Sinemet 12.5mg/50mg Tablets
*Company:
Organon Pharma (Ireland) LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)*Additional information is available within the SPC or upon request to the company
Updated on 16 January 2024
File name
ie-QRD-ie-pl-sinemet-12.5-50 october UTI CRT.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 16 January 2024
File name
IE-Sinemet 12.5-50-EN_SPC-UTI-2023-10-13- CRT.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 August 2023
File name
ie-QRD-ie-pl-sinemet-12.5-50 2023 AugCRT.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 24 August 2023
File name
ie-QRD PL Sinemet combined August 2023 CRT.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 23 August 2023
File name
Sinemet 12.5-50-SPC-IE-EN- August 2023 CRT.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 31 January 2023
File name
IE-Sinemet 12.5-50-EN-SPC- 20220422-CRT.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 09 May 2022
File name
ie-Sinemet12.5-50-SPC- April MAT CRT.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.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.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.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.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).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).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.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.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.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.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
File name
PIL_15506_9.pdf
Reasons for updating
- New PIL for new product
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
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
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
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
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
Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson’s disease.
Addition of:
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)