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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: 26/05/2011
SPC Sevredol tablets 10mg, 20mg and 50mg

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 26/05/2011 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 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   04-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
            Section 4.4
            severe bronchial asthma has been added to the first paragraph.
           

'Hyperalgesia that will not respond to a further dose increase of morphine sulphate may very rarely occur in particular in high doses. A morphine sulphate dose reduction or change in opioid may be required.' has been added

            Section 4.5

'Medicinal products that block the action of acetylcholine, for example antihistamines, anti-parkinsons and anti-emetics, may interact with morphine to potentiate the anticholinergic adverse effects.' has been added.

Section 4.8
Section has been rewritten

Section 4.9
'Overdose can result in death' has been rewritten.
'Oral activated charcoal (50g) for adults, 1g/kg for children) may be considered if a substantial amount has been ingested within one hour, provided the airway can be protected.' has been added. 

 
Updated on 03/12/2007 and displayed until 26/05/2011
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   11/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 5.1 Pharmacodynamic properties has been re-written
Updated on 31/07/2007 and displayed until 03/12/2007
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 10 date of revision of the text
Date of revision of text on the SPC:   07/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Sections 4.4, 4.5, 4.8 and 4.9 updated inline with company core data sheet
Section 10  revision date updated
Updated on 31/08/2006 and displayed until 31/07/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 12/06/2006 and displayed until 31/08/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 29/06/2005 and displayed until 12/06/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 10 (date of (partial) revision of the text
Updated on 17/04/2003 and displayed until 29/06/2005
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 07/06/2002 and displayed until 17/04/2003
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
Updated on 17/08/2001 and displayed until 07/06/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 16/08/2001 and displayed until 17/08/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 20/10/2000 and displayed until 16/08/2001
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