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Spiolto Respimat 2.5 microgram/2.5 microgram, inhalation solution

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Pharmacy Only: Prescription

Updated on 12 December 2024

File name

PIL (Ing) 316415-06 dated 31.07.2024 PIP046419-006 - Cropped.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Free text change information supplied by the pharmaceutical company

Information on the usage period of the Respimat re-usable device included.

Updated on 10 December 2024

File name

R1g-IE-SPC-9.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: To include information on the usage period of the Respimat re-usable device
  • Section 10: Section 10: Updated to 03/12/2024.


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

The update to section 4.8 (Undesirable effects) was to revise the frequencies for two side effects (dysphonia changed from rare to uncommon; urinary tract infection changed from not known to rare).  The number of patients/trials included in section 4.8 has also been updated along with some re-ordering of side effects according to frequency and seriousness.  The update to section 5.1 (Pharmacodynamic properties) of the SPC was to include SGRQ data.  The heading of section 4.1 and the date of revision have also been updated to align with the HPRA approval documents. Black triangle with additional explanatory statement has also been added to the SPC.

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

None provided

Updated on 02 July 2015

Reasons for updating

  • New PIL for new product