Mirapexin prolonged-release tablets *
Pharmacy Only: Prescription

Updated on 10 January 2022

File name

Mirapexin PR - Annex PIL text-EMEA-HC-WS-2169_1641814135.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

  • Updated to show AE reporting details that include “(Northern Ireland)” to the United Kingdom information.
  • Updated to remove “D-” from the zip code of the address of the MAH.
  • Updated revision date to 12.2021.

Updated on 10 January 2022

File name

M5pr-EU-SPC-16 - medicines.ie_1641807814.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 4.8: Updated to show AE reporting details that include “(Northern Ireland)” to the United Kingdom information.
  • Section 7: Updated to remove “D-” from the zip code of the address of the MAH.
  • Section 10 Date of revision of the SmPC has also been updated to 16 December 2021 to align with the date of Positive Opinion.

Updated on 30 September 2020

File name

Mirapexin PR - Annex PIL text-EMEA-H-C-IAin-xxxx-IG_1601468551.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 06 March 2020

File name

Mirapexin PR - Annex PIL text - PSUSA-00002491-201904 _1583506464.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 06 March 2020

File name

M5pr-ALL-SPC-15 - Approved_1583504879.pdf

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 - 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 4.2: Addition of information related to dopamine agonist withdrawal syndrome under the ‘Treatment discontinuation’ sub-section.
  • Section 4.4: Update to information on risk factors related to dopamine agonist withdrawal syndrome under the ‘Dopamine agonist withdrawal syndrome (DAWS)’ sub-section.
  • Section 10: Date of revision has been updated 

Editorial update in section 4.8: the Irish Adverse Event reporting details have also been updated in section 4.8.

Updated on 12 August 2019

File name

PIL Text 2019-07-25 Additional Manufacturer Rottendorf_1565623669.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 27 June 2018

File name

N-87-annex text mirapexin-PR.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 04 May 2018

File name

Cropped for medicines.ie - AMT 85103 - PIL - 71177-13 - 18.04.18 - PIP012702-013.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 19 February 2018

File name

PIL_14514_563.pdf

Reasons for updating

  • New PIL for new product

Updated on 19 February 2018

Reasons for updating

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

Updated on 16 February 2018

Reasons for updating

  • New SPC for new product

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

Updated on 16 February 2018

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

The update follows completion of procedure EMEA/H/C/WS1318, a type IB variation to update to include a paragraph relating to dystonia in section 4.4 of the SmPC. This statement links to the most recent CCDS (0186-18) in which information on dystonia was added to the Special warnings and precautions section following a PRAC recommendation.

Section 4.8 has also been updated to include the current AE reporting details.

10 – Date of revision updated

Updated on 02 August 2017

Reasons for updating

  • Improved presentation of PIL

Updated on 21 July 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 18 July 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 (Special warnings and precautions) of the SPC. The statement had been inserted in error during the PSUR procedure, which received commission decision in February.


Section 10, date of revision of the text has also been updated to align with the revised date of commission decision which was 29/06/2017. Approved annex text became available on 07/07/2017.

Updated on 08 March 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 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 4.4 (Special warnings and precautions) has been updated to include a statement on DAWS and a statement on Dopamine dysregulation syndrome.

Section 4.8 (Undesirable effects) has been updated to include DAWS as a side effect with frequency unknown. In addition this section has been restructured.

Updated on 03 March 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 09 May 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 10 - Date of revision of the text
  • Change to joint SPC covering all presentations

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

Free text change information supplied by the pharmaceutical company

Minor editorial changes to section 4.2:

Heading of "Patients with renal impairment" amended to "Renal impairment"
Heading of "Patients with hepatic impairment" amended to "Hepaticimpairment"

"There is no relevant use of MIRAPEXIN prolonged-release tablets in the paediatric populication in Parkinson's Disease" amended to "There is no relevant use of MIRAPEXIN prolonged-release tablets in the paediatric populication for the indication of  Parkinson's Disease"

Section 4.4

the following paragraph was added:

Remnants in stool
Some patients have reported the occurrence of remnants in faeces which may resemble intact MIRAPEXIN prolonged-release tablets. If patients report such an observation, the physician should reassess patient’s response to therapy.

Section 10
Date of Revision updated.

Updated on 04 May 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to MA holder contact details

Updated on 21 November 2014

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details
  • Addition of information on reporting a side effect.

Updated on 04 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’ has been updated to include the addition of ‘delirium’ and ‘mania’ to the first paragraph (note - these side effects are already listed in Tables 1 and 2).  Plus, ‘Reporting of suspected adverse reactions’ details are now included.

 

Section 10 ‘Date of revision of the text’ has been updated from February 2014 to October 2014.

 

 

Updated on 18 March 2014

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 4.8 “Undesirable effects” and section 4.4 “Special warnings and precautions for use” have been updated to include “mania” and “delirium” as adverse drug reactions.  A new warning to inform healthcare professionals about the possibility of these events to occur under pramipexole treatment as well as the need for monitoring patients and dose adjustment has been added. 

Section 10 “Date of revision of the text” has been updated to February 2014.

Updated on 13 March 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 30 July 2013

Reasons for updating

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

Updated on 25 January 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation
  • Change to how the medicine works
  • Change to date of revision
  • Change to dosage and administration
  • Change to MA holder contact details
  • Change of special precautions for disposal

Updated on 19 December 2012

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

Section 4.8 has been updated to include inappropriate antidiuretic hormone secretion as an additional adverse reaction

Update to sections 4.4 and 4.8 regarding impulse control disorders.

In addition a number of minor editorial changes have been made to sections 2, 4.2, 4.3, 5.1, and 5.2. The date of revision of the text in section 10 has also been updated.

Updated on 01 August 2011

Reasons for updating

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

Updated on 13 July 2011

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 has been updated to include information relating to cardiac failure and amendments have been made in relation to the frequency information for some side effects

Section 10:
Date of revision of the text has also been updated.

Updated on 12 April 2011

Reasons for updating

  • Change of distributor details
  • Change to date of revision

Updated on 21 January 2011

Reasons for updating

  • Change to section 5.3 - Preclinical safety data
  • 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 5.3
Updated to include information concerning delayed sexual development observed in rats, the following statement has been added:
"'A delay in sexual development (i.e., preputial separation and vaginal opening) was observed in rats. The relevance for humans is unknown"

Section 7
A minor change has been made to the MA holder addres, 'Binger Straße 173' has been amended to 'Binger Strasse 173' to align with the commission annexes.

Section 10
Date of revision has been updated.

Updated on 11 January 2011

Reasons for updating

  • Change to instructions about missed dose
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 20 December 2010

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 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 4.2 - Inclusion of specific information on missed dose. Plus minor correction.

Section 4.5 - Update to include the results of an in depth evaluation of hOCT2 inhibitors

Section 4.6 - Revision of information on fertility

Section 4.8 - Update of information based on PSUR 13 to include new side effects and revise frequency categories

Section 10 - Update of revision date

Updated on 27 July 2010

Reasons for updating

  • Improved electronic presentation

Updated on 20 July 2010

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2 & 5.1
Information added regarding use in Paediatric population.

Section 10
Date of revision of text updated.

Updated on 14 July 2010

Reasons for updating

  • Change to MA holder contact details
  • Introduction of new strength

Updated on 02 July 2010

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

- Minor editorial changes to sections 4.1, 4.2, and 5.1

- Addition of paragraph to section 4.8 to align with the standard release tablets

- Reformatting of section 4.6 in line with current guidance

- Update of revision date to 17 June 2010 – section 10

Updated on 04 January 2010

Reasons for updating

  • New PIL for new product
  • New PIL for medicines.ie

Updated on 01 January 2010

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided