CARDURA XL 8mg Prolonged-release tablets
*Company:
Upjohn EESVStatus:
No Recent UpdateLegal 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
Updated on 12 February 2024
File name
Patient Information Leaflet - 003034543_clean_version 4.0.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 12 February 2024
File name
Patient Information Leaflet - 003034543_clean_version 4.0.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 12 February 2024
File name
Patient Information Leaflet - 003034543_clean_version 4.0.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 24 August 2022
File name
DEC202209911-V_Reg SPC CX 27_1 8mg IE - clean.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 - Pfizer Healthcare Ireland changed to Viatris Healthcare Limited as the MAH, with updated address
Section 8 - updated with new PA number for Viatris Healthcare Limited
Updated on 24 August 2022
File name
DEC202209911-V_Reg PIL CX 33_0 IE - clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 08 April 2021
File name
DEC202104982-V_Reg SPC CX 26_1 8mg IE - clean.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.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.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 8mg IE-clean.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.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.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 8mg IE-clean.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.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
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
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
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
Updated on 15 June 2017
File name
PIL_8752_55.pdf
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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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
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 populationUpdated 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 populationUpdated 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
Updated on 30 October 2014
Reasons for updating
- Improved electronic presentation
Free text change information supplied by the pharmaceutical company
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
Updated on 16 April 2013
Reasons for updating
- Change to section 6.3 - Shelf life
Free text change information supplied by the pharmaceutical company
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
Updated on 09 April 2013
Reasons for updating
- New individual SPC (was previously included in combined SPC)