Brimica Genuair 340 micrograms /12 micrograms inhalation powder
- Name:
Brimica Genuair 340 micrograms /12 micrograms inhalation powder
- Company:
A. Menarini Pharmaceuticals Ireland Ltd
- 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: 01/10/19

XPIL
Package leaflet: Information for the patient
Package leaflet: Information for the patient
1. What Brimica Genuair is and what it is used for
1. What Brimica Genuair is and what it is used for
2. What you need to know before you use Brimica Genuair
2. What you need to know before you use Brimica Genuair
3. How to use Brimica Genuair
3. How to use Brimica Genuair
4. Possible side effects
4. Possible side effects
5. How to store Brimica Genuair
5. How to store Brimica Genuair
6. Contents of the pack and other information
6. Contents of the pack and other information
7. The Genuair inhaler: instructions for use
7. The Genuair inhaler: instructions for use
Click on this link to Download PDF directly
A. Menarini Pharmaceuticals Ireland Ltd

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 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
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)