Spiolto Respimat 2.5 microgram/2.5 microgram, inhalation solution
*Company:
Boehringer Ingelheim 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 23 December 2022
File name
PIL 316415-05 28.07.2022 PIP046419-005 - Cropped.pdf
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 2 - interactions with other medicines, food or drink
- 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 - marketing authorisation holder
Updated on 23 December 2022
File name
R1g-IE-SPC-8.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.3 - Shelf life
- 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)
Free text change information supplied by the pharmaceutical company
• Section 4.2: Update to “Method of administration” information.
• Section 6.3: Updated to include minor editorial changes.
• Section 7: Updated to remove “-D” from Marketing Authorisation Holder address.
• Section 10: The date of revision has been updated to December 2022 to align with the approval date 15/12/2022.
Updated on 12 January 2021
File name
PIL - 316415-03 - 26.07.20 - PIP046419-003 AMT101144 - PD & SK Reviewed OK - REDUCED - CROPPED.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 11 January 2021
File name
R1g-E-SPC-7 .pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 4.2: The sentence “Respimat is an inhaler device that generates a spray for inhalation.” has been included in the SmPC under the section ‘Instruction for use’ to provide the user/patient a clear information of the purpose of the device (Respimat).
- Section 10: Updated to 18 December 2020.
Updated on 27 May 2020
File name
Leaflet (Ing) - 316415-02 - 12.02.2020 - PIP046419-002 - AMT 98483 - CROPPED.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to other sources of information section
- Removal of Black Inverted Triangle
Updated on 27 May 2020
File name
R1g-E-SPC-6 medicines.ie.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Renewal (NL/H/3157/001/R/001)
- Removal of the inverted black triangle and the additional monitoring text.
- Section 4.8: AE reporting details;
- Section 9: inclusion of the date of renewal
- Section 10: updated date of revision
Updated on 02 December 2019
File name
Cropped Leaflet - AMT 88084 - 316415-01 - 18.04.2019 - PIP046419-001.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
Updated on 02 December 2019
File name
Cropped Leaflet - AMT 88084 - 316415-01 - 18.04.2019 - PIP046419-001.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product looks like and pack contents
Updated on 02 December 2019
File name
R1g-E-SPC-4 for medicines.ie.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- 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
Sections 2 and 4.4: Inclusion of information on the excipient benzalkonium chloride
Section 4.2 – Posology and method of administration: to include the instructions for use for the re-usable device
Section 6.3 – Shelf life: to include an in-use shelf life for the inhaler and recommended use: 6 cartridges per inhaler
Section 6.5 – Nature and contents of container: to include the new pack sizes
Section 10 – Date of revision
Updated on 25 April 2019
File name
PIL 309838-05 - 05.02.2019 - PIP033604-005 AMT 83246 - cropped.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 25 April 2019
File name
R1g-E-SPC-5 approved.pdf
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
- 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 sections 4.8 & 5.1 of the SmPC to incorporate information from the Dynagito study following approval from the HPRA for variation NL/H/xxxx/WS/266 (date of approval 05/04/19 received 16/04/19). The date of revision has been updated to show the HPRA approval date (month/year). The heading of section 4.5 of the SmPC has been updated to align with the HPRA approval documentation.
Updated on 11 May 2017
File name
PIL_16390_336.pdf
Reasons for updating
- New PIL for new product
Updated on 11 May 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Addition of black triangle
Updated on 10 May 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 10 May 2017
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
- Addition of black triangle
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 24 June 2016
Reasons for updating
- Change to improve clarity and readability
Updated on 22 March 2016
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 4.2 updated in respect of the User Instructions.
Section 10: Revision date has been changed to March 2016
Updated on 21 March 2016
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 07 July 2015
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
Updated on 02 July 2015
Reasons for updating
- New PIL for new product