Pulmicort Respules 1mg
*Company:
AstraZeneca Pharmaceuticals (Ireland) DACStatus:
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 30 January 2024
File name
ie-spc-pulmicort-resp-1mg-shelf-life-extension-clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
shelf life updated from 24 to 36 months
Updated on 19 January 2023
File name
ie-spc-Pulmicort-Respules-1mg-Brexit MAH update-RSP 18 0066.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 December 2022
File name
ie-mt-pl-pulmicort-resp-1mg-post-code-upd-RSP 22 0009.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 21 November 2019
File name
ie-pl-Pulmicort-Respules-1 mg-Article 61(3)-RSP 19 0003.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 24 January 2019
File name
20190114-Package Leaflet-ie-Pulmicort-Respules-1 mg-Brexit MAH update-RSP 18 0069.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 23 January 2019
File name
20190114-SPC-ie-Pulmicort-Respules-1mg 2ml-Brexit MAH update-RSP 18 0066.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- 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 7 – Marketing Authorisation Holder details updated
Section 8 – Marketing Authorisation numbers updated
Section 10 – date of revision updated
Updated on 24 July 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 July 2017
Reasons for updating
- 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 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 4.5 – Updated information relating to the risk of increased systemic corticosteroid side effects with CYP3A inhibitors.
Section 4.8 – Addition of ‘vision, blurred’ to ADR table
Section 10 – Date of revision of text
Updated on 20 July 2017
File name
PIL_8000_571.pdf
Reasons for updating
- New PIL for new product
Updated on 20 July 2017
Reasons for updating
- 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 4 - possible side effects
- Change to section 6 - date of revision
Updated on 21 September 2016
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 4.6 - Pregnancy and lactation
- 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 4.2 Editorial changes to reflect the QRD template
Section 4.4 Addition of information relating to pneumonia in patients with COPD
Section 4.6 Updated information relating to pregnancy
Section 4.8 Updated ADR table and statement beneath table. Also updated information relating to adverse effects seen in clinical trials.
Section 10 Updated revision date
Updated on 20 September 2016
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to improve clarity and readability
- Addition of information on reporting a side effect.
Updated on 14 May 2015
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- 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
- Section 1 Editorial changes to reflect latest QRD template
- Section 2 Editorial changes to reflect latest QRD template
-Section 4.2 Editorial changes to reflect latest QRD template
-Section 4.4 Editorial changes to reflect latest QRD template
-Section 4.5 Editorial changes to reflect latest QRD template
-Section 4.6 Editorial changes to reflect latest QRD template
-section 4.7 Editorial changes to reflect latest QRD template
-Section 4.8 Editorial changes to reflect latest QRD template and reporting of adverse reaction statement added
-Section 5.1 Editorial changes to reflect latest QRD template
-Section 6.3 Editorial changes to reflect latest QRD template
-Section 6.6 Editorial changes to reflect latest QRD template. Infomation from 4.2 added.
-Section 9 Editorial changes to reflect latest QRD template
-section 10 revision date updated
Updated on 11 May 2015
Reasons for updating
- Change to date of revision
- Change to improve clarity and readability
- Addition of information on reporting a side effect.
Updated on 22 October 2013
Reasons for updating
- Change to date of revision
- Addition of marketing authorisation holder
Updated on 21 May 2013
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.7 - Effects on ability to drive and use machines
- 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
- Section 4.4 – Update to list of systemic effects
- Section 4.8 – Update to rare side effects
-Section 4.1 Therapeutic indications
-Section 4.2 Posology and method of administration
-Section 4.3 Contraindications -Section 4.4 Special warnings and precautions for use
-Section 4.4 Special warnings and precautions for use
-Section 4.5 Interaction with other medicinal products and other forms of interaction
- Section 4.6 Pregnancy and lactation
-Section 4.7 Effects on ability to drive and use machines
-Section 4.8 Undesirable effects
-Section 4.9 Overdose
- Section 5.1 Pharmacodynamic properties
- Section 5.2 Pharmacokinetic properties
-Section 10 Update to date of revision
Updated on 17 May 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to instructions about overdose
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to date of revision
- Change to dosage and administration
Updated on 02 February 2012
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 30 January 2012
Reasons for updating
- Change to instructions about overdose
- Change to side-effects
- Change to date of revision
Updated on 22 December 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 02 November 2009
Reasons for updating
- Change due to user-testing of patient information
Updated on 17 October 2008
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to dosage and administration
Updated on 03 July 2007
Reasons for updating
- Change to marketing authorisation holder
Updated on 02 March 2005
Reasons for updating
- Change of active ingredient
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to date of revision
Updated on 06 August 2004
Reasons for updating
- New PIL for medicines.ie