CARDURA TABLETS 1MG
- Name:
CARDURA TABLETS 1MG
- 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: 23/11/20

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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 23 November 2020 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 2 – details on 'Sodium' was deleted in line with EU excipient guidance.
Section 4.4 – subheading ‘Excipient information’ was added above the information for Sodium, and minor amendments made to the text.
Section 4.8 – ADR reporting information updated in line with new HPRA ADR reporting
Updated on 23 November 2020 PIL
Reasons for updating
- 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 6 October 2020 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 29 May 2020 SPC
Reasons for updating
- Change to section 4.3 - Contraindications
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:
Under section 4.3 Delete point '4. During lactation (see section 4.6)'.
Updated on 29 May 2020 PIL
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 29 January 2019 PIL
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 29 January 2019 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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: Sections 2 and 4.4 updated to reflect the sodium excipient content.
Updated on 31 July 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 31 July 2018 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
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: 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 29 January 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 29 January 2018 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 4 September 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 4 September 2017 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 20 June 2017 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 15 June 2017 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 31 May 2017 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 4 January 2016 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
Section4.4 Prostate cancer misdiagnosis warning added.
Updated on 29 December 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 26 October 2015 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 6.6 - Special precautions for disposal and other handling
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:
Paediatric Wording
Section 4.2
QRD/Editorial
Sections 4.8 & 6.6Updated on 23 October 2015 PIL
Reasons for updating
- Change of contraindications
Updated on 11 June 2015 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
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:
SPC section 4.4 – Addition of a warning relating to priapism.
Typographical corrections & QRD Template v9 Updates - SPC sections 1 / 2 / 4.2 / 4.3 / 4.4 / 4.5 / 4.6 / 4.8 / 5.1 / 5.2 / 5.3 / 6.5 / 6.6 / 9
Updated on 5 June 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to improve clarity and readability
- Correction of spelling/typing errors
Updated on 2 October 2014 PIL
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 2 July 2013 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 28 June 2013 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 9 December 2009 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 27 August 2009 SPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.9 - Overdose
- Change to section 4.3 - Contraindications
- 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 4.4 - 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
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 inhibitorsSection 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 InhibitorsSection 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 lactationSection 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 machinerySection 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 overdoseUpdated on 13 August 2009 PIL
Reasons for updating
- Change to drug interactions
- Change to date of revision
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
Updated on 2 July 2008 PIL
Reasons for updating
- Change to name of manufacturer
Updated on 25 March 2008 PIL
Reasons for updating
- Change to side-effects
Updated on 19 March 2008 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.8 – addition of retrograde ejaculation
Updated on 5 February 2008 PIL
Reasons for updating
- Change of inactive ingredient
Updated on 4 February 2008 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6 - Pharmaceutical particulars
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
2. Updated in line with current requirements
6. Minor formatting changes
6.6 Change in title of section in line with current requirements
Updated on 4 September 2007 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 3 September 2007 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
Section 4.4 – Addition of warning related to cataract surgery and incidence of IFIS
Updated on 21 April 2006 SPC
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 21 April 2006 PIL
Reasons for updating
- Change to appearance of the medicine
- Change to date of revision
Updated on 19 April 2006 PIL
Reasons for updating
- Change to dosage and administration
- Change to date of revision
Updated on 19 April 2006 SPC
Reasons for updating
- Change to section 3 - Pharmaceutical form
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 16 August 2005 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 16 August 2005 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)
Updated on 15 April 2005 SPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- 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)
Updated on 15 April 2005 PIL
Reasons for updating
- Change of contraindications
- Change to warnings or special precautions for use
- Change to side-effects
- Change to information about driving or using machinery
- Change of inactive ingredient
- Change to storage instructions
Updated on 22 December 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 10 June 2004 SPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 26 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)