Becotide Evohaler 250

Product Information *

  • Company:

    GlaxoSmithKline (Ireland) Ltd
  • Status:

    No Recent Update
  • Active Ingredients * :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

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 08 April 2021

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 30 November 2018

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

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 4.4 - to include warning regarding blurred vision
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

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 21 December 2017

Reasons for updating

  • New PIL for new product

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

Update to MA holder contact details - Address change

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

None provided

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