Sinemet 12.5mg/50mg Tablets

  • Name:

    Sinemet 12.5mg/50mg Tablets

  • Company:
    info
  • Active Ingredients:

    Carbidopa, Levodopa

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/02/19

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Summary of Product Characteristics last updated on medicines.ie: 21/5/2019

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MSD Ireland (Human Health) Limited

MSD Ireland (Human Health) Limited

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1 - 0 of 84 items.Total: Infinity pages

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 21 May 2019 SmPC

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 SmPCs

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 PIL

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 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 14 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 November 2017 SmPC

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 PIL

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 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 2 July 2015 SmPC

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 PIL

Reasons for updating

  • Change to date of revision

Updated on 26 January 2015 SmPC

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 SmPC

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 PIL

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 PIL

Reasons for updating

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

Updated on 19 February 2013 SmPC

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 2 October 2012 PIL

Reasons for updating

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

Updated on 9 October 2009 SmPC

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 SmPC

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 SmPC

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 SmPC

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 2 August 2005 SmPC

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 SmPC

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 SmPC

Reasons for updating

  • New SPC for medicines.ie

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