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AstraZeneca UK Limited
Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU
Telephone: +44 (0)1582 836 000
Fax: +44 (0)1582 838 000
Medical Information Direct Line: +44 (0)1582 836 836
Medical Information e-mail: medical.informationuk@astrazeneca.com
Customer Care direct line: +44 (0)1582 837 837
Medical Information Fax: +44 (0)1582 838 003

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 04/09/2009
SPC Pulmicort Turbohaler 200

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 04/09/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   13-Aug-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.3 Contraindications

New text,

“Hypersensitivity to budesonide”

 

Section 4.4 Special warnings and special precautions for use

New text to first paragraph,

“Special caution is necessary in patients with active or quiescent pulmonary tuberculosis, and in patients with fungal or viral infections in the airways.”

 

Section 10 Date of revision of the text

“13th August 2009”
Updated on 31/07/2009 and displayed until 04/09/2009
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   21-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.6

Deletion of text at end of paragraph:
There is no information regarding the passage of budesonide into breast milk.

Addition of paragraph at end of section:
Budesonide is excreted in breast milk. However, at therapeutic doses of Pulmicort Turbohaler no effects on the suckling child are anticipated. Pulmicort Turbohaler can be used during breast feeding.

Section 10

Change of date to:
21st July 2009
Updated on 21/05/2009 and displayed until 31/07/2009
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   06-May-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8
Addition of rare side effect to adverse events table:

Anaphylactic reaction

Section 10
Change of date to:

6th May 2009
Updated on 09/07/2008 and displayed until 21/05/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   12-May-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.2

Change of text from

Children 12 years of age and under

to

Children 5 - 12 years of age

 

Section 10

Date of revision of text: 12 May 2008
Updated on 13/04/2005 and displayed until 09/07/2008
Reasons for adding or 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 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
Updated on 20/07/2004 and displayed until 13/04/2005
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
Updated on 19/12/2003 and displayed until 20/07/2004
Reasons for adding or 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 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Updated on 19/08/2002 and displayed until 19/12/2003
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 17/04/2002 and displayed until 19/08/2002
Reasons for adding or updating:
  • New SPC for new product
Updated on 24/08/2001 and displayed until 17/04/2002
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  budesonide