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Brimica Genuair 340 micrograms /12 micrograms inhalation powder

  • Name:

    Brimica Genuair 340 micrograms /12 micrograms inhalation powder

  • Company:
    info
  • Active Ingredients:

    Aclidinium Bromide, Formoterol fumarate dihydrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/10/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 1/10/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

Click on this link to Download PDF directly

A. Menarini Pharmaceuticals Ireland Ltd

A

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Medicine Name Brimica Genuair 340 micrograms /12 micrograms inhalation powder Active Ingredients Aclidinium Bromide, Formoterol fumarate dihydrate
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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 1 October 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to other sources of information section

Free text change information supplied by the pharmaceutical company

Increased prominence to side-effects where you should stop taking the medicne and contact your doctor immeidiately.

Fomatting and administrative changes including the container wording change from 'pouch' to 'bag'

 

 

Updated on 1 October 2019 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 6.3 - Shelf life
  • 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

Fomatting and administrative changes including the container wording change from 'pouch' to 'bag'

Updated on 6 September 2018 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 6 September 2018 SPC

Reasons for updating

  • File format updated to PDF

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

Updated on 27 June 2018

Updated on 26 June 2018 SPC

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

Correction to formatting error

Updated on 10 May 2018 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

The Instructions for Use have been moved from section 4.2 to section 6.6 and updated.

Updated on 4 May 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to improve clarity and readability

Updated on 1 February 2018 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic 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

Update to section 5.2 Pharmacokinetic properties of the SmPC, due to new pharmacokinetic data (addition of effective half-life) from a clinical study and simplification of the ADR footnotes in 4.8 Undesirable effects (without adding or removing ADRs).

Updated on 1 February 2018 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 28 September 2017 SPC

Reasons for updating

  • 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

Update to Section 5.1 Pharmacodynamic properties

 

New information added on lung volumes, exercise endurance and physical activity following an 8-week parallel, randomised, placebo-controlled clinical study in COPD patients with hyperinflation (functional residual capacity [FRC] >120%).

Updated on 21 March 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 March 2017 SPC

Reasons for updating

  • 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

Section 4.8 Undesirable effects:

“Angina pectoris” has been added to the adverse reactions under ‘Cardiac disorders’ with a frequency ‘uncommon’.

Updated on 21 March 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 20 September 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change of distributor details

Updated on 20 September 2016 SPC

Reasons for updating

  • 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



The changes are as follows:

Section 4.8 Undesirable effects

Addition of Anaphylactic reaction (frequency not known) and Stomatitis (uncommon).

Updated on 23 June 2016 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.5 - Nature and contents of container

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$0Addition of a new 30 pack size. $0$0$0$0$0Section 4.2 Posology and method of administration$0$0Minor typographical changes.$0

Updated on 23 June 2016 PIL

Reasons for updating

  • Change to date of revision
  • Introduction of new pack/pack size

Updated on 10 May 2016 SPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

This update is to change the colour of the protective cap and dosage button for the inhaler device from turquoise to orange.

The sections affected are 3, 4.2 and 6.5.

Updated on 10 May 2016 PIL

Reasons for updating

  • Change to further information section
  • Change to appearance of the medicine

Updated on 2 June 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 June 2015 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