Incruse Ellipta 55 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 19 December 2023
File name
ieukni-spc-incruse-issue15draft1-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 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- 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 6.5 - 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
4.8: Added the adverse reactions Oropharyngeal pain with frequency of common and Dysphonia with frequency of uncommon.
4.2: Added the statement ‘If a dose is missed the next dose should be inhaled at the usual time the next day.’
4.4: Changed the sub-heading from ‘Lactose contents’ to ‘Excipients’.’
4.6: Updated the statement regarding the use of umeclidinium in pregnant women
6.5: Updated the description of the 7 or 30-dose inhaler and added the clarification that this corresponds to 7 or 30 day supply.
2, 4.2, 4.4, 4.5, 4.6, 4.7, 4.9, 5.1, 5.2, 5.3 Updated with editorial changes and the removal of ‘bromide’ from the name of the active substance.
Updated on 19 December 2023
File name
ieukni-pil-incruse-issue18draft1-Master.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Change to date of revision
Free text change information supplied by the pharmaceutical company
4: Added mouth and throat pain as a common side effect and hoarseness as an uncommon side effect.
2: Added the instruction ‘Do not use this medicine if you are breast-feeding unless your doctor tells you that you can’.
6. Updated the description of the inhaler and pack sizes
Title: Changed ’user’ to ‘patient’.
1, 2, 4, 6: Minor formatting changes.
Instructions for use: Added the statement ‘Do not open the inhaler until you are ready to inhale a dose of medicine.’
Updated on 18 November 2022
File name
ieukni-pil-combined- incruse-issue17draft1-Compendia.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
4 Possible side effects
Deleted the statement ‘Allergic reactions are uncommon (may affect up to 1 in 100 people)’
Added the subheading ‘Uncommon (may affect up to 1 in 100 people)’
Added the following:
Rare (may affect up to 1 in 1000 people)
wheezing, coughing or having difficulty breathing
suddenly feeling weak or light headed (which may lead to collapse or loss of consciousness)
6 Contents of the pack and other information
Changed the date of revision of the leaflet to 11/2022
Updated on 18 November 2022
File name
ieukni-spc-combined-incruse-issue14draft1-Master Compendia.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 ‘Anaphylaxis’ with the frequency ‘Rare’
10. DATE OF REVISION OF THE TEXT
Updated to 09 November 2022
Updated on 02 September 2022
File name
ieukni-spc-combined-incruse-issue13draft1-Master.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
- Correction of spelling/typing errors
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 02 September 2022
File name
ieukni-pil-combined-incruse-issue16draft1-Master.pdf
Reasons for updating
- Correction of spelling/typing errors
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 19 August 2021
File name
ieukni-pil-combined- incruse-issue15draft1.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.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 16 December 2020
File name
ie-pil-incruse-issue13draft1.pdf
Reasons for updating
- Change to MA holder contact details
Updated on 31 July 2020
File name
ie-pil-incruse-issue12draft1-medie.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.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.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.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.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.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.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.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
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_16021_648.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
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 4.2 – 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
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
Updated on 06 June 2014
Reasons for updating
- New PIL for new product