Seebri Breezhaler 44 micrograms inhalation powder, hard capsules

  • Name:

    Seebri Breezhaler 44 micrograms inhalation powder, hard capsules

  • Company:
    info
  • Active Ingredients:

    Glycopyrronium bromide

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 07/02/20

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Summary of Product Characteristics last updated on medicines.ie: 19/12/2019

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Novartis Ireland Limited

Novartis Ireland Limited

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1 - 0 of 118 items.Total: Infinity pages

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 7 February 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 19 December 2019 PIL

Reasons for updating

  • Change to other sources of information section

Updated on 19 December 2019

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling

Updated on 8 April 2019

Reasons for updating

  • File format updated to PDF

Updated on 14 March 2019 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 22 January 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 13 July 2018

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

Reasons for updating

  • Removal of Black Inverted Triangle

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 9 May 2018

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 17 October 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 17 October 2017 PIL

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 4 August 2017 SPC

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 4 August 2017

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 16 November 2016 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 28 October 2016 SPC

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 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions

Updated on 6 October 2015 SPC

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 PIL

Reasons for updating

  • Change to marketing authorisation holder
  • Introduction of new pack/pack size

Updated on 28 May 2015 SPC

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 9 September 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 3 July 2014 SPC

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 6 March 2014 SPC

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 PIL

Reasons for updating

  • Addition of information on reporting a side effect.
  • Addition of black triangle

Updated on 6 December 2012 PIL

Reasons for updating

  • New PIL for new product

Updated on 5 December 2012 SPC

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