Xatral 10mg Prolonged Release Tablets

  • Name:

    Xatral 10mg Prolonged Release Tablets

  • Company:
    info
  • Active Ingredients:

    alfuzosin hydrochloride

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/07/20

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Summary of Product Characteristics last updated on medicines.ie: 4/3/2020

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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 6 July 2020 PIL

Reasons for updating

  • XPIL Removed

Updated on 4 March 2020 SmPC

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 SmPC

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 PIL

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 SmPC

Reasons for updating

  • New SmPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 13 September 2019 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 30 November 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 30 November 2017 SmPC

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

4.4 added:-
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 PIL

Reasons for updating

  • New PIL for new product

Updated on 24 November 2017 PIL

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 SmPC

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

Type IIC.1.3b variation to align the SmPC and product labeling following completion of PSUR Worksharing Procedure for alfuzosin: SE/H/112/01-03/II/55. 

Updated on 10 June 2014 PIL

Reasons for updating

  • Change of contraindications
  • Change to side-effects

Updated on 21 June 2013 SmPC

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 PIL

Reasons for updating

  • Change to side-effects

Updated on 1 February 2013 SmPC

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

Section 4.4 and 4.8 updated with the addition of warnings on use in patients with orthostatic hypotension.

Updated on 31 January 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 5 September 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 14 August 2012 SmPC

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 4.2 has been updated with a new paragraph: Paediatric population
Section 5.1 has been updated with a new paragraph: Paediatric population and the efficacy of alfuzosin hydrochloride

Updated on 30 August 2011 PIL

Reasons for updating

  • Change to side-effects

Updated on 4 April 2011 SmPC

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 1 September 2009 SmPC

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

Change to revision date.

Updated on 10 June 2009 SmPC

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

Correction of typing errors

Updated on 5 June 2009 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 2 October 2008 SmPC

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

Update
Section 9 of SPC Date of last renewal
 

Updated on 24 September 2007 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 24 September 2007 SmPC

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

Section 4.4    Additional class warning for alpha 1 antagonists regarding intraoperative floppy iris syndrome
Section 10    Updated to Sept 2007

Updated on 10 September 2007 SmPC

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

The sections update are:
7    Name and address
8    PA number changed from PA 77/150/3
10    Updated to Aug 2007

Updated on 24 August 2007 SmPC

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 PIL

Reasons for updating

  • New PIL for medicines.ie