ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed
- Name:
ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed
- Company:
GlaxoSmithKline (Ireland) Ltd
- 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: 02/10/19
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GlaxoSmithKline (Ireland) Ltd
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Company Products
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 4 October 2019 SmPC
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 2 October 2019 SmPC
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 2 October 2019 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 29 January 2019 PIL
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 SmPC
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 PIL
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 SmPC
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 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to name of medicinal product
Updated on 20 August 2018 SmPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 20 July 2017 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 20 July 2017 SmPC
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 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 4 May 2017 SmPC
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 3 May 2017 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 3 February 2017 SmPC
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 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 24 October 2016 SmPC
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 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 4 August 2016 PIL
Reasons for updating
- Previous version of PIL reinstated
Updated on 3 August 2016 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 8 April 2016 SmPC
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 7 April 2016 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 29 January 2016 PIL
Reasons for updating
- Change to date of revision
- Addition of manufacturer
Updated on 24 December 2015 PIL
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 8 October 2015 SmPC
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 8 October 2015 PIL
Reasons for updating
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 9 April 2015 SmPC
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 8 April 2015 PIL
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 SmPC
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 PIL
Reasons for updating
- New PIL for new product