Onbrez Breezhaler 150 microgram inhalation powder, hard capsules
*Company:
Novartis Ireland LimitedStatus:
No Recent UpdateLegal 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 04 November 2024
File name
Onbrez Breezhaler_REG PIL_P24-0134_clean_IPHA.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 16 August 2021
File name
Onbrez Breezhaler_REG PIL_P21-0202_August 2021_clean.pdf
Reasons for updating
- Change to MA holder contact details
Updated on 21 December 2020
File name
Onbrez_REG PIL_PF20-0178_10.12.2020_IPHA.pdf
Reasons for updating
- Change to other sources of information section
Updated on 21 December 2020
File name
Onbrez 150mcg_REG SPC_PF20-0177_10.12.2020_IPHA.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 07 February 2020
File name
Onbrez Breezhaler REG PIL PF 20-0023 January 2020 IPHA.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 18 December 2019
File name
Onbrez REG PIL PF 19-0278 Dec 2019 IPHA.pdf
Reasons for updating
- Change to further information section
Updated on 18 December 2019
File name
Onbrez 150 REG SPC PF 19-0278 December 2019 IPHA.pdf
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 17 April 2019
File name
Onbrez_150 mg_REG SmPC_PF19-0088_IPHA.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 08 April 2019
File name
Onbrez_Breezhaler_150mcg_REG_SmPC_PF18-0064_IPHA.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 January 2019
File name
Onbrez_150_300microgram_PIL_23-Aug-18_clean_IPHA.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 14 May 2018
File name
Onbrez_Breezhaler_150mcg_REG_SmPC_PF18-0064_Clean.docx
Reasons for updating
- 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 08 May 2018
Reasons for updating
- 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 13 October 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 13 October 2017
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 13 June 2017
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 17 November 2014
File name
PIL_14588_608.pdf
Reasons for updating
- New PIL for new product
Updated on 17 November 2014
Reasons for updating
- Change to instructions about overdose
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to improve clarity and readability
- Addition of information on reporting a side effect.
Updated on 22 October 2014
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 06 October 2014
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- 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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 05 January 2014
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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.2
Method of administration
For inhalation use only. Onbrez Breezhaler capsules must not be swallowed.
Onbrez Breezhaler capsules must be administered only using the Onbrez Breezhaler inhaler (see section 6.6).
Patients should be instructed on how to administer the product correctly. Patients who do not experience improvement in breathing should be asked if they are swallowing the medicine rather than inhaling it.
For instructions on use of the medicinal product before administration, see section 6.6
Section 4.5
Beta-adrenergic blockers
Beta-adrenergic blockers and beta2-adrenergic agonists may weaken or antagonise the effect of beta2-adrenergic agonists each other when administered concurrently. Therefore indacaterol should not be given together with beta-adrenergic blockers (including eye drops) unless there are compelling reasons for their use. Where required, cardioselective beta-adrenergic blockers should be preferred, although they should be administered with caution.”
Updated on 19 September 2013
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 04 January 2013
Reasons for updating
- Improved electronic presentation
Updated on 05 October 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
Updated on 19 September 2012
Reasons for updating
- Improved electronic presentation
Updated on 31 May 2012
Reasons for updating
- Change to MA holder contact details
Updated on 23 December 2010
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
- Individual presentations superseded by joint SPC
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 01 July 2010
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
Also corrected the classification of this medicine to "may be renewed" - this was an error with our original uploading of the SPC.
Updated on 01 March 2010
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 24 February 2010
Reasons for updating
- New PIL for new product