CARDURA XL 8mg Prolonged-release tablets

Product Information *

  • Company:

    Pfizer Healthcare Ireland
  • Status:

    No Recent Update
  • Active Ingredients * :

    *Additional information is available upon request

  • Legal Category:

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

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 08 April 2021

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)

Updated on 08 April 2021

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 03 April 2020

Reasons for updating

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

Updated on 13 February 2020

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 follow: Section 4.1 -indication of benign prostatic hyperplasia added’, ‘Section 4.4- Screening for Prostate Cancer added’ and ‘Section 5.1 – text added regarding benign prostatic hyperplasia

Updated on 13 February 2020

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 19 February 2019

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 19 February 2019

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 9 - Date of first authorisation/renewal of the 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

The SPC has been updated in sections 2, 3, 4.3, 4.4, 9 and 10 of the SPC in line with CDS and QRD to reflect work sharing procedure DE/H/xxxx/WS 535

Updated on 07 November 2018

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

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 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

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 19 June 2017

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • 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: 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 19 June 2017

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.4 - Special warnings and precautions for use

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

  • New PIL for new product

Updated on 25 May 2017

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Sections 4.5 and 5.2 have been updated in-line with the CDS

Updated on 25 May 2017

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic 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: Sections 4.5 and 5.2 have been updated in-line with the CDS

Updated on 19 February 2016

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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 4.2 Updated wording with respect to the paediatric population

Updated on 19 February 2016

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.2 Updated wording with respect to the paediatric population

Updated on 26 October 2015

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 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

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:

GI Obstruction:

Section 4.8

QRD/Editorial:

Sections 1 / 2 / 3 / 4.1 / 4.2 / 4.3 / 4.4 / 4.5 / 4.6 / 4.8 / 5.1 / 5.2 / 5.3 / 6.5 / 6.6.

Updated on 26 October 2015

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

GI Obstruction:

Section 4.8

QRD/Editorial:

Sections 1 / 2 / 3 / 4.1 / 4.2 / 4.3 / 4.4 / 4.5 / 4.6 / 4.8 / 5.1 / 5.2 / 5.3 / 6.5 / 6.6.

Updated on 09 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:

SPC section 4.4 – Addition of a warning relating to priapism.

Updated on 09 June 2015

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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.

Updated on 30 October 2014

Reasons for updating

  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

improved electronic presentation

Updated on 30 October 2014

Reasons for updating

  • Improved electronic presentation

Free text change information supplied by the pharmaceutical company

improved electronic presentation

Updated on 16 April 2013

Reasons for updating

  • Change to section 6.3 - Shelf life

Free text change information supplied by the pharmaceutical company

Section 6.3 Shelf-life changed to 3 years

Updated on 16 April 2013

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Section 6.3 Shelf-life changed to 3 years

Updated on 09 April 2013

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

Update to section 4.3, 4.4, 4.5,4.6 & 4.8

Updated on 09 April 2013

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Free text change information supplied by the pharmaceutical company

Update to section 4.3, 4.4, 4.5,4.6 & 4.8