Login

Requip-Modutab 4 mg prolonged-release 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 05 December 2023

File name

ie-pl-requipmodcombined-issue13draft1 NO HEADER.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 13 June 2023

File name

ie-spc-requipmod4mg-issue14draft1.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-requipmodcombined-issue12draft1 .pdf

Reasons for updating

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

Updated on 10 March 2022

File name

ie-spc-requipmod4mg-issue13draft2.pdf

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)

Updated on 25 January 2022

File name

ie-spc-requipmod4mg-issue13draft1.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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-requipmodcombined-issue11draft1.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 11 May 2021

File name

ie-pl-requipmodcombined-issue10draft2.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 May 2021

File name

ie-spc-requipmod4mg-issue11draft3.pdf

Reasons for updating

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

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-spc-requipmod4mg-issue11draft3.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 17 December 2020

File name

ie-pl-requipmodcombined-issue9draft1.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 11 April 2019

File name

ie-pl-requipmodcombined-issue7draft2.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-requipmod4mg-issue10draft2.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 section 4.6 and 5.2 with the new pregnancy data.

Update to 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 03 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

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 02 October 2017

File name

PIL_13027_385.pdf

Reasons for updating

  • New PIL for new product

Updated on 02 October 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - driving and using machines
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 09 May 2017

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

Update to the SPC section 1, 4.2, 4.4, 5.1 and 5.2  - update to align 'Requip-modutab'
Update to section 6.5 - film material updated

Updated on 19 August 2016

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change to improve clarity and readability

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 reference to section 4.8

Section 4. 8– Addition of sudden onset of sleep to common side effects under nervous system disorders and deletion of sudden onset of sleep from uncommon side effects.

Updated on 18 August 2016

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Correction of spelling/typing errors
  • Improved electronic presentation

Updated on 06 July 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- nature of container

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 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 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 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 21 May 2015

Reasons for updating

  • 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 – update to the name change of Irish regulatory agency from IMB to HPRA

Updated on 20 May 2015

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 02 June 2014

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 4.4 - Requip Modutab tablets are designed to release medication over a 24hr period. If rapid gastrointestinal transit occurs, there may be risk of incomplete release of medication, and of medication residue being passed in the stool.

Section 4.8 - Update Undesirable Effects to include aggression and formatting of the AE table

All other sections - administrative and formatting changes

Updated on 30 May 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to date of revision
  • Change to dosage and administration
  • Correction of spelling/typing errors

Updated on 20 December 2013

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 4.5 - Addition of the following paragraph “In patients receiving the combination of vitamin K antagonists and ropinirole, cases of unbalanced INR have been reported. Increased clinical and biological surveillance (INR) is warranted”.
Section 10 - Updated with new date of revision of text

Updated on 19 December 2013

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 16 August 2012

Reasons for updating

  • Introduction of new pack/pack size

Updated on 20 June 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

Module 3.2.P.7  Container Closure System

Ropinirole PR Tablets are packed into blister strips.  All quoted units are nominal.

The blister strip comprises a 127 mm opaque polyvinylchloride (PVC) film, laminated to a 51 mm polychlorotrifluoroethylene (PCTFE) film, laminated to another 127 mm film of polyvinylchloride (PVC), and sealed with a 20 mm push through aluminium lidding foil with a vinyl acrylic heat seal coating.  The outer PVC film is pigmented white with titanium dioxide, and the aluminium foil can be unprinted or pre-printed. The product contact materials are PVC and heat seal laquer.

PVC/PCTFE Film specification

Identity test by IR – PVC (product side)

                Concordant with reference

Identity test by IR – PCTFE (barrier layer)

                Concordant with reference

Visual inspection

                Absence of critical defects

Dimensional inspection by callipers and gauges

                Complies with critical  limits

Push Through Aluminium Lidding Specification

Identity Test by IR - Heat seal lacquer of the lidding foil.

                Concordant with reference

Visual inspection

                Absence of critical defects

Dimensional inspection by callipers and gauges

                Complies with critical  limits

PVC/PCTFE/PVC Film specification

Identity test by IR - PVC

                Concordant with reference

Visual inspection

                Absence of critical defects

Dimensional inspection by callipers and gauges

                Complies with critical  limits

 

SPC Section 6.5:  Nature and Contents of Container

PVC/PCTFE/PVC/Aluminium

Updated on 21 February 2011

Reasons for updating

  • Change to side-effects
  • Change to, or new use for medicine

Updated on 09 December 2009

Reasons for updating

  • Change of manufacturer

Updated on 12 September 2008

Reasons for updating

  • Addition of manufacturer

Updated on 28 March 2008

Reasons for updating

  • New PIL for new product