Login

Onbrez Breezhaler 300 microgram inhalation powder, hard capsules

*
Pharmacy Only: Prescription

  • Company:

    Novartis Ireland Limited

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Indacaterol Maleate

    *Additional information is available within the SPC or upon request to the company

  • Onbrez Device pack Shot.jpeg

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 300mcg_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 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 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 section 6 - what the product contains

Updated on 18 December 2019

File name

Onbrez 300 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_300 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_300mcg_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 14 March 2019

File name

Onbrez_150_300microgram_PIL_23-Aug-18_clean_IPHA.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 14 May 2018

File name

Onbrez_Breezhaler_300mcg_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

  • 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

  • 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

Section 9 - Correction of the date of latest renewal to 18-Sep-2014 to match the accurate date.

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

Section 6.3 - shelf life was increased from 2 years to 30 months

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

MAH address change from Horsham to Frimley due to Horsham site closure.

Updated on 09 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
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5 - Pharmacological 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

Minor changes to most sections resulting from Renewal application - no safety related changes.

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

Section 4.4: Strengthened warning about Onbrez not being indicated for asthma and also advised caution in patients with known or suspected prolongation of the QT interval

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

In section 5.2 added in "about 75% of systemic exposure was from pulmonary absorption and about 25% from gastrointestinal absorption" under the "Absorption" heading.

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

In section 5.1 add the ATC which was previously unavailable.
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

None provided

Updated on 24 February 2010

Reasons for updating

  • New PIL for new product