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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: 13/08/2009
SPC CARDURA TABLETS 1mg; CARDURA TABLETS 2mg

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 13/08/2009 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
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   07-Aug-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 – Updated to include hypotension, a history of orthostatic hypotension and BPH patients with urinary tract problems or bladder stones as additional contra-indications

Section 4.4 – Updated to amend the wording of the warnings for patients with acute cardiac conditions, hepatic impairment and use with PDE-5 inhibitors

– Updated to amend the wording of the warnings for patients with acute cardiac conditions, hepatic impairment and use with PDE-5 inhibitors

Section 4.5 – Updated to include the addition of PhVWP wording on the co-administration of non-selective alpha blockers and PDE-5 Inhibitors

 – Updated to include the addition of PhVWP wording on the co-administration of non-selective alpha blockers and PDE-5 Inhibitors

Section 4.6 – Updated to included additional information on the use of Cardura in pregnancy and lactation

 – Updated to included additional information on the use of Cardura in pregnancy and lactation

Section 4.7 – Amended the wording around on the ability to drive and operate machinery

 – Amended the wording around on the ability to drive and operate machinery

Section 4.8 – Updated to include additional side effects and amended frequencies to be in line with the CSP.

 – Updated to include additional side effects and amended frequencies to be in line with the CSP.

Section 4.9 – Updated to provide further details on treatment of overdose

 – Updated to provide further details on treatment of overdose
Updated on 12/05/2009 and displayed until 13/08/2009
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   01-May-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Update to section 4.5 of the SPC with the INN nomenclature for indometacin and furosemide
Updated on 29/11/2007 and displayed until 12/05/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   09/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.8 – addition of retrograde ejaculation 
Updated on 24/08/2007 and displayed until 29/11/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   02/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Update to section 4.4 of the SPC to include Intraoperative Floppy Iris Syndrome (IFIS) warnings as requested by the Pharmacovigilance Working Party (PhVWP).
Updated on 05/03/2007 and displayed until 24/08/2007
Reasons for adding or updating:
  • Change from BAN to rINN
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   02/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.5 - Change to use INN nomenclature for indometacin and furosemide
Updated on 12/02/2007 and displayed until 05/03/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 6.2 - Incompatibilities
Date of revision of text on the SPC:   10/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Sections 4.2, 4.4, 6.2 - minor administrative amendments and Section 4.4  - advice relating to the excipient lactose has also been added.
Updated on 05/01/2006 and displayed until 12/02/2007
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
  • Change to section 10 (date of (partial) revision of the text
Updated on 04/01/2006 and displayed until 05/01/2006
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
  • Change to section 10 (date of (partial) revision of the text
  • Pending awaiting re-submission
Updated on 19/11/2003 and displayed until 04/01/2006
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5 - Pharmacological Properties
  • Change to section 10 (date of (partial) revision of the text
Updated on 23/08/2001 and displayed until 19/11/2003
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 22/08/2001 and displayed until 23/08/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 22/03/2000 and displayed until 22/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 04/02/2000 and displayed until 22/03/2000
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

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