HALF SINEMET CR 25mg/100mg Prolonged-Release Tablets

Product Information *

  • Company:

    Organon Pharma (Ireland) Limited
  • Status:

    Updated
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

When a pharmaceutical company changes any document, 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 25 June 2019

File name

IE-Sinemet Half CR-EN-SPC-20171027-CRT_1561456559.pdf

Reasons for updating

  • Improved presentation of SPC

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Converted the SPC from word format to pdf file format 

 

Updated on 21 February 2019

File name

Sinemet CR-Half Sinemet CR_PIL_QRD_BRX_PRO_CRT_1550762291.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 15 November 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 15 November 2017

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to sections 4.4 & 4.8 C in line with the PRAC recommendation on carbidopa / levodopa regarding Dopamine dysregulation syndrome

Update to section 5.1 to insert the ATC code & pharmacotherapeutic group

Editorial amendments to section 4.2 of the SPC



Updated on 14 November 2017

File name

PIL_13244_625.pdf

Reasons for updating

  • New PIL for new product

Updated on 14 November 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 14 January 2016

Reasons for updating

  • Change to date of revision
  • Change to appearance of the medicine

Updated on 29 July 2015

Reasons for updating

  • Change of manufacturer
  • Change to further information section

Updated on 13 February 2015

Reasons for updating

  • Change to date of revision

Updated on 21 August 2014

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Sections 4.5, 4.8, 10 - Added warning regarding use with dopamine-depleting agents

Updated on 20 August 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Addition of information on reporting a side effect.

Updated on 17 June 2013

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

MA Holder address change - Sections 7, 10

Updated on 18 April 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 19 February 2013

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Updates to Sections 4.4, 4.8, 10

Updated on 13 July 2010

Reasons for updating

  • Change to date of revision

Updated on 09 October 2009

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



- Section 1: Product name
- Section 6.4: Storage conditions
- Section 10: Date of revision

 

 

Updated on 08 October 2009

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to further information section
  • Change to date of revision

Updated on 24 August 2009

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 8 - MA number
  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

PA transfer (and change of distributor from BMS to MSD)
- Section 7: Change of MAH holder
- Section 8: Change of PA number
- Section 10: July 2009

 

 

 

 

Updated on 13 August 2009

Reasons for updating

  • Change to further information section

Updated on 30 October 2008

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The changes are as a result of a variation to implement a commission decision on an article 30 referral.
Changes have been made to the following sections: 1, 2, 3, 6.1, 6.5, 9 & 10.

Updated on 24 July 2008

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The change relates to update section 4.4 to include warning in relation to melanoma.

Updated on 09 June 2008

Reasons for updating

  • New PIL for medicines.ie

Updated on 28 August 2007

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)