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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 180mg 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 should read Paralink 180mg Suppositories

Section 4.5 'choleystyramine' should read '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:   18-May-2010
Legal Category:   Supply through pharmacy only

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

Section 4.4 Additional information added.

Section 4.5 Revised from 'None known' to include known interactions of paracetamol with other medicaments and other forms of interactions.

Section 4.8 Additional information added.

Section 4.9 Revised to MHRA wording for paracetamol overdose.

Section 5.2 Section updated.

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 changed 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
Change from BAN to rINN polyoxyl 40 stearate to macrogol ester
 
Section 10 July 2004
Updated on 23/07/2004 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 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 29/10/2003 and displayed until 23/07/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 29/10/2003 and displayed until 29/10/2003
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 29/10/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Paracetamol