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Napp Pharmaceuticals Limited
Cambridge Science Park, Milton Road, Cambridge, Cambridgeshire, CB4 0GW
Telephone: +44 (0)1223 424 444
Fax: +44 (0)1223 424 441
WWW: http://www.napp.co.uk
Medical Information Fax: +44 (0)1223 424 912

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: 24/05/2011
SPC MST Continus suspensions 20, 30, 60, 100 and 200 mg

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 24/05/2011 and displayed until Current
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:   POM
Black Triangle (CHM):   NO

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 12/01/2011 and displayed until 24/05/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   18-Feb-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2.  Now reads "for full list of" excipients see 6.1.

Section 4.9 Signs of morphine toxicity and overdosage are "drowsiness" has been added.

                  MST CONTINUS suspension will continue to release and add to the morphine load for up to ("12 hours" has been changed to "24 hours") after administration.
Updated on 25/09/2009 and displayed until 12/01/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   18-Feb-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.4  

Should paralytic ileus be suspected or occur during use, MST CONTINUS suspension should be discontinued immediately.  Patients about to undergo additional pain relieving procedures (e.g. surgery, plexus blockade) should not receive MST CONTINUS suspension for 24 hours prior to the intervention.  If further treatment with MST CONTINUS suspension is indicated, then the dosage should be adjusted to the new post-operative requirement. 

 This paragraph has been amended.   
Updated on 23/09/2009 and displayed until 25/09/2009
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 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   18-Feb-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 -  addition of severe cor pulmonale, patients with a history of substance abuyse. Not recommended pre operatively or within 24 hours hours post operatively. Tolerance and abuse profiles aded.

Section 4.5 additional interactions added

4.8 Undesireable effects listed as common or uncommon and updated as per CCDS

4.9 crushing and taking contents of controlled release forms sentance added.

5.1 - Additional data added (CNS, GI, CV, Endocrine and other pharmacological effects) as per CCDS
Updated on 15/03/2007 and displayed until 23/09/2009
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.4 - Special warnings and precautions for Use
  • 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:   11/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 3: Pink granules added
Section 4: warning of fatal dose by breaking/chewing granules added.
Section 4.4: morphine may lower epilepsy threshold  statement added. Ponceau 4R allergic reactions statement added.
Section 4.5 interactions updated.
Section 4.8 Underirable effects tabulated as common and uncommon. Some additional affects added.
Section 10 date of revision updated
Updated on 25/09/2002 and displayed until 15/03/2007
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 4.3 - Contra-indications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 28/02/2002 and displayed until 25/09/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 14/08/2001 and displayed until 28/02/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 20/10/2000 and displayed until 14/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 20/10/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  morphine sulphate