Parlodel 2.5mg tablets

  • Name:

    Parlodel 2.5mg tablets

  • Company:
    info
  • Active Ingredients:

    Bromocriptine Mesilate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 24/01/19

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Summary of Product Characteristics last updated on medicines.ie: 21/12/2018

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Mylan IRE Healthcare Limited

Mylan IRE Healthcare Limited

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1 - 0 of 95 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 24 January 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 21 December 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 December 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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 June 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 6 June 2016 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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

In section 3: the description of the tablets has changed

In section 10: The date of revision has been changed.

Updated on 6 June 2016 PIL

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 3: the description of the tablets has changed

In section 10: The date of revision has been changed.

Updated on 20 January 2015 PIL

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.1: Information has been added with regards Parlodel not being recommended for the routine suppression of lactation or for relief of symptoms of post-partum pain and engorgement which can be adequately treated with non-pharmacological intervention

In section 4.2: A sub-heading of Posology has been added. Text has slightly changed with regards paediatric population and older people

In section 4.3: A contradiction has been added with regards suppression of lactation. Two contradictions have been removed; coronary artery disease and other severe cardiovascular conditions and symptoms and/or a history of serious physic disorders

In section 4.4: Reference to monitoring of blood pressure especially in the first few days of therapy has been added. Text in reference to elderly patients have changed to older people.

In section 4.6: Fertility has been added to the heading and as a sub-section

In section 4.8: Adverse reaction reporting statement has been added

In section 10: date of revision has changed

Updated on 20 January 2015 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.6 - Pregnancy and lactation
  • 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

In section 4.1: Information has been added with regards Parlodel not being recommended for the routine suppression of lactation or for relief of symptoms of post-partum pain and engorgement which can be adequately treated with non-pharmacological intervention

In section 4.2: A sub-heading of Posology has been added. Text has slightly changed with regards paediatric population and older people

In section 4.3: A contradiction has been added with regards suppression of lactation. Two contradictions have been removed; coronary artery disease and other severe cardiovascular conditions and symptoms and/or a history of serious physic disorders

In section 4.4: Reference to monitoring of blood pressure especially in the first few days of therapy has been added. Text in reference to elderly patients have changed to older people.

In section 4.6: Fertility has been added to the heading and as a sub-section

In section 4.8: Adverse reaction reporting statement has been added

In section 10: date of revision has changed

Updated on 13 November 2014 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • 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

In section 6.4: Reference to the 100 pack size and the 500 pack size has been removed.
 In section 6.5: Also reference to storage conditions of the bottle have been removed.

In section 10: the date of revision has changed

Updated on 13 November 2014 PIL

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 6.4: Reference to the 100 pack size and the 500 pack size has been removed.
 In section 6.5: Also reference to storage conditions of the bottle have been removed.

In section 10: the date of revision has changed

Updated on 13 June 2014 PIL

Reasons for updating

  • 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 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.3: Long-term treatment: Evidence of cardiac valvulopathy is now contraindicated.

In section 4.4: Information regarding impulse control disorders has been added as a special warning and precaution. Further information regarding use in children and adolescents (aged 7 to 17) and the elderly has been added.

In section 4.8: Additional very rare psychiatric disorder adverse reactions have been added. Additional very rare cardiac disorder adverse reactions has been added. Additional warnings of impulse control disorders have been added to this section. Reporting of adverse reactions to the IMB have been added.

In section 4.9: Reported isolated reports of children ingesting Parlodel has been added to signs and symptoms of overdose

In section 10: Date of revision has changed to June 2014

Updated on 13 June 2014 SmPC

Reasons for updating

  • 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 4.9 - Overdose
  • 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

In section 4.3: Long-term treatment: Evidence of cardiac valvulopathy is now contraindicated.

In section 4.4: Information regarding impulse control disorders has been added as a special warning and precaution. Further information regarding use in children and adolescents (aged 7 to 17) and the elderly has been added.

In section 4.8: Additional very rare psychiatric disorder adverse reactions have been added. Additional very rare cardiac disorder adverse reactions has been added. Additional warnings of impulse control disorders have been added to this section. Reporting of adverse reactions to the IMB have been added.

In section 4.9: Reported isolated reports of children ingesting Parlodel has been added to signs and symptoms of overdose

In section 10: Date of revision has changed to June 2014

Updated on 13 November 2012 PIL

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company



In section 3: Information regarding the description of the tablet has changed

In section 6.1: Pregelatinised Maize Starch has been removed from the excipients

In section 7: the address of the MA has been updated

In section 9: the date of last renewal has been revised

In section 10: the revision date has changed

Updated on 13 November 2012 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 7 - Marketing authorisation holder
  • 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)

Free text change information supplied by the pharmaceutical company



In section 3: Information regarding the description of the tablet has changed

In section 6.1: Pregelatinised Maize Starch has been removed from the excipients

In section 7: the address of the MA has been updated

In section 9: the date of last renewal has been revised

In section 10: the revision date has changed

Updated on 25 February 2008 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Section 7-removal of the trading style of the Marketing Authorisation holder.

Updated on 25 February 2008 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Section 7-removal of the trading style of the Marketing Authorisation holder.

Updated on 4 October 2007 PIL

Reasons for updating

  • Change to marketing authorisation holder

Free text change information supplied by the pharmaceutical company

MAH changed from

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley

Surrey  GU16 7SR

UK
 
 to
 

Meda Health Sales Ireland Limited

Office 10, Dunboyne Business Park

Dunboyne

Co Meath

Ireland

 

Trading as:

 

Meda Pharma
 
and PA number changed from
PA13/2/1
TO

PA 1332/16/1

Updated on 4 October 2007 SmPC

Reasons for updating

  • Change to marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

MAH changed from

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley

Surrey  GU16 7SR

UK
 
 to
 

Meda Health Sales Ireland Limited

Office 10, Dunboyne Business Park

Dunboyne

Co Meath

Ireland

 

Trading as:

 

Meda Pharma
 
and PA number changed from
PA13/2/1
TO

PA 1332/16/1

Updated on 13 July 2006 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Changes to Sections 2, 3, 6.4, 6.5, 9 and 10 due to renewal.

Updated on 13 July 2006 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • 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)

Free text change information supplied by the pharmaceutical company

Changes to Sections 2, 3, 6.4, 6.5, 9 and 10 due to renewal.

Updated on 13 December 2005 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 13 December 2005 PIL

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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

Updated on 13 December 2005 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 13 December 2005 SmPC

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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

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

Updated on 17 November 2005 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.1 - Therapeutic indications
  • 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 10 - Date of revision of the text

Updated on 17 November 2005 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.1 - Therapeutic indications
  • 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 10 - Date of revision of the text

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

Updated on 17 February 2005 SmPC

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 17 February 2005 PIL

Reasons for updating

  • Change to section 10 - Date of revision of the text

Updated on 9 November 2004 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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

Updated on 9 November 2004 PIL

Reasons for updating

  • Change to section 3 - Pharmaceutical form

Updated on 7 November 2003 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 7 November 2003 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 4 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 4 June 2003 PIL

Reasons for updating

  • New SPC for medicines.ie