Daxas 500 mcg Film-coated Tablets
- Name:
Daxas 500 mcg Film-coated Tablets
- Company:
AstraZeneca Pharmaceuticals (Ireland) DAC
- 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: 11/09/20

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AstraZeneca Pharmaceuticals (Ireland) DAC
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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 11 September 2020 SPC
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 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 4 June 2020 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 4.4 - 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 4 June 2020 PIL
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 SPC
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 SPC
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 PIL
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 SPC
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 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 4 May 2018 PIL
Reasons for updating
- Change to section 3 - dose and frequency
- Change to section 6 - date of revision
Updated on 4 May 2018 SPC
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 6 December 2016 SPC
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 6 December 2016 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 5 December 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 5 December 2016 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
Updated on 1 March 2016 SPC
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
- 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 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 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
Special populations
|
4.4. Special warnings and precautions for use
|
Rescue medicinal products
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 |
6.1. List of excipients |
Coating Hypromellose |
10. DATE OF REVISION OF THE TEXT
|
Changed to: 24th April 2015 |
Updated on 12 May 2015 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 18 September 2013 PIL
Reasons for updating
- Change to side-effects
Updated on 10 September 2013 PIL
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 9 September 2013 SPC
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 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 16 April 2013 PIL
Reasons for updating
- Change to side-effects
Updated on 20 February 2013 PIL
Reasons for updating
- Change to date of revision
Updated on 2 January 2013 PIL
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 2 January 2013 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
Date of the revision of text has changed to 30/11/2012
Updated on 12 November 2012 SPC
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 6 November 2012 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 20 April 2012 PIL
Reasons for updating
- Change to further information section
Updated on 14 July 2011 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 13 September 2010 PIL
Reasons for updating
- Change to further information section
Updated on 13 August 2010 SPC
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
Updated on 12 August 2010 PIL
Reasons for updating
- New PIL for new product