Xatral 10mg Prolonged Release Tablets
*Company:
SANOFIStatus:
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 06 November 2024
File name
1.3.1.SmPC Xatral IE (1).pdf
Reasons for updating
- 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 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 06 November 2024
File name
1.3.2.Mock-up Leaflet Xatral.pdf
Reasons for updating
- 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 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
Updated on 23 August 2024
File name
1.3.1.2 IE-PIL Text-10mg Clean -English- IE992 Type IA Deletion of Brexit Sites.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 06 November 2023
File name
1.3.2.1 Mock-up Leaflet Xatral.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 10 January 2022
File name
cropped.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 12 July 2021
File name
Xatral 10mg Patient Leaflet.pdf
Reasons for updating
- XPIL Removed
Updated on 06 July 2020
File name
Xatral 10mg Patient Leaflet.pdf
Reasons for updating
- XPIL Removed
Updated on 04 March 2020
File name
1.3.1.1 IE-SmPC -10mg Clean- English -IE992 Type IA Deletion of Brexit Sites.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 18 October 2019
File name
Xatral 10mg SPC.pdf
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
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 18 October 2019
File name
Xatral 10mg Patient Leaflet.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
Updated on 13 September 2019
File name
SPC Xatral 10mg.pdf
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 13 September 2019
File name
PIL Xatral 10mg.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 30 November 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 30 November 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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
Alfuzosin, like other alpha adrenergic antagonists, has been associated with priapism (persistent painful penile erection unrelated to sexual activity). Because this condition can lead to permanent impotence if not properly treated, patients should be advised about the seriousness of the condition (See Section 4.8 Undesirable Effects).
4.8 added:-
HPRA reporting details.
Updated on 24 November 2017
File name
PIL_12340_287.pdf
Reasons for updating
- New PIL for new product
Updated on 24 November 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 12 June 2014
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 10 June 2014
Reasons for updating
- Change of contraindications
- Change to side-effects
Updated on 21 June 2013
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
Bulk Type II No. C.I.4 variation to update section 4.8 - Undesirable effects of the SmPC for the above mentioned products to comply with the latest Company Core Safety Information (Version 9).
Updated on 19 June 2013
Reasons for updating
- Change to side-effects
Updated on 01 February 2013
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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 31 January 2013
Reasons for updating
- Change to warnings or special precautions for use
Updated on 05 September 2012
Reasons for updating
- Change to warnings or special precautions for use
Updated on 14 August 2012
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- 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
Section 5.1 has been updated with a new paragraph: Paediatric population and the efficacy of alfuzosin hydrochloride
Updated on 30 August 2011
Reasons for updating
- Change to side-effects
Updated on 04 April 2011
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
- 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 - Special warnings and precautions for use:
Care should be taken when alfuzosin is administered to patients who have had a pronounced hypotensive response to another alpha1-blocker. Blood pressure should be monitored regularly, especially at the beginning of treatment.
In patients with coronary insufficiency, specific therapy for coronary insufficiency should be continued. If angina pectoris reappears or worsens alfuzosin should be discontinued.
As with all alpha1-receptor blockers, alfuzosin should be used with caution in patients with acute cardiac failure.
Patients with congenital QTc prolongation, with a known history of acquired QTc prolongation or who are taking drugs known to increase the QTc interval should be evaluated before and during the administration of alfuzosin.
Alfuzosin 10 mg prolonged release tablets contain hydrogenated castor oil which may cause stomach upset and diarrhoea.
As there are no clinical safety data available in patients with severe renal impairment (creatinine clearance < 30ml/min), alfuzosin 10 mg prolonged-release tablets should not be administered to this patient group.
Section 4.8 – Undesirable effects:
Updated to MedRA classification
Section 10 – Date of revision:
Updated to March 2011
Updated on 01 September 2009
Reasons for updating
- 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 10 June 2009
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 05 June 2009
Reasons for updating
- Correction of spelling/typing errors
Updated on 02 October 2008
Reasons for updating
- 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
Updated on 24 September 2007
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 24 September 2007
Reasons for updating
- Change to warnings or special precautions for use
Updated on 10 September 2007
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- 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 24 August 2007
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 August 2007
Reasons for updating
- New PIL for medicines.ie
SANOFI
Address:
Citywest Business Campus, Dublin 24, IrelandMedical Information E-mail:
iemedinfo@sanofi.comTelephone:
+353 1 4035600