Login

Pulmicort Turbohaler 200

*
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 19 January 2023

File name

ie-spc-Pulmicort-Turbohaler-200-MAH update-RSP 18 0063.pdf

Reasons for updating

  • Document format updated

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

Updated on 21 November 2019

File name

ie-pl-Pulmicort-Turbohaler-Article 61(3)-RSP 19 0001.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-Turbohaler- 100 200 400-Brexit MAH update-RSP 18 0067.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-Turbohaler-200-Brexit MAH update RSP 18 0063.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 4.4 – 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 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

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_7905_405.pdf

Reasons for updating

  • New PIL for new product

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 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

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 11 November 2014

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - 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 - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 2 editorial changes-aligned to lated QRD template
- Section 4.2 editorial changes-aligned to lated QRD template

- Section 4.3 editorial changes- aligned to lated QRD template

- Section 4.4 editorial changes- aligned to lated QRD template

- Section 4.5 editorial changes- aligned to lated QRD template

- Section 4.6 editorial changes- aligned to lated QRD template

- Section 4.7 editorial changes- aligned to lated QRD template

-Section 4.8 editorial changes- aligned to lated QRD template. Addition of ADR reoporting statement

- section 4.9 editorial changes- aligned to lated QRD template

- Section 5.1 editorial changes- aligned to lated QRD template and CDS update to the wording on growth

-Section 6.6 editorial changes- aligned to lated QRD template

-Section 9 editorial changes- aligned to lated QRD template

-Section 10 date of revision of text updated

Updated on 11 November 2014

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - 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 - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

Free text change information supplied by the pharmaceutical company

- Section 2 editorial changes-aligned to lated QRD template
- Section 4.2 editorial changes-aligned to lated QRD template

- Section 4.3 editorial changes- aligned to lated QRD template

- Section 4.4 editorial changes- aligned to lated QRD template

- Section 4.5 editorial changes- aligned to lated QRD template

- Section 4.6 editorial changes- aligned to lated QRD template

- Section 4.7 editorial changes- aligned to lated QRD template

-Section 4.8 editorial changes- aligned to lated QRD template. Addition of ADR reoporting statement

- section 4.9 editorial changes- aligned to lated QRD template

- Section 5.1 editorial changes- aligned to lated QRD template and CDS update to the wording on growth

-Section 6.6 editorial changes- aligned to lated QRD template

-Section 9 editorial changes- aligned to lated QRD template

-Section 10 date of revision of text updated

Updated on 21 May 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 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 4.2 Posology and method of administration
-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 21 May 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 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

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 4.2 Posology and method of administration
-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 01 February 2012

Reasons for updating

  • Change to separate SPCs covering individual presentations

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

Free text change information supplied by the pharmaceutical company

Section 4.4

 

Paragraph 12 amended to:

 

Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

Section 4.8

 

Rare   

 

“Nervousness, restlessness, depression, behavioural disturbances” replaced with

 

Psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioural changes (predominantly in children).

 

 

Section 10

 

Date of revision changed to 20 January 2012

 

Updated on 01 February 2012

Reasons for updating

  • Change to separate SPCs covering individual presentations

Free text change information supplied by the pharmaceutical company

Section 4.4

 

Paragraph 12 amended to:

 

Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

Section 4.8

 

Rare   

 

“Nervousness, restlessness, depression, behavioural disturbances” replaced with

 

Psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioural changes (predominantly in children).

 

 

Section 10

 

Date of revision changed to 20 January 2012

 

Updated on 11 November 2003

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 4.8 - Undesirable effects
  • Change to section 5 - Pharmacological properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Updated on 11 November 2003

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 4.8 - Undesirable effects
  • Change to section 5 - Pharmacological properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling