Parlodel 5mg capsules
- Name:
Parlodel 5mg capsules
- Company:
Mylan IRE Healthcare Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/12/18
(Click to Download)Click on this link to Download PDF directly
Mylan IRE Healthcare Limited
Company Products
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 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 21 January 2015 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 21 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 21 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 12 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 12 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 26 July 2012 PIL
Reasons for updating
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated on 26 July 2012 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)
Free text change information supplied by the pharmaceutical company
Updated on 15 March 2011 PIL
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 10: the date of revision has changed to Feb 2011
Updated on 15 March 2011 SmPC
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
In section 10: the date of revision has changed to Feb 2011
Updated on 17 January 2011 PIL
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 4.2 - 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 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 2: Addition of text 'For a full list of excipients, see section 1
In section 2; description of capsules have changed
In section 4.2: Additionally text added 'Initially half a tablet',
In section 4.4: Text has been removed in relation to pathological gambling etc
In section 4.8: Text has been removed in relation to class effects
In section 6.1: Composition of printing ink has changed
In section 6.3: shelf life has changed from 4 years to 3 years
In section 6.4: Addition storage precautions have been added
In section 7: Text 'Trading as' removed
In section 10: date of revision has changed
Updated on 17 January 2011 SmPC
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 4.2 - 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 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- 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
In section 2: Addition of text 'For a full list of excipients, see section 1
In section 2; description of capsules have changed
In section 4.2: Additionally text added 'Initially half a tablet',
In section 4.4: Text has been removed in relation to pathological gambling etc
In section 4.8: Text has been removed in relation to class effects
In section 6.1: Composition of printing ink has changed
In section 6.3: shelf life has changed from 4 years to 3 years
In section 6.4: Addition storage precautions have been added
In section 7: Text 'Trading as' removed
In section 10: date of revision has changed
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
Novartis Pharmaceuticals UK Limited
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
Meda Health Sales Ireland Limited
Office 10,
Dunboyne
Co Meath
Trading as:
Updated on 4 October 2007 PIL
Reasons for updating
- Change to marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Novartis Pharmaceuticals UK Limited
Frimley Business Park
Frimley
Camberley
Surrey GU16 7SR
Meda Health Sales Ireland Limited
Office 10,
Dunboyne
Co Meath
Trading as:
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 4.4 - 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 4.4 - 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 10 August 2004 SmPC
Reasons for updating
- Change to section 5.3 - Preclinical safety data
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 10 August 2004 PIL
Reasons for updating
- Change to section 5.3 - Preclinical safety data
Updated on 4 June 2003 PIL
Reasons for updating
- New SPC for medicines.ie
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)