Becotide Evohaler 250
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 18 December 2024
File name
ie-pl-becotideevohalerissue10draft1-Master.pdf
Reasons for updating
- Change to Section 1 - what the product is
- 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 1 - Removal of reference to norflurane
Section 6 - Addition of fluorinated greenhouse gases details
Section 6 - Update to leaflet revision date
Updated on 18 December 2024
File name
ie-pl-becotideevohalerissue10draft1-Master.pdf
Reasons for updating
- Change to Section 1 - what the product is
- 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 1 - Removal of reference to norflurane
Section 6 - Addition of fluorinated greenhouse gases details
Section 6 - Update to leaflet revision date
Updated on 07 November 2023
File name
ie-pl-becotideevohalerissue9draft1-working copy-clean-meds.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 21 September 2022
File name
ie-spc-becotide250evohalerissue9draft1-working copy-clean-meds.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 21 September 2022
File name
ie-spc-becotide250evohalerissue9draft1-working copy-clean-meds.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 18 August 2022
File name
ie-spc-becotide250evohalerissue8draft1-MASTER-meds.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 18 August 2022
File name
ie-pl-becotideevohalerissue8draft1-clean-meds.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 10 August 2022
File name
ie-spc-becotide250evohalerissue9draft1-working copy-clean-meds.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 10 August 2022
File name
ie-pl-becotideevohalerissue9draft1-working copy-clean-meds.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 07 December 2021
File name
ie-spc-becotide250evohalerissue8draft1-working copy-clean-meds.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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)
Updated on 08 April 2021
File name
ie-pl-becotideevohalerissue8draft1-clean-meds.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 30 November 2018
File name
ie-pl-becotideevohalerissue7draft3 - Meds ie.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 30 November 2018
File name
ie-spc-becotide250evohalerissue7draft3 - Meds ie.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 4.1: 'Any child' changed to 'Children'
Section 6.4: Addition of the following text:
Do not store above 30oC.
Protect from frost and direct sunlight.
As with most inhaled medications in aerosol canisters, the therapeutic effect of this medication may decrease when the canister is cold.
Updated on 22 December 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 December 2017
Reasons for updating
- 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 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 Section 4.5 - to include interactions section for inhibitors that could potentially interact with Becotide
SPC Section 4.8 - to include undesirable effect for blurred vision
Updated on 21 December 2017
File name
PIL_9780_249.pdf
Reasons for updating
- New PIL for new product
Updated on 21 December 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Improved presentation of PIL
Updated on 09 December 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 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.2: Under the subheading ‘Special patient groups’ revised ‘elderly patients’ to older people’.
Section 4.5: Corrected spelling of metronidazole (previously metronizadole)
Section 4.8 : HPRA AE reporting details updated from IMB to HPRA.
Section 4.8: For consistency with the approved wording for Becotide 50mcg and Becotide 100mcg, under the subheading and ‘Respiratory, thoracic and mediastinal disorders’ added the following statement ‘The use of a large volume 'spacer' device may be considered’, with regards to the adverse reactions ‘hoarseness’ and ‘throat irritation’.
Updated on 08 December 2015
Reasons for updating
- Change to date of revision
- Change to improve clarity and readability
- Addition of information on reporting a side effect.
Updated on 21 July 2015
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to MA holder contact details
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 2015
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 13 November 2014
Reasons for updating
- Correction of spelling/typing errors
- Improved electronic presentation
Updated on 29 July 2014
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 29 August 2013
Reasons for updating
- Change to warnings or special precautions for use
Updated on 25 July 2011
Reasons for updating
- Change due to harmonisation of PIL
- Change due to user-testing of patient information
Updated on 14 February 2007
Reasons for updating
- Change to dosage and administration
Updated on 30 August 2005
Reasons for updating
- Change to side-effects
Updated on 20 May 2005
Reasons for updating
- New PIL for medicines.ie