SPC: 01-Oct-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| eMC document title has been amended from the old name 'Boots Nirolex Dry Cough Relief Lozenges' to the new name 'Boots Dry Cough Relief 2.5 mg Lozenges'
|
|
Updated on 01/08/2011 and displayed until 08/12/2011
|
Reasons for adding or updating:
|
-
Change to section 1 -Name of the Medicinal product
-
Change to section 4.2 - Posology and method of administration
-
Change to section 4.6 - Pregnancy and Lactation
|
| Date of revision of text on the SPC: 01-Oct-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
The changes were to Section 1 to add a new product name - Boots Dry Cough Relief 2.5mg Lozenges
Sections 4.2 & 4.6- to remove reference to "Nirolex"
.
|
|
Updated on 30/07/2010 and displayed until 01/08/2011
|
Reasons for adding or updating:
|
-
Change to section 4.1 - Therapeutic indications
-
Change to section 4.2 - Posology and method of administration
-
Change to section 4.3 - Contraindications
-
Change to section 4.4 - Special warnings and precautions for Use
-
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-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.2 - Re-ordering of some information to aid clarity. 'Children under 6 years: not recommended' deleted as no longer relevant$0'Do not exceed stated dose' and 'Keep out of sight and reach of children' moved to section 4.4$0$0Section 4.3 - Order slightly altered to keep medical conditions and interactions separate$0$0Section 4.4 - 'Should be used with caution i patients with liver disease' and 'Children under 6 years should not be given these lozenges' deleted.$0$0Section 4.5 - Changed as per MHRA annex to interactions with other medicaments and other forms of interaction.$0$0Section 4.8 - Changed as per MHRA annex to Undesirable effects.$0$0Section 4.9 - Changed as per MHRA annex to Overdose. As the MHRA annex is written for children's medicines, the MHRA Annex information regarding the use of naloxone to reverse central or peripheral opioid effects has been placed under a heading 'Information regarding children 6-12 years'$0$0Section 10 - Update to date of revision of the text.$0$0$0$0 |
|
Updated on 26/05/2006 and displayed until 30/07/2010
|
Reasons for adding or updating:
|
-
Change to section 6.1 - List of Excipients
|
| Date of revision of text on the SPC: 31/07/05 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 6.1 Anise oil is now Star anise oil.
|
|
Updated on 28/01/2004 and displayed until 26/05/2006
|
Reasons for adding or updating:
|
-
Change to section 1 - trade name
|
|
Updated on 11/11/2002 and displayed until 28/01/2004
|
Reasons for adding or updating:
|
-
Change to section 4.3 - Contra-indications
-
Change to section 4.4 - Special Warnings and Precautions for Use
-
Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
-
Change to section 4.8 - Undesirable Effects
|
|
Updated on 05/03/2002 and displayed until 11/11/2002
|
Reasons for adding or updating:
|
|
|
|
