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Requip 0.25 mg film-coated tablets

*
Pharmacy Only: Prescription

  • Company:

    GlaxoSmithKline (Ireland) Ltd

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Ropinirole Hydrochloride

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

Updated on 13 June 2023

File name

ie-spc-requip0.25mg-issue12draft1.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 07 June 2023

File name

ie-pl-requipcombined-issue11draft1.pdf

Reasons for updating

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

Updated on 25 January 2022

File name

ie-pl-requipcombined-issue10draft1.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 25 January 2022

File name

ie-spc-requip0.25mg-issue11draft1.pdf

Reasons for updating

  • 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)

Updated on 25 January 2022

File name

ie-pl-requipcombined-issue10draft1.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 11 May 2021

File name

ie-spc-requip0.25mg-issue10draft3.pdf

Reasons for updating

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

Updates to the SPC:

Section 4.4 and 4.8: addition of mania

Section 4.4: PRAC update - DAWS

Section 4.4: excipients update - sodium content

Section 4.8: update to reporting of side effects

Including editorial updates across the SPC

Updated on 11 May 2021

File name

ie-pl-requipcombined-issue9draft2.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 11 April 2019

File name

ie-pl-requipcombined-issue8draft1.pdf

Reasons for updating

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

Updated on 11 April 2019

File name

ie-spc-requip0.25mg-issue9draft2.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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

Update to SPC: update sections 4.6 and 5.2 with new pregnancy data

 Update Section 4.7 to include a reference to “hallucinations” following the PRAC recommended wording.

Updated on 15 November 2017

Reasons for updating

  • New SPC for new product

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

Updated on 15 November 2017

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • 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 4.6: Breast-feeding section updated and new sub section fertility included.

Section 5.3: Reproductive toxicity section updated MRHD frequency with dosage. Carcinogenicity section updated to include no evidence in the mouse.

Updated on 04 October 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 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: Section 4.4 updated with the Dopamine and Hallucinations warnings

 

Section 4.8 updated with Dopamine in the general disorder with not know frequency

Updated on 03 October 2017

File name

PIL_9104_247.pdf

Reasons for updating

  • New PIL for new product

Updated on 03 October 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 6 - date of revision

Updated on 22 May 2017

Reasons for updating

  • 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)

Free text change information supplied by the pharmaceutical company

 Section 6.5 has been updated to reflect the change from
PVC/PCTFE/PVC blister base film material to PVC/PE/PVdC/Aluminium/paper

Updated on 26 September 2016

Reasons for updating

  • 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)

Free text change information supplied by the pharmaceutical company

Section 6.5 – Deletion of reference to PVC/PCTFE and HDPE bottle container. Introduction of Child resistant senior friendly  Aluminium lidding foil to PVC/PCTFE/PVC blisters and Introduction of child resistant senior friendly Aluminium lidding foil to foil/foil blisters.

Updated on 26 September 2016

Reasons for updating

  • Change to date of revision
  • Deletion of a pack size

Updated on 18 August 2016

Reasons for updating

  • Change to date of revision
  • Deletion of a pack size
  • Correction of spelling/typing errors

Updated on 08 April 2016

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - 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

4.2       Posology and method of administration – minor formatting

            4.4        Special warnings and precautions for use – addition of Neuroleptic malignant syndrome information

            4.8 Adverse events – addition of Dopamine dysregulation syndrome

Updated on 07 April 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of manufacturer
  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability
  • Correction of spelling/typing errors

Updated on 15 July 2015

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

Section 7 - change to Ireland MAH address

Updated on 15 July 2015

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 18 November 2014

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

Section 4.8 Undesirable effects - under GENERAL DISORDERS - COMMON SIDE EFFECTS,  added "Oedema peripheral (including leg oedema)".
Section 4.8 Undesirable effects - Reporting Side Effect - updated the reporting of side effects from IMB to HPRA.

Updated on 17 November 2014

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 28 January 2014

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

Changes to:

 

 

Section 2 - QUALITATIVE AND QUANTITATIVE COMPOSITION,
Section 4.3 - Contraindications,
Section 4.4 - Special warnings and precautions for use,
Section 4.5 - Interaction with other medicinal products and other forms of interaction,
Section 4.6 - Pregnancy and lactation,
Section 4.8 - Undesirable effects,
Section 5.2 - Pharmacokinetic properties,
Section 6.6 - Special precautions for disposal

 

Updated on 24 January 2014

Reasons for updating

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

Updated on 21 August 2012

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 13 April 2010

Reasons for updating

  • Change of manufacturer

Updated on 25 March 2009

Reasons for updating

  • Change to side-effects

Updated on 07 October 2008

Reasons for updating

  • Change to side-effects

Updated on 09 May 2008

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about missed dose

Updated on 09 November 2005

Reasons for updating

  • Improved electronic presentation

Updated on 13 October 2004

Reasons for updating

  • New PIL for medicines.ie