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Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU
Telephone: +44 (0)1992 467 272
Fax: +44 (0)1992 479 292
Medical Information e-mail: medicalinformationuk@merck.com

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: 17/10/2011
SPC Asmanex Twisthaler 400 micrograms Inhalation Powder

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 17/10/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   14-May-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
In section 4.8 - dyspnea has been added.
Updated on 06/06/2011 and displayed until 17/10/2011
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:   14-May-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Section 4.8 changes:

Removal of the following sentence: There was no suggestion of an increased risk of undesirable effects in adolescents or patients 65 years of age or older.

Also the adverse event dysphonia has been relocated in the table and can now be found under the heading - Respiratory, thoracic and mediastinal disorders
Updated on 22/03/2011 and displayed until 06/06/2011
Reasons for adding or updating:
  • 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 6.1 - List of Excipients
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   31-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


In section 4.5 the active name has been written out fully, so now reads mometasone furoate.

 

In section 4.6 it is now stated that breast-feeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.

 

Section 4.8 table now includes Immune System disorders, asthma aggravation. There is also additional information on Bronchospasm and how the patient should discontinue Asmanex immediately if this is to occur.

 

Section 6.1 now references that lactose anhydrous contains trace amounts of milk protein.

 

Section 6.5 makes reference to the strength of the product.

 
Updated on 28/02/2011 and displayed until 22/03/2011
Reasons for adding or updating:
  • Addition of separate SPCs covering individual presentations
  • 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:   31-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Change of ownership from Schering-Plough Ltd to Merck Sharpe & Dohme Limited. Therefore the following sections have been updated with the new details.

MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UK

MARKETING AUTHORISATION NUMBER

 

PL 00025/0589

DATE OF REVISION OF THE TEXT

January 2011

 
Updated on 14/01/2008 and displayed until 28/02/2011
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 4.8 - Undesirable Effects
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • 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:   05/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Due to extensive updates please follow the link below:

http://emc.medicines.org.uk/emc/industry/Changedetails_Asmanex.doc
Updated on 24/01/2006 and displayed until 14/01/2008
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 10 (date of (partial) revision of the text
Updated on 28/07/2004 and displayed until 24/01/2006
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 6.1 - List of Excipients
Updated on 17/12/2003 and displayed until 28/07/2004
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 21/01/2003 and displayed until 17/12/2003
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  mometasone furoate