Detrusitol SR 2 mg, prolonged-release, hard;
- Name:
Detrusitol SR 2 mg, prolonged-release, hard;
- 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: 21/04/21
(Click to Download)Click on this link to Download PDF directly
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 21 April 2021 SPC
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 Upjohn EESV as the MAH, with updated address Section 8 - updated with new PA number for Upjohn EESV
|
Updated on 21 April 2021 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 2 March 2021 SPC
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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 as follows: Capsules - Section 2: Excipient heading added Tablets |
Updated on 2 March 2021 PIL
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - excipient warnings
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 15 January 2021 SPC
Reasons for updating
- Change to section 6.4 - Special precautions for storage
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 15 January 2021 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 31 July 2015 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 31 July 2015 SPC
Reasons for updating
- 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 4.8 Reporting of suspected adverse reactions – QRD text added.
Updated on 28 July 2015 PIL
Reasons for updating
- New PIL for new product
Updated on 28 July 2015 PIL
Reasons for updating
- Change to side-effects
Updated on 17 February 2012 PIL
Reasons for updating
- PIL re-instated
Updated on 23 January 2012 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 21 October 2011 SPC
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
Updated on 18 October 2011 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 27 September 2011 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 10 November 2010 SPC
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 8 November 2010 PIL
Reasons for updating
- Change to date of revision
- Introduction of new pack/pack size
Updated on 29 July 2010 PIL
Reasons for updating
- Change of manufacturer
Updated on 18 February 2009 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 11 December 2008 SPC
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
Section 4.8 has been updated to include the most common side effects with the tabulated listing.
Updated on 10 December 2008 PIL
Reasons for updating
- Change to side-effects
Updated on 15 July 2008 PIL
Reasons for updating
- Change to drug interactions
- Change to side-effects
Updated on 15 July 2008 SPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
Section 4.5 has been updated to include an additional CYP2D6 enzyme.
Section 4.8 has been update to add a number of additional side effects.
Updated on 7 December 2007 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
7.0 – Marketing Authorisation Holder (Address)
Updated on 7 December 2007 PIL
Reasons for updating
- Change to marketing authorisation holder address
Updated on 14 June 2007 SPC
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
Updated on 14 June 2007 PIL
Reasons for updating
- Change to side-effects
Updated on 20 April 2007 PIL
Reasons for updating
- Change due to harmonisation of patient information leaflet
Updated on 17 April 2007 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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
Section 2 addition of wording to increase clarity
Section 4.2 amended wording regarding paediatric use
Section 4.5 minor grammatical change to text
Section 4.8 inclusion of text on experience with paediatric use
Section 4.9 minor grammatical change to text
Section 5.1 inclusion of text on experience with paediatric use
Section 5.2 inclusion of text on experience with paediatric use
Section 6.6 Update in line with current EU guidelines
Updated on 28 November 2005 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 11 November 2005 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 4.1 - Therapeutic indications
- Change to section 5.3 - Preclinical safety data
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 12 August 2005 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)
Updated on 22 September 2004 SPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 17 September 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 23 July 2004 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 1 July 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)