Hypovase 0.5 mg Tablets
- Name:
Hypovase 0.5 mg Tablets
- Company:
Pfizer Healthcare Ireland
- 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: 31/10/18
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Pfizer Healthcare Ireland
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 31 October 2018 PIL
Reasons for updating
- Change to section 6 - date of revision
Updated on 10 August 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
Updated on 10 August 2018 SPC
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 SPC
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 SPC
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 5 June 2015 PIL
Reasons for updating
- New PIL for new product
Updated on 5 June 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 2 October 2014 PIL
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 9 April 2014 SPC
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 4 April 2014 PIL
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 9 December 2009 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 18 September 2009 SPC
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 PIL
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 SPC
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 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 12 November 2007 SPC
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 3 April 2007 SPC
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 2 April 2007 PIL
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 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 11 December 2006 SPC
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 1 September 2006 PIL
Reasons for updating
- Improved electronic presentation
Updated on 30 August 2006 SPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 8 March 2006 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
- Change to side-effects
Updated on 6 May 2005 SPC
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 5 May 2005 PIL
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 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 27 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)