ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
No Recent UpdateLegal 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 17 November 2023
File name
ieukni-pil-combined-anoro-issue19draft1-Master.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 4 updated to delete the duplicated listing of the adverse drug reaction 'rash'.
Section 2 updated to add the warning to notify your doctor before using ANORO ELLIPTA if you have low potassium in your blood.
Section 6 updated to improve the description of the pack and its contents.
Section 6 updated the date of last revision to 11/.2023
Sections 2, 3, 4, 5 and 6 updated editorial details to align with related products and with the QRD template 10.3.
Updated on 17 November 2023
File name
ieukni-spc-combined-anoro-issue13draft1-Master.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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.5 - Nature and contents of container
- 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 to remove the duplication of 'rash' from the list of adverse drug reactions (ADRs) with frequency uncommon.
Sections 2, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2 and 6.5 to align the wordingh with the SPC of related products and with QRD version 10.3.
Updated on 15 December 2022
File name
ieukni-pil-combined-anoro-issue18draft1-Master.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Package Leaflet Updates
4 Possible side effects
Added the subheading ‘Other side effects’
Under ‘Uncommon’, added muscle spasms
Under ‘Rare’, removed reference to high pressure regarding eye pain.
Made minor editorial changes.
6 Contents of the pack and other information
Changed the date of revision of the leaflet to 11/2022
Updated on 15 December 2022
File name
ieukni-spc-combined-anoro-issue12draft1-Master.pdf
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
SPC updates:
4.8 Undesirable effects
Added the Adverse Reaction ‘Eye pain’ with the frequency ‘Rare’
Added the Adverse Event ‘Muscle spasms’ with the frequency ‘Uncommon’
Updated the AE reporting to add the UK-Northern Ireland reporting details and to change the layout of the Irish AE reporting details.
10. DATE OF REVISION OF THE TEXT
Updated to 18 November 2022
Updated on 28 July 2021
File name
ie&ukni-pil-anoro-issue1draft1.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 23 February 2021
File name
ie-pil-anoro-issue16draft1-medie.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 16 December 2020
File name
ie-pil-anoro-issue15draft1.pdf
Reasons for updating
- Change to MA holder contact details
Updated on 16 December 2020
File name
ie-pil-anoro-issue15draft1.pdf
Reasons for updating
- Change to MA holder contact details
Updated on 04 October 2019
File name
ie-spc-anoro-issue11draft1-medicines.ie.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-spc-anoro-issue11draft1-medicines.ie.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-anoro-issue14draft1-medicines.ie.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 29 January 2019
File name
ie-pil-anoro-issue13draft1 - Meds ie.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 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
- 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 29 January 2019
File name
ie-spc-anoro-issue10draft1 - Meds ie.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 17 December 2018
File name
ie-pil-anoro-issue12draft1 - Meds ie.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 - manufacturer
- Change to section 6 - date of revision
Updated on 17 December 2018
File name
ie-spc-anoro-issue9draft1 - Meds ie.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)
Updated on 20 August 2018
File name
ie-pil-anoro.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to name of medicinal product
Updated on 20 August 2018
File name
ie-spc-anoro.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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
Addition of Ellipta to the Tradename throughout sections of the SPC
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
File name
PIL_16004_78.pdf
Reasons for updating
- New PIL for new product
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
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 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
Additional information on Desiccant sachet and rearrangement of text on cleaning the mouthpiece
Updated on 03 May 2017
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 03 February 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
Addition of AE's:
Vision Blurred as Rare frequency
Intraocular pressure increased as Rare frequency
Paradoxical bronchospasm as Rare frequency
Updated on 31 January 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 24 October 2016
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
Addition of Renal AEs
Urinary retention -Rare
Dysuria - Rare
Bladder outlet obstruction -Rare
Updated on 21 October 2016
Reasons for updating
- Change to side-effects
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 04 August 2016
Reasons for updating
- Previous version of PIL reinstated
Updated on 03 August 2016
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 08 April 2016
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 to include Glaucoma as an adverse event with the frequency “not known”.
Updated on 07 April 2016
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 29 January 2016
Reasons for updating
- Change to date of revision
- Addition of manufacturer
Updated on 24 December 2015
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 08 October 2015
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 9 - Date of renewal of authorisation
- 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 - Paediatric population: minor administrative change
Section 4.5 - Metabolic and transporter based interactions: Minor correction
Section 4.8 - Addition of new adverse reactions: Hypersensitivity reactions including: Rash (uncommon), Anaphylaxis, angioedema, and urticaria (rare), Tremor (uncommon), Dysgeusia (uncommon), Palpitations (uncommon)
Section 5.1 - Amendment to section regarding clinical information on the use of rescue medication
Section 9 - Addition of the date of grant of the marketing authorisation
Updated on 08 October 2015
Reasons for updating
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 09 April 2015
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
Description of change to SPC:
4.2 Posology and method of administration – additional information to advise the patient to not open the tray until they are ready to
inhale a dose and for the patient to write the discard date on the Ellipta label.
4.8 Undesirable effects – update HPRA AE reporting details
6.3 Shelf life - clarity on shelf life
Updated on 08 April 2015
Reasons for updating
- Change to storage instructions
- Change to date of revision
- Addition of information on reporting a side effect.
- Correction of spelling/typing errors
Updated on 16 May 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
Updated on 15 May 2014
Reasons for updating
- New PIL for new product