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Dostinex 500 microgram Tablets

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Pharmacy Only: Prescription

Updated on 15 October 2024

File name

Reg SPC DX 13_0 IE clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 15 October 2024

File name

Reg PIL DX 16_0 IE clean.pdf

Reasons for updating

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

Updated on 13 February 2023

File name

DEC202073704_Reg SPC DX 12_2 IE-clean.pdf

Reasons for updating

  • Document format updated

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 05 November 2020

File name

DEC202073704_Reg PIL DX 15_0 IE-clean.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 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 04 November 2020

File name

DEC202073704_Reg SPC DX 12_2 IE-clean.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

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 04 November 2020

File name

DEC202073704_Reg PIL DX 15_0 IE-clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 04 November 2020

File name

DEC202073683_Reg PIL DX 18_0 UK-clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 29 October 2020

File name

Reg PIL DX 14_2 IE-clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder

Updated on 26 October 2015

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 26 October 2015

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: add an alternative container closure system

Updated on 22 October 2015

File name

PIL_10714_915.pdf

Reasons for updating

  • New PIL for new product

Updated on 22 October 2015

Reasons for updating

  • Change to date of revision
  • Introduction of new pack/pack size

Updated on 16 June 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

The reporting of adverse effects details changed from IMB to HPRA and minor editorial changes

Updated on 12 June 2015

Reasons for updating

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

Updated on 18 November 2014

Reasons for updating

  • Change to name of manufacturer

Updated on 18 February 2014

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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of renewal of authorisation

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Updates to sections 4.6, 4.7, 4.8. 5.1 & 9

Updated on 11 February 2014

Reasons for updating

  • Change to instructions about overdose
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability
  • Improved electronic presentation

Updated on 06 February 2013

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 – Impulse control disorders added
Section 4.8 - Impulse control disorders added

Updated on 01 February 2013

Reasons for updating

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

Updated on 13 April 2012

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 7: Marketing Authorisation Holder – Changed to Pfizer Healthcare Ireland
Section 8: Marketing Authorisation Number – Changed to PA 822/126/1

Updated on 10 April 2012

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Change to marketing authorisation holder
  • Change to MA holder contact details

Updated on 07 November 2011

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 7          Marketing Authorisation Holder change from Pharmacia Ireland Limited to Pharmacia Ireland

Section 10        Date of (Partial) Revision of the Text 

Updated on 25 October 2011

Reasons for updating

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

Updated on 18 March 2011

Reasons for updating

  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SmPC update Sections 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9 & 5.3 of the SPC

Updated on 17 March 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about driving or using machinery
  • Change to date of revision

Updated on 29 October 2010

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 14 May 2009

Reasons for updating

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

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2 – Restriction of maximum daily dose to 3mg

Section 4.3: Clarification of contraindication in patients with cardiac valvulopathy for long-term treatment with Dostinex

Clarification of contraindication in patients with cardiac valvulopathy for long-term treatment with Dostinex

Section 4.4: Clarification of warnings and precautions regarding pregnancy and use in long-term treatment with Dostinex

Clarification of warnings and precautions regarding pregnancy and use in long-term treatment with Dostinex

Section 4.8 Details of frequency of incidence of cardiac valvulopathy and related disorders included

Details of frequency of incidence of cardiac valvulopathy and related disorders included

Section 10: Date of revision updated

Date of revision updated

Updated on 08 May 2009

Reasons for updating

  • Change to date of revision
  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 28 April 2008

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

4.4 – addition of pathological gambling, increased libido and hypersexuality

4.8 – addition of pathological gambling, increased libido and hypersexuality 

10 – Date of revision of text updated

Updated on 28 April 2008

Reasons for updating

  • Change to side-effects

Updated on 13 March 2008

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 12 February 2007

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 4.5 - 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 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - MA number
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

Section 2: Additional information supplied re anhydrous lactose content

Section 4.2: Editing/typographical errors

Section 4.3: Information re galactose intolerance moved from section 4.4

Section 4.4: Sentence inserted to include warnings with regard to postural hypotension and fibrosis/valvulopathy paragraph included in text

Section 4.5: Change of heading

Section 4.6: Formatting of information

Section 4.8: Inhibition/suppression of lactation paragraph inserted and typographical errors corrected

Section 4.9: Formatting changes

Section 5.2: Formatting changes

Section 6.1: Formatting changes

Section 6.5: Line inserted

Section 6.6: Change of heading

Sections 8 and 9: Typographical and formatting changes

Section 10: Date of revision of text updated

Updated on 14 November 2006

Reasons for updating

  • Change of contraindications
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Improved electronic presentation

Updated on 31 July 2006

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 4.5 - 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 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sections 2 (anhydrous lactose content text inserted), 4.2 (typographical amendments), 4.3 (text inserted from section 4.4), 4.4 (text inserted to include complications for lactating women and fibrosis/valvulopathy complications), 4.5 (text inserted) 4.6 (text inserted and formatted), 4.8 (test inserted to include adverse events), 6.5 (text inserted) and 6.6 (text inserted to include disposal of medicinal product) of the SPC have been updated.

 

  

Updated on 31 July 2006

Reasons for updating

  • Change of active ingredient
  • Change of contraindications
  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to dosage and administration
  • Change to side-effects

Updated on 20 February 2006

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 20 February 2006

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 August 2005

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)