Dostinex 500 microgram Tablets
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
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
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
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 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
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 DostinexSection 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 DostinexSection 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 includedSection 10: Date of revision updated
Date of revision updatedUpdated 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
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)