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Pulmicort Respules 0.5mg

*
Pharmacy Only: Prescription

  • Company:

    AstraZeneca Pharmaceuticals (Ireland) DAC

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

  • Active Ingredient(s):

    Budesonide

    *Additional information is available within the SPC or upon request to the company

Updated on 30 January 2024

File name

ie-spc-pulmicort-resp-0.5 mg-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 extended from 24 to 36 months

Updated on 19 January 2023

File name

ie-spc-Pulmicort-Respules-0.5 mg-MAH update-RSP 18 0065.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-0.5mg-post-code-upd-RSP 22 0008.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 21 November 2019

File name

ie-pl-Pulmicort-Respules-0.5mg-Article 61(3)_RSP 19 0002.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-0.5mg-Brexit MAH update-RSP 18 0068.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-0.5mg2ml Brexit MAH update RSP 18 0065.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 number 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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • 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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 – Updated information relating to the risk of increased systemic corticosteroid side effects with CYP3A inhibitors. Addition of warning on visual disturbance including ‘central serous chorioretinopathy’.
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_7914_740.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 30 July 2015

Reasons for updating

  • Improved electronic presentation

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 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 01 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

None provided

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
  • Change to MA holder contact details

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 05 August 2004

Reasons for updating

  • New PIL for medicines.ie