Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed *
Pharmacy Only: Prescription

  • Company:

    GlaxoSmithKline (Ireland) Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

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

Updated on 19 August 2021

File name

ieukni-pil-combined- incruse-issue15draft1_1629391562.pdf

Reasons for updating

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

Updated on 26 February 2021

File name

ie-pil-incruse-issue14draft1-medie_1614341926.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 16 December 2020

File name

ie-pil-incruse-issue13draft1_1608137429.pdf

Reasons for updating

  • Change to MA holder contact details

Updated on 31 July 2020

File name

ie-pil-incruse-issue12draft1-medie_1596207348.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 02 October 2019

File name

ie-spc-incruse-issue12draft1-medicines.ie_1570012511.pdf

Reasons for updating

  • 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 02 October 2019

File name

ie-pil-incruse-issue12draft1-medicines.ie_1570012478.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 24 January 2019

File name

ie-pil-incruse-issue11draft1 - Meds ie_1548341226.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • 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 2 - driving and using machines
  • Change to section 3 - how to take/use
  • 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
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 24 January 2019

File name

ie-spc-incruse-issue11draft1 - Meds ie_1548341323.pdf

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 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 28 November 2018

File name

ie-pil-incruse-issue10draft1 for Meds.ie_1543413785.pdf

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 28 November 2018

File name

ie-spc-incruse-issue10draft1 for Meds.ie_1543413705.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

Section 4.8: Splitting of pack to include just specific IE reporting details due to Brexit preparations
Section 7: Change of MAH address
 

Updated on 01 November 2018

File name

uk-ie-pil-incruse-issue9draft1-Med.ie_1541067003.pdf

Reasons for updating

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

Updated on 18 July 2018

File name

ie-pil-incruse.pdf

Reasons for updating

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

Updated on 18 July 2018

File name

ie-spc-incruse-medsie.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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)

Free text change information supplied by the pharmaceutical company

Section 1 - name of medicinal product - changed from Incruse to Incruse Ellipta.

Section 4.8 - addition of reporting details.

Trade name amended from Incruse to Incruse Ellipta throughout.

 

Updated on 20 July 2017

File name

PIL_16021_648.pdf

Reasons for updating

  • New PIL for new product

Updated on 20 July 2017

Reasons for updating

  • New SPC for new product

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

Updated on 20 July 2017

Reasons for updating

  • 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

SmPC section 4.8 - Addition of eye pain as adverse reaction with rare frequency
SmPC section 4.8 - Addition of intraocular pressure increased as adverse reaction with not known frequency

Updated on 20 July 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 04 May 2017

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 4.8- addition of Allergic reactions

section 4.2 – clarification on desiccant sachet should not be opened &  administrative changes

Updated on 03 May 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 17 January 2017

Reasons for updating

  • 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 4.8 – addition of adverse events:

Eye Disorder –   Glaucoma – not known

                                Vision blurred    not known

 

Renal and Urinary disorders        Urinary retention             unknown

                                                                Dysuria                                 unknown

Updated on 16 January 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 23 November 2015

Reasons for updating

  • 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

Update section 4.8 of the SPC to add dysgeusia as a new adverse event with the frequency ‘uncommon’.

Updated on 20 November 2015

Reasons for updating

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

Updated on 06 October 2015

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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: Clarification regarding “Discard by date”

 

Section 6.3: Clarification of in-use stability

 

Section 6.4: Clarification regarding “Discard by date”

Updated on 06 October 2015

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 06 May 2015

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Section 5.1 – Inclusion of results of supporting efficacy studies

Updated on 23 December 2014

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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)

Free text change information supplied by the pharmaceutical company

Section 4.8 – Add the terms “dry mouth” and “constipation” (recognised LAMA class effects) as adverse events. Update to Irish reporting details to state ‘HPRA’.

Updated on 22 December 2014

Reasons for updating

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

Updated on 09 June 2014

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 06 June 2014

Reasons for updating

  • New PIL for new product