Seebri Breezhaler 44 micrograms inhalation powder, hard capsules
*Company:
Novartis Ireland LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 11 November 2021
File name
Seebri Breezhaler_REG PIL_PF21-0293_October 2021_Clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to other sources of information section
- Change to MA holder contact details
Updated on 11 November 2021
File name
Seebri Breezhaler_REG SPC_PF21-0293_October 2021_IPHA.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Other
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 05 May 2021
File name
Seebri Breezhaler_REG PIL_PF21-0104_April 2021_Clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 07 February 2020
File name
Seebri Breezhaler REG PIL PF 20-0022 January 2020 IPHA.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 19 December 2019
File name
Seebri REG PIL PF 19-0279 December 2019 Clean.pdf
Reasons for updating
- Change to other sources of information section
Updated on 19 December 2019
File name
Seebri REG SPC PF 19-0279 December 2019_IPHA.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- 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 08 April 2019
File name
Seebri_REG_SmPC_PF18-0153_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
Seebri Breezhaler REG PIL_1131944_A18_R91_p3_BKLT_X-4_RA Approved 26.10.2018_TBI 09.02.2019_IPHA.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 22 January 2019
File name
PIL_15575_523.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 13 July 2018
File name
Seebri_REG_SmPC_PF18-0153_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 22 May 2018
File name
Seebri_REG_SmPC_PF18-108_clean.docx
Reasons for updating
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 09 May 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 17 October 2017
File name
PIL_15575_523.pdf
Reasons for updating
- New PIL for new product
Updated on 17 October 2017
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - excipient warnings
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
Updated on 04 August 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 04 August 2017
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- 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 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
- Change to section 9 - Date of first authorisation/renewal of the 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
Section 3 Pharmaceutical Form - Added "(inhalation powder)"
Section 4.2 Posology and method of administration:
Added the tracked text “Seebri Breezhaler should be used only if the expected benefit outweighs the
potential risk since the systemic exposure to glycopyrronium may be increased in this population” under
the Renal impairment section in order to provide more detailed information to the prescriber.
Added “No dose adjustment is required in patients with hepatic impairment.” under the Hepatic impairment section.
Added “The capsules must only be removed from the blister immediately before use.” under the Method of Administration section.
Section 4.4 Special warnings and precautions for use – changed “Seebri Breezhaler” to “treatment” where applicable.
Section 4.5 Interaction with other medicinal products and other forms of interaction – changed “Seebri Breezhaler” to “glycopyrronium” where applicable.
Section 4.8 Undesirable effects - Introduced ‘Nausea’, ‘Vomiting’ and ‘Musculoskeletal pain’ as Post Marketing ADRs
Section 5.1 Pharmacodynamic properties – changed “Seebri Breezhaler” to “glycopyrronium” where applicable.
Section 6.4 Special precautions for storage – Added the tracked text as follows: “The capsules must always be stored in the original blister in order to protect from moisture. The capsules must and only be removed immediately before use.”
Section 6.5 Nature and contents of container – changed “blister” to “blister strip”
Section 6.6 Clarified some of the instruction for use
Section 9 Inserted “Date of latest renewal”
Updated on 16 November 2016
Reasons for updating
- Change to section 4 - possible side effects
Updated on 28 October 2016
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 27 October 2015
Reasons for updating
- Change to side-effects
- Change to drug interactions
Updated on 06 October 2015
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
"Although no formal drug interaction studies have been performed, Seebri Breezhaler has been used concomitantly with other medicinal products commonly used in the treatment of COPD without clinical evidence of drug interactions. These include sympathomimetic bronchodilators, methylxanthines, and oral and inhaled steroids."
Section 4.8 - added "paradoxical brochospasm" as side effect with "not known" frequency, also added "pruritis" as side effect with "uncommon" frequency
Updated on 17 July 2015
Reasons for updating
- Change to marketing authorisation holder
- Introduction of new pack/pack size
Updated on 28 May 2015
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- 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
Section 6.5 Nature and contents of container - added details on new 10-pack blister
Section 7 - updated MAH details
Updated on 09 September 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 03 July 2014
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
"Patients who do not experience improvement in breathing should be asked if they are swallowing the medicine rather than inhaling it."
section 4.4- added
"Hypersensitivity
Immediate hypersensitivity reactions have been reported after administration of Seebri Breezhaler. If signs suggesting allergic reactions occur, in particular, angioedema (including difficulties in breathing or swallowing, swelling of the tongue, lips, and face), urticaria or skin rash, Seebri Breezhaler should be discontinued immediately and alternative therapy instituted."
section 4.8 - added
|
Immune system disorders |
|
|
Hypersensitivity |
Uncommon |
|
Angioedema2) |
Uncommon |
2) Reports have been received from post-approval marketing experience in association with the use of Seebri Breezhaler. These were reported voluntarily from a population of uncertain size, and it is therefore not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure. Therefore the frequency was calculated from clinical trial experience.
And also updated the IMB contact details to reflect their new name, i.e HPRA
Updated on 06 March 2014
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
Added:
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:
IMB Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie
and also made minor correction to % of dry mouth.
Section 5.1:
Added:
COPD exacerbation data was collected in the 6- and 12–month pivotal studies. In both studies, the percentage of patients experiencing a moderate or severe exacerbation (defined as requiring treatment with systemic corticosteroids and/or antibiotics or hospitalisation) was reduced. In the 6-month study, the percentage of patients experiencing a moderate or severe exacerbation was 17.5% for Seebri Breezhaler and 24.2% for placebo (Hazard ratio: 0.69, p=0.023), and in the 12-month study it was 32.8% for Seebri Breezhaler and 40.2% for placebo (Hazard ratio: 0.66, p=0.001).
Updated on 28 February 2014
Reasons for updating
- Addition of information on reporting a side effect.
- Addition of black triangle
Updated on 06 December 2012
Reasons for updating
- New PIL for new product
Updated on 05 December 2012
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)