CARDURA XL 4MG Prolonged-release tablets *

  • 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 08 April 2021

File name

DEC202104982-V_Reg SPC CX 26_1 4mg IE - clean_1617894258.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)

Updated on 08 April 2021

File name

DEC202104982-V_Reg PIL CX 32_1 IE - clean_1617894195.pdf

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

File name

DEC202021610_Reg PIL CX 31_1 IE-clean_1585891316.pdf

Reasons for updating

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

Updated on 13 February 2020

File name

DEC202009708_Reg SPC CX 25_2 4mg IE-clean_1581602322.pdf

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

File name

DEC202009708_Reg PIL CX 30_2 IE-clean_1581602242.pdf

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

File name

DEC201907801_Reg PIL CX 28_0 IE-clean_1550586130.pdf

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

File name

DEC201907801_Reg SPC CX 24_0 4mg IE-clean_1550585941.pdf

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

File name

Reg PIL CX 27_2 IE.Clean_1541595596.pdf

Reasons for updating

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

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 19 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

File name

PIL_8752_55.pdf

Reasons for updating

  • New PIL for new product

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 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 18 February 2016

Reasons for updating

  • Change of contraindications

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 22 October 2015

Reasons for updating

  • Change to side-effects
  • Change to improve clarity and readability
  • Correction of spelling/typing errors

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 05 June 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • 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 03 June 2013

Reasons for updating

  • Improved electronic presentation

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

  • 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

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 05 April 2013

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 14 August 2012

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 extended to 3 years

Updated on 27 April 2010

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

Section 3 -Updated to change the wording “For excipients, see 6.1”    to “For a full list of excipients see section, 6.1.”

Section 6.4 Updated to change the wording   “Store in the original package” to “Store in the original package in order to protect from moisture

Updated on 10 December 2009

Reasons for updating

  • Change due to user-testing of patient information

Updated on 13 November 2009

Reasons for updating

  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

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 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, impaired renal function, hepatic impairment and use with PDE-5 inhibitors

Section 4.5 – Updated to include a statement that data from formal drug/drug interaction studies are not present. This section has alos been re-ordered.

Section 4.6 – 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

Section 4.8 – 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 on 09 November 2009

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

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 04 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

Updated on 04 September 2007

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 03 May 2007

Reasons for updating

  • Change of inactive ingredient

Updated on 12 March 2007

Reasons for updating

  • Change to section 6.1 - List of excipients

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

Free text change information supplied by the pharmaceutical company

Section 6.1 has been updated to include a new ink component – propylene glycol.

Updated on 28 November 2005

Reasons for updating

  • Change of manufacturer

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
  • Change to section 4.8 - Undesirable effects
  • Change to section 3 - Pharmaceutical form
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
  • Change to section 9 - Date of renewal of authorisation

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 04 October 2004

Reasons for updating

  • Change of manufacturer

Updated on 16 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 02 August 2004

Reasons for updating

  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 7 - Marketing authorisation holder
  • 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)