CARDURA TABLETS 2mg *

  • 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 2mg IE- clean_1606129934.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_1606129883.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_1602000642.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 2mg IE clean_1590731882.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_1590731855.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_1548766423.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 2mg IE.Clean_1548766477.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_1533048516.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 2mg Tablets IE Clean_2_1533048562.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 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 29 June 2017

Reasons for updating

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

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 29 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 19 June 2017

Reasons for updating

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

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 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 05 June 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 05 June 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 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

Section 4.4 Prostate cancer misdiagnosis warning added.

Updated on 04 January 2016

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Section 4.4 Prostate cancer misdiagnosis warning added.

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

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 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 09 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

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 09 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 02 July 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

None provided

Updated on 02 July 2013

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

None provided