MIRAPEXIN tablets

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Summary of Product Characteristics last updated on medicines.ie: 6/3/2020

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Boehringer Ingelheim Limited

Boehringer Ingelheim Limited

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Medicine Name Mirapexin prolonged-release tablets Active Ingredients Pramipexole dihydrochloride monohydrate
1 - 0 of 45 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 30 September 2020 PIL

Reasons for updating

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

Updated on 6 March 2020 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 6 March 2020

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

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 

Updated on 24 September 2019 PIL

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 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Change to name of medicinal product

Updated on 24 September 2019

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

· Sections 1, 2, 3 & 8: Removal of information related to ‘Mirapexin 1.1 mg tablets’ due to de-registration of the strength.

· Section 4.8: Editorial change to update the Irish AE reporting information.

· Section 10: Date of revision has been updated

​​

Updated on 27 June 2018 PIL

Reasons for updating

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

Updated on 4 May 2018 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 19 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 February 2018 PIL

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 SmPC for new product

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

Updated on 16 February 2018 SPC

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 28 July 2017 PIL

Reasons for updating

  • Change to other sources of information section
  • Improved presentation of PIL

Updated on 19 July 2017 PIL

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 18 July 2017 SPC

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 8 March 2017 SPC

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.1 - List of excipients
  • 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.

Minor editorial updates have been made to sections 4.5 and 6.1.

Updated on 3 March 2017 PIL

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 9 May 2016 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

Update to the European QRD template. All of the tablet strengths have been consolidated into one document.  A number of minor editorial revisions have been made in section 4.2.

Section 10, date of revision of the text has also been updated

Updated on 6 May 2016 PIL

Reasons for updating

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

Updated on 27 November 2014 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 3 November 2014 SPC

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

  • The change relates to an update to section 4.8 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. The date of revision has been updated accordingly.
  • Section 10 Date of revision of the text has also been updated to October 2014

Updated on 18 March 2014 SPC

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” to include mania and delirium as adverse drug reactions, and to add a new warning to inform healthcare professionals about the possibility of these events occurring under pramipexole treatment as well as the need for monitoring patients and dose adjustment.
• Section 10 Date of revision of the text has also been updated to February 2014

Updated on 13 March 2014 PIL

Reasons for updating

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

Updated on 23 July 2013 PIL

Reasons for updating

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

Updated on 21 January 2013 PIL

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 appearance of the medicine
  • Change to MA holder contact details

Updated on 19 December 2012 SPC

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, 4.8, 5.1, and 5.2. The date of revision of the text in section 10 has also been updated.

Updated on 1 August 2011 PIL

Reasons for updating

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

Updated on 13 July 2011 SPC

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 PIL

Reasons for updating

  • Change of distributor details
  • Change to date of revision

Updated on 19 January 2011 SPC

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 PIL

Reasons for updating

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

Updated on 17 December 2010 SPC

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 - 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 19 July 2010 SPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 4.2 - Posology and method of administration

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 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 8 July 2010 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • 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

- Update to sections 4.2, 4.4 and 5.1 to incorporate new clinical data relating to the Restless Legs indication.

- Minor editorial changes to sections 4.1, 4.2 and 5.1

- Reformatting of section 4.6 in line with current guidance

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

Updated on 26 November 2009 SPC

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 5.1 - Pharmacodynamic 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

Section 4.2 – Posology and method of administration

Dosing in patients with renal impairment

 

(i) Creatine clearance between 20 and 50 ml/min

 

The following information has been added: A maximum daily dose of 1.57 mg pramipexole base (2.25 mg of salt) should not be exceeded.

 

(ii) Creatinine clearance less than 20 ml/min

 

The following information has been added: A maximum daily dose of 1.1 mg pramipexole base (1.5 mg of salt) should not be exceeded.

 

 

Section 4.5 – Interaction with other medicinal products and other forms of interaction

Previous wording:

Inhibitors/competitors of active renal elimination pathway

“… medicinal products that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine and amantadine, may interact with pramipexole resulting in reduced clearance of either or both medicinal products…”

 

Updated wording:

 

Inhibitors/competitors of active renal elimination pathway

“… medicinal products that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine and amantadine, and mexiletine, may interact with pramipexole resulting in reduced clearance of either or both medicinal products…”

 

Section 5.1 – Pharmacodynamic properties

 

The following information has been added: In a clinical trial with healthy volunteers, where MIRAPEXIN prolonged-release tablets were titrated faster (every 3 days) than recommended up to 3.15 mg pramipexole base (4.5 mg of salt) per day, an increase in blood pressure and heart rate was observed. Such effect was not observed in patient studies.

 

Section 6.5 – Nature and contents of container

 

Previous wording

 

10 tablets per aluminium blister strips

Cartons containing 3 or 10 blister strips (30 or 100 tablets)

 

Updated wording

 

OPA/aluminium/PVC-aluminium blisters.

Each blister strip contains 10 tablets.

Cartons containing 3 or 10 blister strips (30 or 100 tablets).


Section 10 – Date of revision of the text

 

8 October 2009

 

Updated on 6 November 2009 PIL

Reasons for updating

  • Addition of joint PIL covering all presentations

Updated on 2 June 2009 PIL

Reasons for updating

  • Change to side-effects

Updated on 20 May 2009 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company



Section 4.8: Addition of dyspnoea (uncommon) and pneumonia (uncommon)

Updated on 18 March 2009 PIL

Reasons for updating

  • Change to side-effects
  • PIL retired pending re-submission

Updated on 4 March 2009 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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 for use)
 Formatting change. Behavioural changes such as compulsive shopping may occur.

Section 4.8 (Undesirable effects)
Addition of new side effects and frequencies, including compulsive shopping.

Updated on 10 October 2008 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients

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

Free text change information supplied by the pharmaceutical company

Reason for change

Change to section 4.8, 5.1 and 6.1

 

Main changes:

Section 4.8 Undesirable effects – this section has been rewritten. 

Updated on 22 August 2008 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 8 January 2008 SPC

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)

Free text change information supplied by the pharmaceutical company


Change is to section 10.

Updated on 2 November 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 27 October 2006 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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 the following information:

"Patients and caregivers should be aware of the fact that behavioural changes can occur (e.g. pathological gambling, increased libido, binge eating). Dose reduction/taper discontinuation should be considered."

Section 4.8:

Abnormal behaviour, abnormal dreams, delusions, hyperkinesias, increased eating (binge eating, hyperphagia), paranoia and weight increase have been added to the list of undesirable effects.

Updated on 12 June 2006 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 2 May 2006 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 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)

Updated on 6 July 2005 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

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

Updated on 16 November 2004 SPC

Reasons for updating

  • Change to marketing authorisation holder

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

Updated on 4 July 2003 SPC

Reasons for updating

  • New SPC for medicines.ie

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