Sinemet 12.5mg/50mg Tablets *
Pharmacy Only: Prescription

Updated on 09 May 2022

File name

62790266b1839.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 04 May 2022

File name

ie-Sinemet12.5-50-SPC- April MAT CRT_1651659756.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 04 May 2022

File name

ie-QRD-ie-pl-sinemet-12.5-50 April CRT_1651659538.pdf

Reasons for updating

  • Change to marketing authorisation holder

Updated on 09 November 2021

File name

QRD-ie-pl-sinemet-12.5-50-CRT August2021_1636471015.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to packaging

Free text change information supplied by the pharmaceutical company

Updated Pack type

Updated on 09 November 2021

File name

IE-sinemet-12.5-50-EN-SPC-AUG2021 CRT_1636469587.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

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

Updated on 16 February 2021

File name

IE-Sinemet-12.5mg-50mg-EN-SPC-20210126-CRT (002)_1613469963.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

Updated information regarding the score line for Sinemet 10mg/100mg Tablets in section 4.2

 

Updated on 16 February 2021

File name

IE-Sinemet-12.5mg-50mg-EN-PIL-20210126-CRT (002)_1613469798.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 10 September 2020

File name

IE-Sinemet-12.5mg-50mg-EN-SPC-20200903-CRT (002).pdf_1599750123.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • 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

  • Updated information regarding the score line for Sinemet 12.5mg/50mg Tablets in Sections 3 and 4.2 to the following: “The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. If subdivided, the tablet should be consumed as a whole dose.
  • Updated information regarding the score line for Sinemet Plus 25mg/100mg Tablets in section 4.2
  • Addition of the following information in section 4.2: “Advise the patient not to apply too much force when removing the tablet from the packaging. If the tablet breaks when it is removed from the packaging, it should be consumed only if the whole dose can be taken. If it cannot, the pieces of the broken tablet should be discarded, and another tablet taken from the packaging.

Administration of a partial dose may result in worsening of symptoms.

  • Update to HPRA details in section 4.8 /  Reporting of suspected adverse reactions.

Updated on 10 September 2020

File name

IE-Sinemet-12.5mg-50mg-EN-PIL-20200903-CRT (002).pdf_1599748253.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 21 May 2019

File name

IE-Sinemet-12.5mg-50mg-EN-SPC-20181108-CRT_1558432192.pdf

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 4.2 - Posology and method of administration
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Change from joint to individual SPCs

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

Free text change information supplied by the pharmaceutical company

  • Change from a joint SmPC for Sinemet 12.5mg/50mg Tablets, Sinemet 10mg/100mg Tablets, Sinemet Plus 25mg/100mg Tablets & Sinemet 25mg/250mg Tablets into 2 separate SmPCs: one individual SmPC for Sinemet 12.5mg/50mg Tablets and one joint SmPC for Sinemet 10mg/100mg Tablets, Sinemet Plus 25mg/100mg Tablets & Sinemet 25mg/250mg Tablets.
  • Addition of information in section 4.2 regarding Sinemet 10mg/100mg, Sinemet Plus 25mg/100mg & Sinemet 25mg/250mg Tablets

Updated on 21 February 2019

File name

Sinemet 12.5 - PIL_QRD_BRX_PRO_CRT_1550762573.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 14 November 2017

Reasons for updating

  • New SPC for new product

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

Updated on 14 November 2017

File name

PIL_15506_9.pdf

Reasons for updating

  • New PIL for new product

Updated on 14 November 2017

Reasons for updating

  • 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 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 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 29 July 2015

Reasons for updating

  • Change to name of manufacturer

Updated on 02 July 2015

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic 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

 SPC Change Details 3, 4.2, 4.4, 4.5, 4.8, 5.2, 10:
Grouping of undesirable effects according to MedDRA system organ class

Updated on 13 February 2015

Reasons for updating

  • Change to date of revision

Updated on 26 January 2015

Reasons for updating

  • 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

Change to Section 10 Only - Date of revision of the text

Updated on 21 August 2014

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
  • Change to section 3 - Pharmaceutical form

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

Free text change information supplied by the pharmaceutical company

Detailed SPC change information: Change in tablet shape and markings, storage conditions, shelf life, pack size; added details for how to report a side effect; added warning regarding use with dopamine-depleting agents.

Updated on 20 August 2014

Reasons for updating

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

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 02 October 2012

Reasons for updating

  • New individual PIL (was previously included in a combined PIL)

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 24 August 2009

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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

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 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 28 August 2007

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

 
Section 4.4:
   
                Addition of:

Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson’s disease.
 
Section 4.8:

Addition of:
 
            Patients treated with dopamine agonists for treatment of Parkinson’s disease, especially at high doses, have been reported as exhibiting signs of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation.

Updated on 02 August 2005

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 7 - Marketing authorisation holder
  • 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)

Updated on 19 January 2005

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 10 - Date of revision of the text

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

Updated on 26 June 2003

Reasons for updating

  • New SPC for medicines.ie

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