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Ricesteele Manufacturing Ltd

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: 24/01/2012
SPC Paralink Six Plus Paracetamol 250mg/5ml oral solution

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 24/01/2012 and displayed until Current
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
Date of revision of text on the SPC:   02-Dec-2011
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company



Section 6.5 has been revised to include 'A 5ml dosing syringe with markings at both 2.5ml and 5ml is provided with the bottle'

Section 10 has been revised to December 2011.

Updated on 22/12/2011 and displayed until 24/01/2012
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • 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 10 - Date of revision of the text
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   10-Nov-2011
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company

Section 4.2 the posology has been updated to a table format and dosages standardised for all liquid paracetamol products for children, as requested by the IMB.
Section 4.3 Spelling correction to 'Hypersensitivity'
Section 4.4 Additional points added as per IMB request.
Spelling correcion to 'colestyramine'
Section 10 updated to October 2011
Updated on 19/07/2011 and displayed until 22/12/2011
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   31-Mar-2011
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company

In section 3 the description of the product has changed to colourless / straw coloured.

In section 5.1 the ATC classification of paracetamol has been added.

Section 10 has been updated to March 2011.
Updated on 03/09/2009 and displayed until 19/07/2011
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Paracetamol

Versions

 
24/01/2012 to Current
22/12/2011 to 24/01/2012
19/07/2011 to 22/12/2011
03/09/2009 to 19/07/2011
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Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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