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Meda Health Sales

Unit 34/35, Block A, Dunboyne Business Park, Dunboyne, Co. Meath, Dublin, Ireland
Telephone: 00 353 18026624
Fax: 00 353 18026629
Medical Information Direct Line: 00 353 1 802 6627
Medical Information e-mail: medinfo@meda.ie
Medical Information Facsimile: 00 353 1 802 6629
Summary of Product Characteristics last updated on medicines.ie: 19/06/2017
SPC Novolizer Budesonide 400 micrograms inhalation powder

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 19/06/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   12-Jun-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



In section 4.4: Information regarding visual disturbance has been added.

In section 4.8: Blurred vision has been added to undesirable effects with frequency of not known

In section 10: The date of revision has been changed.

Updated on 11/04/2017 and displayed until 19/06/2017
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07-Apr-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



In section 4.5: Information regarding interaction with cobicistat-containing products has been added

In section 10: The date of revision has been changed.

Updated on 19/08/2016 and displayed until 11/04/2017
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   16-Aug-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



In section 2: Minor text addition.

In section 4.6: Information added regarding pregnancy.

In section 4.8: Changes in frequency of some side effects. Side effects added.

In section 10: Date of revision changed
Updated on 14/10/2013 and displayed until 19/08/2016
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   10-Oct-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



In section 4.2: change of text to refer to the elderly as ‘older people’

In section 4.8: Information on how to report adverse reactions and contact details of the IMB have been added

In section 10: The date of revision has been changed.

Updated on 26/06/2013 and displayed until 14/10/2013
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   17-Jun-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



In section 4.5: the following text has been added; These patients may exhibit signs and symptoms of adrenal insufficiency when exposed to severe stress.

In section 4.6: the title has been changed to reflect the relevant SmPC structure

In section 4.8; small text changes has been made to the adverse table and reference to difficulty in swallowing has been replaced by throat irritation

In section 4.9: Additional information has been added

In section 10: the date of revision has changed

Updated on 14/01/2013 and displayed until 26/06/2013
Reasons for adding or 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   21-Dec-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



·         In section 4.4; additional warnings and precautions for use have been added

·         In section 4.5: additional information has been added regarding interaction with other medicinal products. In this section some text has also been removed

·         In section 4.6: information has been expanded in relation to the use of budesonide in pregnancy and in breastfeeding

·         In section 4.7: information has changed to show that budesonide has no effect on the ability to drive and operate machinery

·         In section 4.8: the side effects table has been replaced and additional information has been added to this section. Information regarding the paediatric  population has been added

·         In section 4.9: the information regarding overdose has changed and the text in this section has been replaced with a single sentence which states that budesonide overdose is not expected to be a clinical problem

·         In section 6.5: information that the product has been packed in a polypropylene container sealed by aluminium foil is added. Additional refill pack information has been added also to this section

·         In section 10: the date of revision has changed

Updated on 27/10/2011 and displayed until 14/01/2013
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Oct-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

In section 2; the following statement is added - For a full list of excipients, see section 6.1
In section 4.4; additional warnings have been added
In section 4.8; an additional column 'Not Known; has been added to the table
In section 7; the MA address has changes
In section 10; the date of revision has changed
Updated on 20/04/2011 and displayed until 27/10/2011
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Apr-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

In section 9; the date of renewal has been changed to 1 June 2008
In section 10; the date of revision has changed to April 2011
Updated on 18/04/2011 and displayed until 20/04/2011
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   01-Oct-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

in all sections the name Novopulmon Novolizer has been changed to the correct name in IE - Novolizer Budesonide
Updated on 20/01/2011 and displayed until 18/04/2011
Reasons for adding or updating:
  • New SPC for medicines.ie
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Budesonide