Hypovase 0.5 mg Tablets *

  • Company:

    Pfizer Healthcare Ireland
  • Status:

    No Recent Update
  • Legal 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

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 20 April 2021

File name

DEC202125802_Reg SPC HY 13_1 IE 0.5mg clean_1618929133.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_1618929055.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_1540995736.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_1533888973.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_1533889148.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

Updates to sections 4.6 & 5.3

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.

Additional wording regarding the 1 mg tablets – tablet can be split into equal halves.

Section 9
Date of renewal of authorisation

Date of renewal of authorisation

Section 10
Revision date

Revision date

Updated on 12 November 2007

Reasons for updating

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

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 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

3    – Pharmaceutical Form

         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)