Hypovase 0.5 mg Tablets *
Pharmacy Only: Prescription

  • 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

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 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

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)