Novolizer Budesonide 200 micrograms inhalation powder
- Name:
Novolizer Budesonide 200 micrograms inhalation powder
- Company:
Mylan IRE Healthcare Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 19/06/18
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Mylan IRE Healthcare Limited
Company Products
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 14 June 2019 SPC
Reasons for updating
- Change to improve clarity and readability
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 19 June 2018 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 19 June 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 26 January 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 26 January 2018 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 26 January 2018 PIL
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated on 19 June 2017 SPC
Reasons for 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
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 19 June 2017 PIL
Reasons for 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
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 April 2017 SPC
Reasons for 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
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 11 April 2017 PIL
Reasons for 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
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 August 2016 PIL
Reasons for 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
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 changedUpdated on 19 August 2016 SPC
Reasons for 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
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 changedUpdated on 14 October 2013 PIL
Reasons for 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
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 14 October 2013 SPC
Reasons for 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
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 June 2013 PIL
Reasons for 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
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 26 June 2013 SPC
Reasons for 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
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 January 2013 SPC
Reasons for 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
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 14 January 2013 PIL
Reasons for 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
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 26 October 2011 PIL
Reasons for 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
Free text change information supplied by the pharmaceutical company
In section 4.4 the following text is added; and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
In section 4.8; changes have been made to the table; another column has been added for 'Not known'
In section 7; the MA address has changed
In section 10; the date of revision has changed
Updated on 26 October 2011 SPC
Reasons for 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
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 the following text is added; and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
In section 4.8; changes have been made to the table; another column has been added for 'Not known'
In section 7; the MA address has changed
In section 10; the date of revision has changed
Updated on 19 April 2011 SPC
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 10; the date of revision has changed to April 2011
Updated on 19 April 2011 SPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 19 April 2011 PIL
Reasons for updating
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Updated on 19 April 2011 PIL
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 10; the date of revision has changed to April 2011
Updated on 20 January 2011 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 20 January 2011 PIL
Reasons for updating
- New SPC for medicines.ie