We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we'll assume that you are happy to receive all cookies on the medicines.ie website. Find out more

Novartis Ireland Limited

Vista Building, Elm Park Business Park, Merrion Road, Dublin 4, Ireland
Telephone: +353 1 2601255
Fax: +353 1 2601263
Medical Information e-mail: medinfo.dublin@novartis.com
Summary of Product Characteristics last updated on medicines.ie: 13/10/2017
SPC Onbrez Breezhaler 150 microgram inhalation powder, hard capsules

When a pharmaceutical company changes an SPC or PIL, 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 13/10/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
Date of revision of text on the SPC:   26-Sep-2017
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 13/06/2017 and displayed until 13/10/2017
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   23-Feb-2017
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 22/10/2014 and displayed until 13/06/2017
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   13-Oct-2014
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 06/10/2014 and displayed until 22/10/2014
Reasons for adding or 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
Date of revision of text on the SPC:   18-Sep-2014
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 05/01/2014 and displayed until 06/10/2014
Reasons for adding or 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
Date of revision of text on the SPC:   16-Dec-2013
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 19/09/2013 and displayed until 05/01/2014
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   26-Aug-2013
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 23/12/2010 and displayed until 19/09/2013
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic properties
  • Individual presentations superseded by joint SPC
Date of revision of text on the SPC:   16-Dec-2010
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 01/07/2010 and displayed until 23/12/2010
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   16-Jun-2010
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 01/03/2010 and displayed until 01/07/2010
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

None provided

Document Links

 
  View all medicines
from this company
View Document
Bookmark and Share

Active Ingredients

 
   Indacaterol maleate