Neupro 4 mg/24hr, 6 mg/24hr, 8 mg/24hr Transdermal Patch

*
Pharmacy Only: Prescription
  • Company:

    UCB (Pharma) Ireland Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 15 December 2023

File name

ie-pil-neupro-tdp-4,6,8mg24hr.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 14 December 2023

File name

ie-spc-neupro-tdp-4,6,8mg24hr.pdf

Reasons for updating

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

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 14 December 2023

File name

ie-pil-neupro-tdp-4,6,8mg24hr.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 27 January 2021

File name

ie-pil-neupro-tdp-4,6,8mg24hr-en.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Update to section warnings & precautions related to impulse control and other disorders (dopamine dysregulation disorder and dopamine agonist withdrawal syndrome).

Addition of ‘’or nurse’’ in various sections.

Updated on 27 January 2021

File name

ie-spc-neupro-tdp-4,6,8mg24hr-en.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to section 4.4 related to impulse control and other disorders (dopamine dysregulation disorder and dopamine agonist withdrawal syndrome).

Removal of information for skin adhesion in section 5.1.

Updated on 22 January 2020

File name

3.1 IE PIL - Neupro 4mg, 6mg, 8mg_24h transdermal patch - CLEAN - 21JAN2020.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

To include “Rhabdomyolysis” as undesirable effect with frequency “not known” and widen the scope of an existing undesirable effect “increased CPK” based on new pharmacovigilance data.

Updated on 22 January 2020

File name

3. IE SPC - Neupro 4mg, 6mg, 8mg_24h transdermal patch - CLEAN - 21JAN2020.pdf

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

To include “Rhabdomyolysis” as undesirable effect with frequency “not known” and widen the scope of an existing undesirable effect “increased CPK” based on new pharmacovigilance data.

Updated on 02 August 2018

File name

4 6 8 mg 24 h PIL IE.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 02 August 2018

File name

4 6 8 mg 24h SPC IE.pdf

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change concerning a linguistic Review - Dropped Head Syndrome and additional changes 

Section 4.8 Undesirable effect- Tabulated list of adverse reactions; Section 10- Date of revision of the text

Updated on 17 January 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 17 January 2018

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

Changes were made to the following sections:

Section 4.2: Changes to duration of pressing during the application of the patch.

 Section 6.5: amendment to reflect the change of design from cardboard to plastic and to change an existing pack-size.

Updated on 01 December 2017

File name

PIL_14783_537.pdf

Reasons for updating

  • New PIL for new product

Updated on 01 December 2017

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Individual PILs superseded by joint PIL

Updated on 16 October 2017

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In the section 7.0 (Marketing Authorisation Holder) address is updated

Updated on 16 October 2017

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 26 June 2017

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

To include the 14 pack size in the section 6. 5.

Updated on 23 June 2017

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents

Updated on 13 December 2016

Reasons for updating

  • Change to other sources of information section

Updated on 15 November 2016

Reasons for updating

  • Change to other sources of information section

Updated on 15 March 2016

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

5.1 Pharmacodynamic properties

 

Reference to a skin adhesion study has been included.

 

6.3 Shelf life

 

The shelf life has increased to 30 months (from 2 years).

 

6.4 Special precautions for storage

 

The storage conditions have been updated to “Do not store above 30°C” (previously 25°C).

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

The date of last renewal has been added: 22 January 2016

 

10. DATE OF REVISION OF THE TEXT

 

The date of revision has been added: 02/2016

Updated on 10 March 2016

Reasons for updating

  • Change to storage instructions
  • Change to date of revision
  • Change to dosage and administration

Updated on 15 February 2016

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Deletion of a pack size

Updated on 12 February 2016

Reasons for updating

  • Addition of separate SPCs covering individual presentations

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 30 June 2015

Reasons for updating

  • Change to side-effects

Updated on 25 September 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to improve clarity and readability

Updated on 17 February 2012

Reasons for updating

  • Change to instructions about overdose

Updated on 13 May 2011

Reasons for updating

  • Change to further information section

Updated on 02 March 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of special precautions for disposal

Updated on 31 August 2010

Reasons for updating

  • New PIL for medicines.ie