CARDURA XL 8mg Prolonged-release tablets
- Name:
CARDURA XL 8mg Prolonged-release tablets
- Company:
Pfizer Healthcare Ireland
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/04/21
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Pfizer Healthcare Ireland
Company Products
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 8 April 2021 SPC
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 8 April 2021 PIL
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 3 April 2020 PIL
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 13 February 2020 SPC
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 PIL
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 PIL
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 SPC
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 7 November 2018 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 4 September 2017 SPC
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 4 September 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 4 September 2017 PIL
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 SPC
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 PIL
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 PIL
Reasons for updating
- New PIL for new product
Updated on 25 May 2017 PIL
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 25 May 2017 SPC
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 19 February 2016 SPC
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 PIL
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 SPC
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 PIL
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 9 June 2015 SPC
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 9 June 2015 PIL
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 SPC
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 PIL
Reasons for updating
- Improved electronic presentation
Free text change information supplied by the pharmaceutical company
Updated on 16 April 2013 PIL
Reasons for updating
- Change to section 6.3 - Shelf life
Free text change information supplied by the pharmaceutical company
Updated on 16 April 2013 SPC
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 9 April 2013 SPC
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 9 April 2013 PIL
Reasons for updating
- New individual SPC (was previously included in combined SPC)