Last Updated on eMC 20-07-2017 View medicine  | GlaxoSmithKline UK Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:13-07-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

SmPC section 4.8 - Addition of dysphonia as adverse reaction with uncommon frequency

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:21-04-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

SPC Section 4.2
Additional information on Desiccant sachet and rearrangement of text on cleaning the mouthpiece

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:26-01-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 4.8
Addition of AE's:
Vision Blurred as Rare frequency
Intraocular pressure increased as Rare frequency
Paradoxical bronchospasm as Rare frequency

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:22-09-2016

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 4,8 SPC
Addition of Renal AEs
Urinary retention -Rare
Dysuria - Rare
Bladder outlet obstruction -Rare

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:30-03-2016

Legal Category:POM

Black Triangle (CHM): YES

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”.

Reasons for adding or 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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-10-2015

Legal Category:POM

Black Triangle (CHM): YES

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

Reasons for adding or 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

Date of revision of text on the SPC:26-03-2015

Legal Category:POM

Black Triangle (CHM): YES

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
6.4          Special precautions for storage – clarity on shelf life and advising patient to write the discard date on the Ellipta label.

Reasons for adding or updating:

  • New SPC for new product

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): YES