go to medicines.ie homepage
Font Size
Search for:  
select
  Advanced Search

Bayer Limited
The Atrium, Blackthorn Road, Dublin 18,
Telephone: +353 1 2999 313
Fax: +353 1 2061 456
Summary of Product Characteristics last updated on medicines.ie: 22/08/2011
SPC Redoxon Double Action Effervescent Tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 22/08/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   13-May-2011
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 7: THe PA holder has been transferred from Bayer plc to Bayer Ltd

Section 8: PA number is now 1410/50/1
Updated on 13/07/2010 and displayed until 22/08/2011
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   07-Jul-2010
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
The compoistion of the excipient betacarotene has been changed from :
beta-carotene 1% (beta carotene, alpha tocopherol, sodium ascorbate, edible fat, acacia, sucrose, maltodextrin)


to:
beta-carotene 1% (beta carotene crystalline, alpha tocopherol, sodium ascorbate crystalline, medium chain triglycerides, acacia, sucrose, maltodextrin and silicon dioxide)
Updated on 01/09/2009 and displayed until 13/07/2010
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   14-Aug-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 1: strength has been added to the name.

Section 2: Has been updated to the following:

1 effervescent tablet contains:

                   Ascorbic acid (vitamin C)                                1000 mg

Zinc (in form of 32 mg zinc citrate trihydrate)       10 mg

 

Excipients:

                   Aspartame       15mg

                   Sorbitol            655mg

                   Sodium            8.4mmol

                  

                   For a full list of excipients, see section 6.1


 Section 4.4: The following text has been added:

 

Patients suffering from renal insufficiency should consult a physician prior to intake of large doses of ascorbic acid.

Section 6.1:
E420 has been added after sorbitol.
E951 has been added after aspartame.

Section 6.5: 'Not all pack sizes may be marketed' has been added.

 

 
Updated on 15/07/2008 and displayed until 01/09/2009
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09/2007
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
 

Section 9 Date of first authorisation / Renewal of Authorisation changed to:

Date of First Authorisation: 2nd November 2001

Date of Last Authorisation: 2nd November 2006

 

Section 10 Date of (partial) revision of the text

September 2007
Updated on 10/08/2006 and displayed until 15/07/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09/2005
Legal Category:   other

Free-text change information supplied by the pharmaceutical company
Section 7 MA Holder changed from Roche Products Ltd to Bayer plc
Section 8 MA Number changed to PA 21/73/1
Section 9 Date of Authorisation changed to September 2005
Section 10 Date of Revision changed to September 2005
Updated on 11/08/2005 and displayed until 10/08/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

Document Links

 
  View all medicines
from this company
View Document
Bookmark and Share