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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories
Millbank House, Arkle Road, Sandyford, Dublin 18, Ireland
Telephone: +353 1 206 3800
Fax: +353 1 294 5104
Medical Information e-mail: info@mundipharma.ie
Summary of Product Characteristics last updated on medicines.ie: 16/01/2012
SPC MST Continus Suspension

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

Updated on 16/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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 revision of the text
Date of revision of text on the SPC:   01-Dec-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 1

100 and 200 mg strengths have been deleted.

Section 2

100 and 200  mg strengths have been deleted.

Section 4.2

100 and 200 mg strengths have been deleted.

Section 7

Marketing Authorisation holder is now
Mundipharma Pharmaceuticals Limited
Millbank House
Arkle Road
Sandyford
Dublin 18
Ireland

Section 8

PA  number is now PA 1688/4/8-10

Section 9

100 and 200 mg strengths have been deleted

Section 10

Date of Revision of the Text - December 2011
Updated on 24/05/2011 and displayed until 16/01/2012
Reasons for adding or updating:
  • 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 10 - Date of revision of the text
Date of revision of text on the SPC:   01-May-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
             Section 4.4

"Concomitant use of alcohol and MST CONTINUS suspension may increase the undesirable effects of MST CONTINUS suspension; concomitant use should be avoided." has been added.

Section 4.5
Morphine potentiates the effects of tranquillisers, anaesthetics, phenothiazines, hypnotics, sedatives, muscle relaxants and antihypertensives. Interactive effects resulting in respiratory depression, hypotension, profound sedation, or coma may result if these drugs are taken in combination with the usual doses of morphine. The word 'alcohol' has been removed from this sentence.

"Alcohol may enhance the pharmacodynamic effects of MST CONTINUS suspension; concomitant use should be avoided." has been added.

    

    
Updated on 03/05/2011 and displayed until 24/05/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   01-Feb-2008
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Corrections to section 4.4

"Pre-operative administration of MST CONTINUS suspension is not recommended" has been removed.
"convulsive disorders" has been changed to convulsion disorders.
"and in patients with" has been added before "raised intracranial pressure" in the first sentence.
Updated on 15/03/2007 and displayed until 03/05/2011
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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.2 Posology Controlled release granules statement about potentially fatal dose of morphine
 
Section 4.2 epilepsy added, Ponceau 4R statement added and use in caution in further disorders added
 
Section 4.5 Medicines that block action of Acetylcholine statment added. riframpicin statement added and concomitant use of ritonavir added.

Section 4.8 undesirable effects tabulated and listed according to organ class
 
 
Updated on 23/06/2003 and displayed until 15/03/2007
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Morphine Sulphate