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Daxas 500 micrograms film-coated tablets

*
Pharmacy Only: Prescription

  • Company:

    AstraZeneca Pharmaceuticals (Ireland) DAC

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Roflumilast

    *Additional information is available within the SPC or upon request to the company

Updated on 03 October 2024

File name

20240927 SPC IE MT Daxas 500 mcg Remove NI details RSP 24 0009.pdf

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)

Updated on 21 March 2024

File name

20240219 Package Leaflet IE MT Daxas 500mcg Takeda BR removal RSP 24 0007.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 23 November 2023

File name

20231115 SPC IE MT Daxas 500mcg PASS Final Study Report RSP 23 0023.pdf

Reasons for updating

  • Removal of Black Inverted Triangle

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

Updated on 23 November 2023

File name

20231115 Package Leaflet IE MT Daxas 500mcg PASS Final Study Report RSP 23 0021.pdf

Reasons for updating

  • Removal of Black Inverted Triangle

Updated on 19 January 2023

File name

20210920 SPC IE MT NI Daxas 500mcg Postpone PASS Final Study Report RSP 21 0010.pdf

Reasons for updating

  • Document format updated

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

Updated on 08 October 2021

File name

20210920 SPC IE MT NI Daxas 500mcg Postpone PASS Final Study Report RSP 21 0010.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

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

Updated on 08 October 2021

File name

20210920 Package Leaflet IE MT NI Daxas 500mcg Postpone PASS Final Study Report RSP 21 0012.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 24 September 2021

File name

20210920 Package Leaflet IE MT NI Daxas 500mcg Postpone PASS Final Study Report RSP 21 0012.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

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

Updated on 24 September 2021

File name

20210920 Package Leaflet IE MT NI Daxas 250mcg Postpone PASS Final Study Report RSP 21 0011.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 11 September 2020

File name

20200904 SPC IE MT Daxas Tablets 500mcg Addition of Corden as BR site RSP 20 0023.pdf

Reasons for updating

  • 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)

Updated on 11 September 2020

File name

20200904 Package Leaflet IE MT Daxas Tablets 500mcg Addition of Corden as BR site RSP 20 0021.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 04 June 2020

File name

20200520 SPC IE MT Daxas Tablets 500mcg Renewal RSP 20 0014.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - 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)

Updated on 04 June 2020

File name

20200520 Package Leaflet IE MT Daxas Tablets 500mcg Renewal RSP 20 0013.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 24 April 2020

File name

20200424 SPC IE MT Daxas Tablets 500 mg Type IA VAR RSP 20 0007.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 10 - Date of revision of the text

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

Updated on 23 January 2020

File name

20200116-SPC-IE-MT-Daxas-Tablets-500mg-Type II var RSP 19 0010.pdf

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)

Updated on 23 January 2020

File name

20200116-Package Leaflet-IE-MT-Daxas-Tablets-500mg-Type II var RSP 19 0012.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 28 June 2019

File name

20180423-SPC-ie-Daxas-fctablets-500mcg line extension UIM RSP 18 0011.pdf

Reasons for updating

  • File format updated to PDF

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

Updated on 27 May 2018

File name

31792.docx

Reasons for updating

  • New SPC for new product

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

Updated on 04 May 2018

File name

2018-04-23 PIL Daxas 500mcg FCT UK RSP 18 0012.pdf

Reasons for updating

  • Change to section 3 - dose and frequency
  • Change to section 6 - date of revision

Updated on 04 May 2018

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • 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)

Updated on 06 December 2016

Reasons for updating

  • New SPC for new product

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

Updated on 06 December 2016

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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 7: MA holder has been updated with AstraZeneca Ltd details

Section 8: New MA number

Section 10: Date of revision of the text

Updated on 05 December 2016

File name

PIL_14753_883.pdf

Reasons for updating

  • New PIL for new product

Updated on 05 December 2016

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number

Updated on 01 March 2016

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • In section 4.4, information on body weight <60 kg has been added
  • In section 4.8, information on undesirable effects in other special populations and concomitant treatment with long acting muscarinic receptors (LAMA) has been added.
  • In section 5.1, data on clinical efficacy associated with Study RO-2455-404-RD has been added
  • In section 5.2, data on pharmacokinetic properties in special populations has been added.
  • Date of revision has been updated to 17 December 2015

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

Free text change information supplied by the pharmaceutical company

The SmPC has been updated as a result of approval of a Type II variation to update the SmPC with data associated with the REACT study.

  • In section 4.4, information on body weight <60 kg has been added
  • In section 4.8, information on undesirable effects in other special populations and concomitant treatment with long acting muscarinic receptors (LAMA) has been added.
  • In section 5.1, data on clinical efficacy associated with Study RO-2455-404-RD has been added
  • In section 5.2, data on pharmacokinetic properties in special populations has been added.
  • Date of revision has been updated to 17 December 2015

Updated on 12 May 2015

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 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • 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 section

Details of change

4.2. Posology and method of administration

Posology

The recommended dose is one tablet of 500 micrograms (one tablet) roflumilast once daily.

 

Special populations

Older peopleElderly (65 years and older)

4.4.  Special warnings and precautions for use

 

Rescue medicinal products

Roflumilast Daxas is an anti-inflammatory substance indicated for maintenance treatment of severe COPD associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment. It is not indicated as rescue medicinal product for the relief of acute bronchospasms.

 

NOTE: ‘Daxas’ is now referred to as ‘roflumilast’ throughout the rest of the document.

 

4.8. Undesirable Effects

‘Panic attack’ has been added as a ‘Rare’  ‘Psychiatric disorder’.

5.1. Pharmacodynamic properties

Mechanism of action

Roflumilast is a PDE4 inhibitor, a non- steroid, anti- inflammatory agent active substance designed to target both the systemic and pulmonary inflammation associated with COPD.

6.1.  List of excipients

Coating

Hypromellose 2910

10. DATE OF REVISION OF THE TEXT

 

Changed to:

24th April 2015

Updated on 12 May 2015

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 18 September 2013

Reasons for updating

  • Change to side-effects

Updated on 10 September 2013

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 09 September 2013

Reasons for updating

  • Addition of black triangle
  • 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

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

 

In Section 4.8 – Undesirable effects, the following wording has been added:

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to Pharmacovigilance Section, Irish Medicines Board, Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, IRL – Dublin 2. Tel: +353 1 6764971, Fax: +353 1 6767836, Website: www.imb.ie. e-mail:imbpharmacovigilance@imb.ie.

Updated on 16 April 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

Additon of Angioedema to section 4.8

Updated on 16 April 2013

Reasons for updating

  • Change to side-effects

Updated on 20 February 2013

Reasons for updating

  • Change to date of revision

Updated on 02 January 2013

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

Marketing Authorisation Holder has changed to Takeda GmbH
Date of the revision of text has changed to 30/11/2012

Updated on 02 January 2013

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 12 November 2012

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

Addition of warnings regarding Psychiatric effects to sections 4.4 and 4.8 of the SmPC.

Updated on 06 November 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 20 April 2012

Reasons for updating

  • Change to further information section

Updated on 14 July 2011

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

Addition of calendar pack and corresponding changes to pack sizes listed in the SmPC.

Updated on 13 September 2010

Reasons for updating

  • Change to further information section

Updated on 13 August 2010

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 12 August 2010

Reasons for updating

  • New PIL for new product