Seebri Breezhaler 44 micrograms inhalation powder, hard capsules *
Pharmacy Only: Prescription

  • Company:

    Novartis Ireland Limited
  • Status:

    No Recent Update
  • Legal 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_1636632600.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_1636632533.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_1620213450.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_1581071383.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_1576766984.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_1576766895.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_1554717480.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_1552563312.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

Section 4.8 - dysphonia was added as uncommon ADR

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

Section 4.5 - added:
"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

section 4.2 - Added
"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

Section 4.8:

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)

Free text change information supplied by the pharmaceutical company

None provided