Updated on 09/06/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 18-May-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Addition of wording to sections 4.4 and 4.8 following an MHRA request regarding "Risk of psychiatric adverse drug reactions to inhaled and intranasal corticosteroids and risk of non-psychiatric systemic adverse drug reactions to intranasal corticosteroids".
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Updated on 24/02/2010 and displayed until 09/06/2011
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Reasons for adding or updating:
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 11-Nov-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
16 April 2004 / 28th September 2009
10. DATE OF REVISION OF THE TEXT
19 February 2009 11th November 2009
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Updated on 23/11/2009 and displayed until 24/02/2010
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Reasons for adding or updating:
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Removal of Black Triangle
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| Date of revision of text on the SPC: 11-Nov-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In Section 1, the Black Triangle Symbol has been removed.
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Updated on 22/04/2009 and displayed until 23/11/2009
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 19-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 4.8, Undesirable Effects, has been updated to change the frequency of some adverse events.
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Updated on 02/02/2009 and displayed until 22/04/2009
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 24-Nov-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Change to Sections 4.2 and 5.1 to clairify the high dose regimen following a Commission Decision after repeat use MRP.
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Updated on 25/02/2008 and displayed until 02/02/2009
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 10 date of revision of the text
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Company name change or merger
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| Date of revision of text on the SPC: 01/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 7: Change of name of MAH
Section 8: Change of company number reflecting change of name of MAH
Section 10: Updated date of text revision
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Updated on 22/05/2007 and displayed until 25/02/2008
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 01/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 a higher dose of Alvesco for a short period [see section 5.1] or a course of oral corticosteroids
This is the modification and now includes a reference to section 5.1
Section 5.1
In a 12-week study of 680 severe asthmatics, previously treated with 500 – 1000 micrograms fluticasone propionate per day or equivalent, 87.3% and 93.3% of patients remained exacerbation-free during treatment with 160 or 640 micrograms of ciclesonide, respectively. Both ciclesonide doses resulted in comparable FEV1 values at 12 weeks. Treatment-related adverse events were seen in 3.8% and 5% of patients treated with 160 or 640 micrograms per day of ciclesonide respectively.
The above paragragh has been added in line with the extension to the current licence.
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Updated on 24/05/2007 and displayed until 22/05/2007
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.3 - Preclinical Safety Data
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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4.2 Second paragraph: 'The recommended dose of Alvesco is 160 micrograms once daily, which leads to asthma control in the majority of patients. Dose reduction to 80 micrograms once daily may be an effective maintenance dose for some patients.'
Fifth paragraph: Fourth sentence - ' In this situation, ......etc.. (ending with) ....Severe asthma exacerbations should be managed in the usual way.
4.4 Last paragraph: 'Concomitant treatment ......etc (ending with) ....(see section 4.5)'
4.5 Second paragraph: 'In a drug-drug interaction study.............etc (ending with) ...risk of systemic side effects of corticosteroids .'
5.1 Last paragraph: 'In a 12-week study of 680 severe asthmatics .........................(ending with) day of ciclesonide respectively'.
5.3 Third paragraph: ' A treatment-related effect.......etc (ending with) to humans is unknown'.
10 Date of revision of the text - January 2007
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Updated on 18/12/2006 and displayed until 24/05/2007
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 11/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Very rare
(< 1/10,000, incl. isolated reports)
Immune System Disorders
Immediate or delayed hypersensitivity reactions such as angioedema with swelling of lips, tongue and pharynx
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Updated on 24/04/2006 and displayed until 18/12/2006
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Updated on 05/05/2005 and displayed until 24/04/2006
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Reasons for adding or updating:
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Change to section 2 - qualitative and quantitative composition
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Change to section 3 - pharmaceutical form
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Change to section 4.1 - Therapeutic Indications
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 5.3 - Preclinical Safety Data
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Change to section 6.1 - List of Excipients
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 6. 6 - Instruction for Use/Handling
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Change to section 10 (date of (partial) revision of the text
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Addition of Legal Category
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Updated on 28/04/2005 and displayed until 05/05/2005
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Reasons for adding or updating:
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Change to section 2 - qualitative and quantitative composition
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Change to section 3 - pharmaceutical form
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Change to section 4.1 - Therapeutic Indications
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 5.3 - Preclinical Safety Data
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Change to section 6.1 - List of Excipients
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 6. 6 - Instruction for Use/Handling
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Change to section 10 (date of (partial) revision of the text
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Addition of Legal Category
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Pending awaiting re-submission
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Updated on 15/02/2005 and displayed until 28/04/2005
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Reasons for adding or updating:
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