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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: 31/07/2009
SPC Pulmicort Respules 0.5mg & 1mg Nebuliser Suspension

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 31/07/2009 and displayed until Current
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 Respules no effects on the suckling child are anticipated. Pulmicort Respules can be used during breast feeding.

Section 10

Change of date to:
21st July 2009
Updated on 20/05/2009 and displayed until 31/07/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
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 table:

Anaphylactic Reaction

Section 10
Change of date to:

6th May 2009
Updated on 18/02/2009 and displayed until 20/05/2009
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 3


Deletion of text:

‘A white to off-white nebuliser suspension.’

 

Section 6.1

 

Change of text:

‘Water purified’ changed to ‘Water for injections’.

 

Section 6.3

 

Deletion of text:

‘Use Respule within 12 hours of opening.’

 

Addition of text:

‘If only 1ml of suspension is used, the remaining suspension is not sterile and should be discarded immediately.

See section 6.4’

 

Section 10

 

Change of date:
‘3rd February 2009’
Updated on 14/07/2008 and displayed until 18/02/2009
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:   28-May-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.2

First paragraph.  Additional text:

The highest dose (2 mg per day) for children under 12 years should only be considered in children with severe asthma and during limited periods.

 

Section 10

Date of revision of text: 28 May 2008
Updated on 12/04/2005 and displayed until 14/07/2008
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • 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 25/10/2004 and displayed until 12/04/2005
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
Updated on 18/07/2002 and displayed until 25/10/2004
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 18/07/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 21/08/2001 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
Updated on 15/02/2000 and displayed until 21/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  budesonide