CARDURA TABLETS 1MG *

  • 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 23 November 2020

File name

DEC202050686-V_Reg SPC CR 27_2 1mg IE- clean_1606129830.pdf

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

File name

DEC202050686-V_Reg PIL CR 32_2 IE- clean_1606129761.pdf

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 06 October 2020

File name

Reg PIL CB 26_0 IE clean_1602000510.pdf

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

File name

DEC202035403_Reg SPC CR 26_0 1mg IE clean_1590731815.pdf

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

File name

DEC202035403_Reg PIL CR 29_0 IE clean_1590731747.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 29 January 2019

File name

DEC201904204_Reg PIL CR 28_0 IE.Clean_1548766070.pdf

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

File name

DEC201904204_Reg SPC CR 25_0 1mg IE. Clean_1548766332.pdf

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

File name

Reg PIL CR 26_1 PIL Clean IE_2_1533048473.pdf

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

File name

Reg SPC CR 24_1 1mg Tablets IE Clean_1533048429.pdf

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

File name

PIL_9044_384.pdf

Reasons for updating

  • New PIL for new product

Updated on 29 January 2018

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 04 September 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 04 September 2017

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

Lactation information in section 4.6 was updated in line with the CDS.  Section 5.3 was also updated in line with the WRS SPC.

Updated on 20 June 2017

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

The SPC has been updated as follows: Section 4.4 has been updated with the priapism warning.  Formatting corrections have been made throughout the SPCs.  For Cardura Section 5.1 has also been corrected to remove the ATC code G04CA05 for benign prostatic hyperplasia.

Updated on 15 June 2017

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

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 04 January 2016

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

Reasons for updating

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

Updated on 26 October 2015

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 & 6.6

Updated on 23 October 2015

Reasons for updating

  • Change of contraindications

Updated on 11 June 2015

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 05 June 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to improve clarity and readability
  • Correction of spelling/typing errors

Updated on 02 October 2014

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 02 July 2013

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

Update to section 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1

Updated on 28 June 2013

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 09 December 2009

Reasons for updating

  • Change due to user-testing of patient information

Updated on 27 August 2009

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 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 13 August 2009

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 02 July 2008

Reasons for updating

  • Change to name of manufacturer

Updated on 25 March 2008

Reasons for updating

  • Change to side-effects

Updated on 19 March 2008

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 05 February 2008

Reasons for updating

  • Change of inactive ingredient

Updated on 04 February 2008

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 04 September 2007

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 03 September 2007

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

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

Reasons for updating

  • Change to appearance of the medicine
  • Change to date of revision

Updated on 19 April 2006

Reasons for updating

  • Change to dosage and administration
  • Change to date of revision

Updated on 19 April 2006

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

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 16 August 2005

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

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

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

Reasons for updating

  • New PIL for medicines.ie

Updated on 10 June 2004

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

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)