Onbrez Breezhaler 150 microgram inhalation powder, hard capsules

  • Name:

    Onbrez Breezhaler 150 microgram inhalation powder, hard capsules

  • Company:
    info
  • Active Ingredients:

    Indacaterol maleate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/01/19

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Summary of Product Characteristics last updated on medicines.ie: 17/4/2019

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Novartis Ireland Limited

Novartis Ireland Limited

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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 17 April 2019 SmPC

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 8 April 2019 SmPC

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 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 14 May 2018 SmPC

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 8 May 2018 SmPC

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 SmPC

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 October 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 13 June 2017 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 17 November 2014 PIL

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 SmPC

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 6 October 2014 SmPC

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

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

Updated on 5 January 2014 SmPC

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 SmPC

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 4 January 2013 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 5 October 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects

Updated on 19 September 2012 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 31 May 2012 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 23 December 2010 SmPC

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 1 July 2010 SmPC

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 1 March 2010 SmPC

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 PIL

Reasons for updating

  • New PIL for new product