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

Ricesteele Manufacturing Ltd
Unit 31, Cookstown Industrial Estate, Tallaght, Dublin 24,
Telephone: +353 1 451 0144
Fax: +353 1 452 1875
Summary of Product Characteristics last updated on medicines.ie: 23/08/2011
SPC Paralink 500mg Suppositories

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 23/08/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
Date of revision of text on the SPC:   31-Aug-2010
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 1 name should read Paralink 500mg Suppositories

Section 4.5 'choleystyramine' should be 'colestyramine'

Section 5.2 'product' should read 'produce'
Updated on 30/07/2010 and displayed until 23/08/2011
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   24-May-2010
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 4.1 Typographical correction.  The word 'pain' was added to  the end of the indications section.

Section 4.4 Additional information added.

Section 4.5 This section was updated from 'None known' to include interactions of paracetamol with other medicaments and other forms of interaction.

Section 4.8 Additional information added.

Section 4.9 Updated to MHRA paracetamol overdose wording.

Section 5.2 Revised information added.

Section 10 Revised.
Updated on 22/12/2009 and displayed until 30/07/2010
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   08-Dec-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 6.1
The name of one of the excipients macrogol ester has been revised from the USP name to the Ph. Eur. name macrogol stearate.

Section 10
Revised to December 2009.
Updated on 11/11/2009 and displayed until 22/12/2009
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
  • 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:   16-Oct-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
In section 5.1 the ATC code has been added.
Sections 9 and 10 have been updated following renewal of this product.
Updated on 17/08/2007 and displayed until 11/11/2009
Reasons for adding or updating:
  • Changes to therapeutic indications
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07/2004
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
BAN to rINN Polyoxyl 40 stearate to macrogol ester
 
Section 10 July 2004
Updated on 09/08/2004 and displayed until 17/08/2007
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 20/08/2003 and displayed until 09/08/2004
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Updated on 30/06/2003 and displayed until 20/08/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

Document Links

 
  View all medicines
from this company
View Document
Bookmark and Share

Active Ingredients

 
  Paracetamol