Hypovase 0.5 mg Tablets
*Company:
Pfizer Healthcare IrelandStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 13 March 2024
File name
Reg SPC HY 14 1 IE 0.5mg - clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 13 March 2024
File name
Reg PIL HY 16 1 IE clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 6 - date of revision
Updated on 13 February 2023
File name
DEC202125802_Reg SPC HY 13_1 IE 0.5mg clean.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 31 August 2022
File name
RegPILHY151IEclean (1).pdf
Reasons for updating
- Change to section 3 - dose and frequency
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Removal of one or more presentations from joint PIL
- Correction of spelling/typing errors
Updated on 20 April 2021
File name
DEC202125802_Reg SPC HY 13_1 IE 0.5mg 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 be renewed (B)
Updated on 20 April 2021
File name
DEC202125802_Reg PIL HY 14_2 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 - what the product contains
- Change to section 6 - date of revision
Updated on 31 October 2018
File name
Reg PIL HY 13_0 IE-clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 10 August 2018
File name
Reg PIL HY 13_0 IE-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
Updated on 10 August 2018
File name
Reg SPC HY 12_0 IE 0.5mg-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The SPC is updated as follows:
Section 7 has been updated from Current MAH Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Subsequently section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number.
Updated on 11 June 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 11 June 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows;
Update to section 4.4 in line with CDS to add warning of priapism.
Updated on 05 June 2015
File name
PIL_8754_206.pdf
Reasons for updating
- New PIL for new product
Updated on 05 June 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 02 October 2014
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 09 April 2014
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 04 April 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to further information section
- Change to date of revision
Updated on 09 December 2009
Reasons for updating
- Change due to user-testing of patient information
Updated on 18 September 2009
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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4
Additional warning regarding concomitant use of PDE-5 inhibitors and prazosin hydrochloride.
Section 4.5
Addition of interaction regarding concomitant use of PDE-5 Inhibitors and prazosin hydrochloride which may lead to symptomatic hypotension in some patients
Updated on 15 September 2009
Reasons for updating
- Change to warnings or special precautions for use
- Change to drug interactions
- Change to date of revision
Updated on 26 May 2009
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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
Section 2
Revised wording regarding list of excipients.
Section 3
Additional wording regarding the 1 mg tablets – tablet can be split into equal halves.
Section 9
Date of renewal of authorisation
Section 10
Revision date
Updated on 12 November 2007
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 special precautions for use
Warning regarding the observation of ‘Intraoperative Floppy Iris Syndrome’ (IFIS, a variant of small pupil syndrome) during cataract surgery in some patients on or previously treated with tamsulosin.
Section 10 – Date of Revision of Text
Change to March 2007
Updated on 12 November 2007
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 03 April 2007
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to the description of the tablet; colour, bossing and dimensions.
6.1 – List if Excipients
Removal of reference to “sunset yellow (E110)”
6.5 – Nature and Contents of Container
Change to the composition of the blister
Change in the pack size
Updated on 02 April 2007
Reasons for updating
- Change of manufacturer
- Change to appearance of the medicine
- Change to packaging
- Addition of marketing authorisation holder
- Change due to harmonisation of patient information leaflet
Updated on 21 December 2006
Reasons for updating
- Change to MA holder contact details
Updated on 11 December 2006
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.2 – Posology and Method of Administration
Removal of all reference to the starter pack.
6.5 – Nature and Contents of Container
Removal of all reference to the starter pack.
Updated on 01 September 2006
Reasons for updating
- Improved electronic presentation
Updated on 30 August 2006
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 08 March 2006
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
- Change to side-effects
Updated on 06 May 2005
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- 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)
Updated on 05 May 2005
Reasons for updating
- Change of active ingredient
- Change of active ingredient
- Change of inactive ingredient
- Change to packaging
- Change to date of revision
Updated on 17 September 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 27 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)