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Alvesco 160 Inhaler

Last Updated on eMC 07-Jun-2017 View document  | AstraZeneca UK Limited Contact details

Versions

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 07-Jun-2017 and displayed until Current

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

Date of revision of text on the SPC: 30-May-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2 – Change to posology
Section 5.1 – Addition of information relating to a trial
Section 7 – Deletion of Takeda as MAH and addition of AstraZeneca as MAH
Section 8 – Change to licence number
Section 10 – Amendment to date of revision of text

Updated on 15-Jul-2014 and displayed until 07-Jun-2017

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 19-May-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4.2 Posology and method of administration:

Added: Elderly and patients with renal or hepatic impairment
Deleted:Specific patient groups
Added:Paediatric population

Added:

Method of administration

Precautions to be taken before handling or administering the medicinal product


4.8 Undesirable effects - how to report:

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

5.2 Pharmacokinetic properties:

Renal or hepatic insufficiency, elderly changed to Elderly
Renal or hepatic impairment seperate heading

6.6 Special precautions for disposal and other handling:
Added:

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

10. DATE OF REVISION OF THE TEXT
Changed to: 19th May 2014

Updated on 18-Dec-2012 and displayed until 15-Jul-2014

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 30-Nov-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7: Change to Marketing Authorisation Holder to Takeda GmbH
Section 10: Change to Date of Revision of Text to 30/11/12

Updated on 09-Jun-2011 and displayed until 18-Dec-2012

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects

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:

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".

Updated on 24-Feb-2010 and displayed until 09-Jun-2011

Reasons for adding or updating:

  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text

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:



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

Updated on 23-Nov-2009 and displayed until 24-Feb-2010

Reasons for adding or updating:

  • Removal of Black Triangle

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:

In Section 1, the Black Triangle Symbol has been removed.

Updated on 22-Apr-2009 and displayed until 23-Nov-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: 19-Feb-2009

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 4.8, Undesirable Effects, has been updated to change the frequency of some adverse events.

Updated on 02-Feb-2009 and displayed until 22-Apr-2009

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic Properties

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:

Change to Sections 4.2 and 5.1 to clairify the high dose regimen following a Commission Decision after repeat use MRP.

Updated on 25-Feb-2008 and displayed until 02-Feb-2009

Reasons for adding or 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
  • Company name change or merger

Date of revision of text on the SPC: 01-Jan-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

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

Updated on 22-May-2007 and displayed until 24-May-2007

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic Properties

Date of revision of text on the SPC: 01-Jan-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

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.

Updated on 24-May-2007 and displayed until 25-Feb-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 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Jan-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

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

Updated on 18-Dec-2006 and displayed until 22-May-2007

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC: 01-Nov-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

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

Updated on 24-Apr-2006 and displayed until 18-Dec-2006

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic Indications

Updated on 05-May-2005 and displayed until 24-Apr-2006

Reasons for adding or updating:

  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 4.1 - Therapeutic Indications
  • 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 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 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
  • Addition of Legal Category

Updated on 28-Apr-2005 and displayed until 28-Apr-2005

Reasons for adding or updating:

  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 4.1 - Therapeutic Indications
  • 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 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 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
  • Addition of Legal Category
  • Pending awaiting re-submission

Updated on 15-Feb-2005 and displayed until 28-Apr-2005

Reasons for adding or updating:

  • New SPC for new product

Company contact details

AstraZeneca UK Limited

Company image
Address

Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU

Fax

+44 (0)1582 838 000

Medical Information e-mail
Medical Information Fax

+44 (0)1582 838 003

Telephone

+44 (0)1582 836 000

Medical Information Direct Line

0800 783 0033

Customer Care direct line

+44 (0)1582 837 837

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?

Active ingredients

ciclesonide

Legal categories

POM - Prescription Only Medicine

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