Requip-Modutab 2 mg prolonged-release tablets
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 05 December 2023
File name
ie-spc-requipmod2mg-issue14draft1 NO HEADER.pdf
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)
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-requipmod2mg-issue13draft1.pdf
Reasons for updating
- New SPC for new product
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-requipmod2mg-issue12draft2.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-requipmod2mg-issue12draft1.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-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-spc-requipmod2mg-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-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 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-requipmod2mg-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 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 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
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 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
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
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 - administratove 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 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 21 August 2012
Reasons for updating
- Change to section 6.5 - Nature and contents of container
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 and contents of container
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
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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.
Push Through Aluminium Lidding SpecificationIdentity 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
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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