Requip 1 mg film-coated 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 13 June 2023
File name
ie-spc-requip1mg-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-spc-requip1mg-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-requip1mg-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-requip1mg-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 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
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 - 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
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 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 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 - 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 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 4.5 - 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
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
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