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Pfizer Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 07/09/2009
SPC Hypovase Tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 07/09/2009 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   01-Jun-2009
Legal Category:   POM
Black Triangle (CHM):   NO

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

and prazosin hydrochloride which may lead to symptomatic hypotension in some patients
Updated on 03/09/2007 and displayed until 07/09/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   08/2007
Legal Category:   POM
Black Triangle (CHM):   NO

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

Changed to August 2007
Updated on 05/06/2007 and displayed until 03/09/2007
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 

2 –    Qualitative and Quantitative Composition

         Formatting

3 –    Pharmaceutical Form

         Change in description of tablets

4.1 – Therapeutic indications

         Formatting

4.2 – Posology and method of administration

         Formatting and     

         Removal of reference to the b.d. starter pack

6.1 – List if Excipients

         Removal of reference to “sunset yellow (E110)”

6.5 – Nature and Contents of Container

         Removal of reference to the starter pack and Hypovase 2 mg tablets

         Change in the pack size and

         Addition of information regarding container material

6.6 – Instructions for use, handling and disposal

         Revised sentence according to guidelines.

10 –  Date of (Partial) Revision of the Text
Updated on 20/09/2006 and displayed until 05/06/2007
Reasons for adding or updating:
  • Change to joint SPC covering all presentations
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 
Removal of the 2 mg presentation from the joint SPC.
Updated on 04/04/2006 and displayed until 20/09/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 10 (date of (partial) revision of the text
Updated on 26/01/2005 and displayed until 04/04/2006
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 4.3 - Contra-indications
  • Change to section 4.8 - Undesirable Effects
Updated on 22/08/2001 and displayed until 26/01/2005
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 04/02/2000 and displayed until 22/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 04/02/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  prazosin hydrochloride