Spiriva Respimat 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 - 316414-05 - 21.07.2022 - PIP046410-005 - Cropped.pdf
Reasons for updating
- New PIL for new product
Updated on 23 December 2022
File name
R1e-IE-SPC-15.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- 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 4.1: Update to COPD indication to replace “Tiotropium” with “Spiriva Respimat”.
• Section 4.2: Update to “Method of administration” information.
• Section 4.8: Updated to include minor editorial changes.
• Section 6.3: Updated to include minor editorial changes.
• Section 6.5: Updated to add “Each cartridge contains 4 ml inhalation solution.”.
• 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 11 January 2021
File name
R1e-E-SPC-14 - Approved.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 4.8: Update to the Irish Adverse Events reporting details.
- Section 10: Updated to 18 December 2020.
Updated on 02 December 2019
File name
leaflet 316414-01 AMT 88085 - PIP046410-001 - dated 22.10.18 - CROPPED .pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 3 - how to take/use
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Change to other sources of information section
- Correction of spelling/typing errors
- Change to improve clarity and readability
Updated on 02 December 2019
File name
R1e-E-SPC-13 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 05 October 2018
File name
cropped PIL 309869-14 12Apr2018 PIP005264-014.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 05 October 2018
File name
R1e-E-SPC-11.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 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
The main changes are:
- In section 4.1 Therapeutic indications, the approved asthma indication is now as follows:
Spiriva Respimat is indicated as add-on maintenance bronchodilator treatment in patients aged 6 years and older with severe asthma who experienced one or more severe asthma exacerbations in the preceding year (see sections 4.2 and 5.1).
The COPD indication wording is unchanged.
- Section 4.2 - Posology and method of administration has been revised to include information on for patients 6 to 17 years of age.
The following statement has also been included for adult patients (similar to information previously in the indication section):
In adult patients with severe asthma, tiotropium should be used in addition to inhaled corticosteroids (≥ 800 μg budesonide/day or equivalent) and at least one controller.
- Sections 4.8 – Undesirable effects, 5.1 – Pharmacodynamic properties and 5.2 – Pharmacokinetic properties have been updated with information from the paediatric studies.
Updated on 20 July 2018
File name
cropped Leaflet 309869-14 25.04.2017 PIP005264-014.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- 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 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 16 July 2018
File name
R1e-E-SPC-12 For Med.ie.docx
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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
Sections 4.2, 4.3, 4.6, 4.8, 5.1, 5.2, 9 and 10 of the SPC have been updated. The main changes are revised heading for instructions for use sub-section in 4.2 and re-wording of the existing contraindications (section 4.3). The other section changes are editorial.
Updated on 22 June 2016
File name
PIL_13689_827.pdf
Reasons for updating
- New PIL for new product
Updated on 22 June 2016
Reasons for updating
- Change to improve clarity and readability
Updated on 22 March 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
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 date of revision
- Change to further information section
Updated on 28 January 2015
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- 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 4.2 – the instruction for use pictures have been changed plus some text updates
Main change relates to addition of Tiospir study data (205.452) to 5.1 and PK/PD study 205.458 to 5.2 plus other updates to 4.4, 4.5, 4.8, 4.9. In addition, the pharmaceutical standard term has been updated from solution for inhalation to inhalation solution throughout the SPC – please note that this change impacts the product name. A further change to section 4.2 was also included in the ‘when to get a new Spiriva Respimat inhaler’ text.
Section 10: Revision date has been changed to January 2015
Updated on 22 January 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to further information section
- Change to date of revision
- Change to product name
Updated on 30 September 2014
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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
Updated on 30 September 2014
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to date of revision
- Change to dosage and administration
- Addition of information on reporting a side effect.
Updated on 22 November 2013
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 10 Date of revision has been revised to 10/2013.
Updated on 08 November 2013
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 13 June 2013
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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- 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 10 has been updated to May 2013
Updated on 11 June 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 09 October 2012
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- 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 renewal of 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
For a full list of excipients, see section 6.1.
has been changed to
For the full list of excipients, see section 6.1.
4.2 Posology and method of administration
Editorial changes to text
Revised pictures and text for the “Patients Instructions for use and handling section”
4.6 Fertility, pregnancy and lactation
A section on fertility has been added to this section as well as sub-headings included Fertility; Pregnancy and Breast-feeding.
4.8 Undesirable effects
Change to some of the sub-headings and not known frequency footnote to table of adverse reactions deleted.
4.9 Overdose
The following paragraph has been deleted from this section:
“No significant undesirable effects have been observed in four long term studies in COPD patients with a daily dose of 10 microgram tiotropium solution for inhalation over 4-48 weeks.”
5.1 Pharmacodynamic properties
The pharmacotherapeutic group has been updated; some sub-headings have been added to existing text and the following statement has been added:
“Paediatric population
No data in paediatric population were established (see 4.2).”
5.2 Pharmacokinetic properties
Editorial change
5.3 Preclinical safety data
The following statement has been included in this section:
“In a general reproduction and fertility study in rats, there was no indication of any adverse effect on fertility or mating performance of either treated parents or their offspring at any dosage.”
6.5 Nature and contents of container
Editorial change (one to 1)
6.6 Special precautions for disposal
The word “medicinal” has been added to state:
“Any unused medicinal product or waste material should be disposed of in accordance with local requirements.”
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date has been amended to 24/07/2012
10. DATE OF REVISION OF THE TEXT
Date has been amended to September 2012
Updated on 08 October 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to further information section
- Change to date of revision
- Change in co-marketing arrangement
- Change to dosage and administration
Updated on 02 March 2011
Reasons for updating
- Correction of spelling/typing errors
Updated on 09 September 2010
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Section 4.4 - Special warnings and precautions for use
Addition of paragraph:
‘Spiriva Respimat should be used with caution in patients with known cardiac rhythm disorders (see 5.1).’
Section 4.8 - Undesirable effects
Extensively updated
Section 5.1 - Pharmacodynamic properties
Information on ‘the following health outcome effects were demonstrated in the long term 1-year studies:’ updated - revised section C
Section 10 – Date of revision of the text
Date has been revised to August 2010
Updated on 08 September 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 25 March 2010
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.3 - Shelf life
- 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 SPC has been updated in sections 4.2 - Posology and method of administration, 6.3 -shelf life and 10 - date of revision. The in-use shelf life has been increased from 2 to 3 months (information in sections 4.2 and 6.3) and the overall shelf life has been increased from 2 to 3 years (information in section 6.3).
Section 10 has been revised to September 2009.
Updated on 25 March 2010
Reasons for updating
- Change to storage instructions
- Change to dosage and administration
Updated on 19 September 2008
Reasons for updating
- New PIL for medicines.ie
Updated on 02 May 2008
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)