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MSD Ireland (Human Health) Limited

Red Oak North, South County Business Park, Leopardstown, Dublin 18, Ireland
Telephone: +353 1 299 8700
Fax: +353 1 299 8701
Medical Information e-mail: medinfo_ireland@merck.com
Summary of Product Characteristics last updated on medicines.ie: 14/11/2017
SPC SINEMET CR 50mg/200mg Prolonged-release 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 14/11/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   27-Oct-2017
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 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

Updated on 15/01/2016 and displayed until 14/11/2017
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   12-Jan-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Reasons for submission: Change to Section 3 - Pharmaceutical form
Which SPC sections have changed: Sections 3, 10

Detailed SPC change information: Amendment to tablet description in section 3 (scoreline and “521” are now on opposite sides)


Updated on 21/08/2014 and displayed until 15/01/2016
Reasons for adding or updating:
  • 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 10 - Date of revision of the text
Date of revision of text on the SPC:   11-Aug-2014
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 17/06/2013 and displayed until 21/08/2014
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   06-Jun-2013
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 19/02/2013 and displayed until 17/06/2013
Reasons for adding or 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
Date of revision of text on the SPC:   13-Feb-2013
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, 10.
Updated on 16/10/2009 and displayed until 19/02/2013
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   30-Sep-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Post BSR

 

(correction)
Typo correction Section 4.9

 

Updated on 09/10/2009 and displayed until 16/10/2009
Reasons for adding or 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
Date of revision of text on the SPC:   30-Sep-2009
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 24/08/2009 and displayed until 09/10/2009
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:   31-Jul-2009
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 24/07/2008 and displayed until 24/08/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   11/2007
Legal Category:   prescription only

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 28/08/2007 and displayed until 24/07/2008
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Levodopa
   Carbidopa